63. 特発性血小板減少性紫斑病 Idiopathic thrombocytopenic purpura Clinical trials / Disease details


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

  
35 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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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
14EUCTR2019-003451-11-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
15EUCTR2019-000884-26-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
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-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
18EUCTR2019-000884-26-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
19EUCTR2019-003451-11-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
20EUCTR2019-000884-26-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
21EUCTR2019-000884-26-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
22EUCTR2019-003451-11-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
23EUCTR2019-000884-26-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
24EUCTR2019-000884-26-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
25EUCTR2019-003451-11-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
26EUCTR2019-000884-26-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
27EUCTR2015-003984-12-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
28EUCTR2015-003984-12-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
29EUCTR2015-003984-12-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
30EUCTR2015-003984-12-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
31EUCTR2015-003984-12-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
32NCT02718716
(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
33EUCTR2015-003984-12-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
34EUCTR2015-003984-12-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
35EUCTR2015-003984-12-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