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 Chronic inflammatory demyelinating polyneuropathy Clinical trials / Disease details


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

  
17 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
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Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
1NCT05014724
(ClinicalTrials.gov)
November 12, 202119/8/2021CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Drug: RozanolixizumabUCB Biopharma SRLNULLAvailable18 YearsN/AAllNULL
2EUCTR2018-004392-12-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
3EUCTR2018-004392-12-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
4EUCTR2018-004392-12-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
5EUCTR2018-004392-12-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
6EUCTR2018-004392-12-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
7NCT04051944
(ClinicalTrials.gov)
August 21, 20198/8/2019A 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)Drug: RozanolixizumabUCB Biopharma SRLNULLCompleted18 YearsN/AAll21Phase 2United States;Belgium;Denmark;France;Germany;Netherlands;Spain;United Kingdom
8EUCTR2018-004392-12-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
9EUCTR2018-004392-12-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
10EUCTR2016-002411-17-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
11EUCTR2016-002411-17-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
12EUCTR2016-002411-17-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
13EUCTR2016-002411-17-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
14EUCTR2016-002411-17-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
15EUCTR2016-002411-17-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
16EUCTR2016-002411-17-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
17NCT03861481
(ClinicalTrials.gov)
March 26, 20191/3/2019A 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)Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Drug: Rozanolixizumab;Other: PlaceboUCB Biopharma S.P.R.L.NULLCompleted18 YearsN/AAll34Phase 2United States;Belgium;Denmark;France;Germany;Netherlands;Spain;United Kingdom;Canada