271. 強直性脊椎炎 Ankylosing spondylitis Clinical trials / Disease details


臨床試験数 : 574 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146

  
36 trials found
No.TrialIDDate_
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PhaseCountries
1JPRN-JapicCTI-205414
12/12/202018/08/2020A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritisA Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis Nonradiographic axial spondyloarthritis / Ankylosing spondylitisIntervention name : UCB4940
INN of the intervention : bimekizumab
Dosage And administration of the intervention : 160mg administered by sc injection
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
UCB Japan Co., Ltd.NULLrecruiting18BOTH30Phase 3Japan, Asia except Japan, North America, Europe
2EUCTR2019-004163-47-GB
(EUCTR)
08/10/202005/08/2020A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritisA Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
3EUCTR2019-004163-47-DE
(EUCTR)
23/07/202027/04/2020A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
4EUCTR2019-004163-47-HU
(EUCTR)
16/06/202001/04/2020A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritisA Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3United States;Spain;Turkey;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
5NCT04436640
(ClinicalTrials.gov)
June 16, 202015/6/2020A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial SpondyloarthritisA Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial SpondyloarthritisAxial Spondyloarthritis;Ankylosing Spondylitis;r-axSpa;Nr-axSpaDrug: BimekizumabUCB Biopharma SRLNULLActive, not recruiting18 YearsN/AAll485Phase 3United States;Belgium;Bulgaria;China;Czechia;France;Germany;Hungary;Japan;Netherlands;Poland;Spain;Turkey;United Kingdom
6EUCTR2019-004163-47-BG
(EUCTR)
04/06/202014/05/2020A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritisA Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
7EUCTR2019-004163-47-CZ
(EUCTR)
26/05/202007/04/2020A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritisA Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
8JPRN-JapicCTI-194860
30/9/201916/07/2019A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing SpondylitisA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis Ankylosing SpondylitisIntervention name : UCB4940
INN of the intervention : bimekizumab
Dosage And administration of the intervention : 160mg administered by sc injection
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : -
UCB Japan Co., LtdNULLcomplete18BOTH15Phase 3Japan, Asia except Japan, North America
9EUCTR2017-003065-95-NL
(EUCTR)
03/07/201925/07/2019A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Netherlands;Germany;China;Japan
10EUCTR2017-003065-95-GB
(EUCTR)
01/07/201929/03/2019A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitis.A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
11EUCTR2017-003065-95-BG
(EUCTR)
19/06/201910/05/2019A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
12EUCTR2017-003065-95-CZ
(EUCTR)
17/06/201904/06/2019A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
13EUCTR2017-003065-95-FR
(EUCTR)
11/06/201921/05/2019A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Netherlands;China;Japan
14EUCTR2017-003065-95-DE
(EUCTR)
11/06/201904/02/2019A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
15EUCTR2017-003065-95-ES
(EUCTR)
29/04/201921/05/2019A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
16NCT03928743
(ClinicalTrials.gov)
April 25, 201923/4/2019A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing SpondylitisA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Bimekizumab;Other: PlaceboUCB Biopharma SRLNULLCompleted18 YearsN/AAll332Phase 3United States;Belgium;Bulgaria;China;Czechia;France;Germany;Hungary;Japan;Netherlands;Poland;Spain;Turkey;United Kingdom
17EUCTR2017-003065-95-BE
(EUCTR)
19/04/201926/02/2019A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
18EUCTR2017-003065-95-HU
(EUCTR)
16/04/201925/03/2019A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
19EUCTR2017-000957-37-NL
(EUCTR)
18/07/201831/10/2017Study to test the efficacy and safety of bimekizumab and certolizumab pegol in patients with active ankylosing spondylitisA Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab Pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Germany;Netherlands;Moldova, Republic of
20EUCTR2017-001002-15-DE
(EUCTR)
22/01/201820/09/2017A Study to Evaluate the Long Term Safety and Efficacy ofBimekizumab in Subjects with Ankylosing SpondylitisA Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis - BE AGILE 2 Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB BIOPHARMA SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
285Phase 2United States;Hungary;Czech Republic;Canada;Spain;Poland;Ukraine;Russian Federation;Bulgaria;Germany
21EUCTR2017-001002-15-BG
(EUCTR)
18/12/201726/09/2017A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing SpondylitisA Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis - BE AGILE 2 Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
285Phase 2United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Russian Federation;Bulgaria;Germany
22NCT03355573
(ClinicalTrials.gov)
November 28, 201722/11/2017A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing SpondylitisA Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: BimekizumabUCB Biopharma SRLNULLCompleted18 YearsN/AAll256Phase 2United States;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine
23EUCTR2017-000957-37-DE
(EUCTR)
15/11/201714/07/2017Study to test the efficacy and safety of bimekizumab andcertolizumab pegol in patients with active ankylosing spondylitisA Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab Pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Netherlands;United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Germany;Moldova, Republic of
24EUCTR2017-001002-15-ES
(EUCTR)
13/11/201702/10/2017A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing SpondylitisA Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis - To assess the long term safety & tolerability of bimekizumab in subjects with ankylosing spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
285Phase 2Hungary;Spain;Germany
25EUCTR2017-001002-15-CZ
(EUCTR)
01/11/201729/08/2017A Study to Evaluate the Long Term Safety and Efficacy ofBimekizumab in Subjects with Ankylosing SpondylitisA Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis - To assess the long term safety & tolerability of bimekizumab in subjects with ankylosing spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
285Phase 2Hungary;Czech Republic;Spain;Bulgaria;Germany
26EUCTR2017-001002-15-HU
(EUCTR)
25/10/201729/08/2017A Study to Evaluate the Long Term Safety and Efficacy ofBimekizumab in Subjects with Ankylosing SpondylitisA Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis - To assess the long term safety & tolerability of bimekizumab in subjects with ankylosing spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB BIOSCIENCES GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
285Phase 2Hungary
27EUCTR2017-000957-37-GR
(EUCTR)
05/10/201713/09/2017Study to test the efficacy and safety of Bimekizumab andCertolizumab Pegol in patients with active ankylosing spondylitisA Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Other descriptive name: UCB4940
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab Pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Netherlands;Germany;Moldova, Republic of
28NCT03215277
(ClinicalTrials.gov)
October 4, 20175/7/2017A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing SpondylitisA Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Bimekizumab;Drug: Certolizumab pegol;Other: PlaceboUCB Biopharma S.P.R.L.NULLCompleted18 YearsN/AAll76Phase 2United States;Czechia;Germany;Greece;Moldova, Republic of;Netherlands;Poland;Russian Federation;Australia
29EUCTR2017-000957-37-CZ
(EUCTR)
25/09/201712/07/2017Study to test the efficacy and safety of bimekizumab and certolizumab pegol in patients with active ankylosing spondylitis A Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab Pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Czech Republic;Greece;Poland;Australia;Russian Federation;Netherlands;Germany;Moldova, Republic of
30EUCTR2016-001102-42-GB
(EUCTR)
24/05/201722/03/2017 A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing Spondylitis
MedDRA version: 19.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: bimekizumab
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
285 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany;United Kingdom
31EUCTR2016-001102-42-BG
(EUCTR)
10/02/201705/01/2017 A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: bimekizumab
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
285 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany;United Kingdom
32EUCTR2016-001102-42-DE
(EUCTR)
09/02/201716/11/2016A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: bimekizumab
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
285Phase 2United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany
33EUCTR2016-001102-42-ES
(EUCTR)
28/12/201627/10/2016A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing Spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: bimekizumab
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
285Phase 2United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany
34EUCTR2016-001102-42-CZ
(EUCTR)
16/12/201603/11/2016 A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: bimekizumab
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
285 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany;United Kingdom
35EUCTR2016-001102-42-HU
(EUCTR)
21/11/201628/09/2016A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing Spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: bimekizumab
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
285Phase 2United States;Czech Republic;Hungary;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany
36NCT02963506
(ClinicalTrials.gov)
October 201610/11/2016A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing SpondylitisA Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisOther: Placebo;Drug: BimekizumabUCB Biopharma S.P.R.L.NULLCompleted18 YearsN/AAll303Phase 2United States;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine;Czech Republic