UCB7665 ( DrugBank: - )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
11重症筋無力症30
14慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー14
63特発性血小板減少性紫斑病37

11. 重症筋無力症


臨床試験数 : 332 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-003230-20-BE
(EUCTR)
11/01/202107/10/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
230Phase 3United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;China;Japan
2EUCTR2020-003230-20-IT
(EUCTR)
15/12/202030/08/2021A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis - - Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: [UCB7665]
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;China;Japan
3EUCTR2020-003230-20-PL
(EUCTR)
14/12/202030/09/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;China;Japan
4EUCTR2020-003230-20-DE
(EUCTR)
02/12/202014/09/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;China;Japan
5EUCTR2020-003230-20-HU
(EUCTR)
01/12/202001/10/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
230Phase 3United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Georgia;Germany;China;Japan
6EUCTR2020-003230-20-GB
(EUCTR)
30/11/202002/09/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;China;Japan
7EUCTR2020-003230-20-DK
(EUCTR)
17/11/202006/10/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;China;Japan
8EUCTR2019-000969-21-DE
(EUCTR)
20/04/202005/11/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
276Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
9EUCTR2019-000969-21-PL
(EUCTR)
12/04/202020/02/2020A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
276Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany
10EUCTR2019-000969-21-CZ
(EUCTR)
24/02/202020/12/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
276Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
11EUCTR2019-000969-21-ES
(EUCTR)
14/02/202011/11/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
12EUCTR2019-000969-21-IT
(EUCTR)
15/01/202027/01/2021A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients WithGeneralized Myasthenia Gravis - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: [UCB7665]
INN or Proposed INN: rozanolixizumab
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
276Phase 3United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
13EUCTR2019-000969-21-GB
(EUCTR)
06/01/202015/10/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
276Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
14EUCTR2019-000968-18-PL
(EUCTR)
19/12/201909/07/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany
15EUCTR2019-000969-21-HU
(EUCTR)
04/12/201915/10/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany
16EUCTR2019-000968-18-DE
(EUCTR)
15/11/201910/07/2019A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
17EUCTR2019-000968-18-GB
(EUCTR)
14/11/201928/06/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients with Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3Russian Federation;Hong Kong;Hungary;United States;United Kingdom;Spain;Canada;Czech Republic;Belgium;Taiwan;Denmark;Poland;Italy;France;Germany
18EUCTR2019-000968-18-CZ
(EUCTR)
11/11/201913/08/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
19EUCTR2019-000969-21-DK
(EUCTR)
07/11/201917/10/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
276Phase 3United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
20EUCTR2019-000968-18-BE
(EUCTR)
14/10/201914/08/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
21EUCTR2019-000968-18-IT
(EUCTR)
25/09/201927/01/2021A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis.A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: [UCB7665]
INN or Proposed INN: rozanolixizumab
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
22EUCTR2019-000968-18-HU
(EUCTR)
25/09/201923/07/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany
23EUCTR2019-000968-18-DK
(EUCTR)
06/09/201924/06/2019A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
24EUCTR2019-000968-18-ES
(EUCTR)
28/08/201912/09/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis.A Phase 3, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
25EUCTR2016-002698-36-CZ
(EUCTR)
26/05/201703/04/2017Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. Moderate to severe myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany
26EUCTR2016-002698-36-ES
(EUCTR)
25/05/201731/03/2017Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. Moderate to severe myasthenia gravis
MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: UCB7665
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany
27EUCTR2016-002698-36-DK
(EUCTR)
19/05/201707/04/2017 Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. Moderate to severe myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
42 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany
28NCT03052751
(ClinicalTrials.gov)
May 15, 201710/2/2017Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia GravisMyasthenia GravisDrug: UCB7665;Other: PlaceboUCB Biopharma S.P.R.L.NULLCompleted18 YearsN/AAll43Phase 2United States;Belgium;Canada;Czechia;Denmark;Germany;Spain
29EUCTR2016-002698-36-DE
(EUCTR)
09/02/201728/11/2016Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. Moderate to severe myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany
30EUCTR2016-002698-36-BE
(EUCTR)
30/01/201729/11/2016Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. Moderate to severe myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Czech Republic;Canada;Spain;Belgium;Denmark;Germany

14. 慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー


臨床試験数 : 175 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-004392-12-NL
(EUCTR)
11/06/202009/09/2019A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathyAn Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
Other descriptive name: Rozanolixizumab
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
34Phase 2United States;France;Canada;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy
2EUCTR2018-004392-12-DE
(EUCTR)
29/04/202010/04/2019An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
Other descriptive name: Rozanolixizumab
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
34Phase 2France;United States;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy
3EUCTR2018-004392-12-GB
(EUCTR)
20/11/201901/04/2019A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathyAn Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
Other descriptive name: Rozanolixizumab
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
34Phase 2Canada;Netherlands;Belgium;United States;Denmark;United Kingdom;Italy;France;Germany;Spain
4EUCTR2018-004392-12-DK
(EUCTR)
29/10/201916/09/2019A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathyAn Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
Other descriptive name: Rozanolixizumab
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
34Phase 2France;United States;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy
5EUCTR2018-004392-12-FR
(EUCTR)
10/09/201913/05/2019A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathyAn Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
Other descriptive name: Rozanolixizumab
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
34Phase 2United States;France;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom
6EUCTR2018-004392-12-BE
(EUCTR)
20/08/201923/05/2019A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathyAn Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
Other descriptive name: Rozanolixizumab
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
34Phase 2France;United States;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom
7EUCTR2018-004392-12-ES
(EUCTR)
01/08/201911/06/2019A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathyAn Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
Other descriptive name: Rozanolixizumab
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
34Phase 2United States;France;Canada;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom
8EUCTR2016-002411-17-GB
(EUCTR)
23/07/201914/08/2019A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating PolyradiculoneuropathyA Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
Other descriptive name: ROZANOLIXIZUMAB
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
34 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom
9EUCTR2016-002411-17-FR
(EUCTR)
02/07/201919/07/2019A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating PolyradiculoneuropathyA Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
Other descriptive name: ROZANOLIXIZUMAB
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
34Phase 2United States;France;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom
10EUCTR2016-002411-17-NL
(EUCTR)
13/06/201902/04/2019A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating PolyradiculoneuropathyA Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
Other descriptive name: ROZANOLIXIZUMAB
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
34Phase 2United States;France;Canada;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy
11EUCTR2016-002411-17-DE
(EUCTR)
23/05/201904/04/2019A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating PolyradiculoneuropathyA Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
Other descriptive name: ROZANOLIXIZUMAB
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
34Phase 2France;United States;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy
12EUCTR2016-002411-17-ES
(EUCTR)
09/05/201911/04/2019A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating PolyradiculoneuropathyA Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
Other descriptive name: ROZANOLIXIZUMAB
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
34Phase 2United States;France;Canada;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom
13EUCTR2016-002411-17-BE
(EUCTR)
29/04/201908/02/2019A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating PolyradiculoneuropathyA Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
Other descriptive name: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
34Phase 2United States;France;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy
14EUCTR2016-002411-17-DK
(EUCTR)
11/04/201920/02/2019A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating PolyradiculoneuropathyA Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
Other descriptive name: ROZANOLIXIZUMAB
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
34Phase 2United States;France;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy

63. 特発性血小板減少性紫斑病


臨床試験数 : 391 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-000884-26-HR
(EUCTR)
09/09/202124/11/2021A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Netherlands;Japan;Moldova, Republic of;Korea, Republic of
2EUCTR2019-003451-11-DK
(EUCTR)
17/06/202119/04/2021A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
90Phase 3Serbia;United States;Czechia;Hong Kong;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany;China
3EUCTR2019-000884-26-GR
(EUCTR)
25/05/202101/04/2021A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Netherlands;Japan;Moldova, Republic of;Korea, Republic of
4EUCTR2019-000883-40-DE
(EUCTR)
09/04/202110/09/2020A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP)An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Denmark;Netherlands;China;Moldova, Republic of;United States;Serbia;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;France;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
5EUCTR2019-000883-40-BG
(EUCTR)
25/11/202024/08/2020A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP)An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Serbia;United States;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
6EUCTR2019-000883-40-GB
(EUCTR)
29/10/202011/09/2020A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP)An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Japan;China
7EUCTR2019-000883-40-PL
(EUCTR)
09/10/202025/08/2020A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP)An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Japan;China
8EUCTR2019-000883-40-CZ
(EUCTR)
05/10/202012/08/2020A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP)An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
210Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;China;Japan
9EUCTR2019-000883-40-HU
(EUCTR)
29/09/202011/08/2020A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP)An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
210Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;China;Japan
10EUCTR2019-003451-11-FR
(EUCTR)
08/09/202013/02/2020A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Netherlands;China;Japan
11EUCTR2019-003451-11-DE
(EUCTR)
17/08/202014/02/2020A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany
12EUCTR2019-003451-11-AT
(EUCTR)
13/07/202028/02/2020A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
90Phase 3Serbia;United States;Czechia;Hong Kong;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany;China
13EUCTR2019-000884-26-AT
(EUCTR)
06/07/202028/02/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
90Phase 3United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Netherlands;Japan;Moldova, Republic of;Korea, Republic of;United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation
14EUCTR2019-000884-26-IT
(EUCTR)
09/06/202017/06/2021A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants with Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: [UCB7665]
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Italy;France;Netherlands;Moldova, Republic of;China;Czechia;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan
15EUCTR2019-003451-11-CZ
(EUCTR)
28/05/202026/02/2020A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany
16EUCTR2019-003451-11-NL
(EUCTR)
22/05/202003/03/2020A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
105Phase 3Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;China;Japan;United States;Taiwan
17EUCTR2019-000884-26-NL
(EUCTR)
22/05/202003/03/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
105Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Japan;China
18EUCTR2019-000884-26-FR
(EUCTR)
11/05/202026/05/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;China;Japan
19EUCTR2019-003451-11-IT
(EUCTR)
04/05/202027/01/2021A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: [UCB7665]
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;China;Japan
20EUCTR2019-000884-26-BG
(EUCTR)
30/04/202004/02/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Netherlands;Japan;Moldova, Republic of;Korea, Republic of
21EUCTR2019-003451-11-BG
(EUCTR)
30/04/202004/02/2020A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Serbia;Czechia;Taiwan;Hong Kong;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Romania;Denmark;Bulgaria;Germany;Netherlands;China
22EUCTR2019-000884-26-CZ
(EUCTR)
23/04/202025/02/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Netherlands;Moldova, Republic of;Japan;Korea, Republic of
23EUCTR2019-000884-26-ES
(EUCTR)
22/04/202028/02/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
105Phase 3United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;France;Netherlands;China;Moldova, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
24EUCTR2019-003451-11-ES
(EUCTR)
22/04/202028/02/2020A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
105Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany;China;Japan
25EUCTR2019-000884-26-GB
(EUCTR)
20/04/202016/03/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Serbia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Japan
26EUCTR2019-000884-26-HU
(EUCTR)
13/04/202011/02/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Netherlands;Japan;Moldova, Republic of;Korea, Republic of
27EUCTR2019-003451-11-PL
(EUCTR)
25/03/202011/02/2020A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Serbia;Czechia;Taiwan;Hong Kong;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Germany;Netherlands;China
28EUCTR2019-000884-26-PL
(EUCTR)
20/03/202003/02/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 Primary Immune Thrombocytopenia
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
90Phase 3Netherlands;Moldova, Republic of;Japan;United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Korea, Republic of
29EUCTR2015-003984-12-BG
(EUCTR)
15/08/201702/06/2017A study to test the safety of UCB7665 in patients with low levels of platelets.A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: UCB7665
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
66Phase 2Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
30EUCTR2015-003984-12-LT
(EUCTR)
14/07/201702/05/2017A study to test the safety of UCB7665 in patients with low levels of platelets.A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA
MedDRA version: 19.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: UCB7665
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
31EUCTR2015-003984-12-PL
(EUCTR)
09/06/201606/04/2016A study to test the safety of UCB7665 in patients with low levels of platelets.A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: UCB7665
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
132 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Lithuania;United Kingdom;Italy;Czech Republic;Poland;Belgium;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
32EUCTR2015-003984-12-IT
(EUCTR)
11/04/201605/11/2020A study to test the safety of UCB7665 in patients with low levels of platelets.A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA - - Primary immune thrombocytopenia (ITP)
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: UCB7665
Product Code: [UCB7665 ]
INN or Proposed INN: UCB7665
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
66Phase 2Czechia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
33EUCTR2015-003984-12-CZ
(EUCTR)
16/03/201622/12/2015A study to test the safety of UCB7665 in patients with low levels of platelets.A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: UCB7665
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
34NCT02718716
(ClinicalTrials.gov)
March 201611/3/2016Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune ThrombocytopeniaA Multicenter, Open-label, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Primary Immune ThrombocytopeniaThrombocytopeniaDrug: UCB7665UCB Biopharma S.P.R.L.ParexelCompleted18 YearsN/AAll66Phase 2Australia;Bulgaria;Czechia;Georgia;Germany;Italy;Moldova, Republic of;Poland;Romania;Spain;United Kingdom;Belgium;Czech Republic;Lithuania
35EUCTR2015-003984-12-ES
(EUCTR)
29/02/201613/01/2016A study to test the safety of UCB7665 in patients with low levels of platelets.A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA Primary immune thrombocytopenia (ITP)
MedDRA version: 18.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: UCB7665
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Moldova, Republic of
36EUCTR2015-003984-12-BE
(EUCTR)
22/02/201615/01/2016A study to test the safety of UCB7665 in patients with low levels of platelets.A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA
MedDRA version: 19.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: UCB7665
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
37EUCTR2015-003984-12-DE
(EUCTR)
05/02/201623/11/2015A study to test the safety of UCB7665 in patients with low levels of platelets.A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA
MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: UCB7665
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of