271. 強直性脊椎炎 Ankylosing spondylitis Clinical trials / Disease details
臨床試験数 : 563 / 薬物数 : 372 - (DrugBank : 72) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 145
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-JapicCTI-205414 | 12/12/2020 | 18/08/2020 | A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including 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 | Nonradiographic axial spondyloarthritis / Ankylosing spondylitis | Intervention 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. | NULL | recruiting | 18 | BOTH | 30 | Phase 3 | Japan, Asia except Japan, North America, Europe | |
| 2 | EUCTR2019-004163-47-GB (EUCTR) | 08/10/2020 | 05/08/2020 | A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including 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 SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 3 | EUCTR2019-004163-47-DE (EUCTR) | 23/07/2020 | 27/04/2020 | 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 | 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 SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 4 | EUCTR2019-004163-47-HU (EUCTR) | 16/06/2020 | 01/04/2020 | A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including 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 SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | United States;Spain;Turkey;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 5 | NCT04436640 (ClinicalTrials.gov) | June 16, 2020 | 15/6/2020 | A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including 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;Ankylosing Spondylitis;r-axSpa | Drug: Bimekizumab | UCB Biopharma SRL | NULL | Enrolling by invitation | 18 Years | N/A | All | 485 | Phase 3 | United States;Belgium;Bulgaria;China;Czechia;France;Germany;Hungary;Japan;Netherlands;Poland;Spain;Turkey;United Kingdom |
| 6 | EUCTR2019-004163-47-BG (EUCTR) | 04/06/2020 | 14/05/2020 | A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including 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 SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Japan;China;Netherlands;Germany;Bulgaria;Poland;Belgium;Hungary;Czech Republic;France;United Kingdom;Turkey;Spain;United States | ||
| 7 | EUCTR2019-004163-47-CZ (EUCTR) | 26/05/2020 | 07/04/2020 | A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including 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 SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 8 | JPRN-JapicCTI-194860 | 30/9/2019 | 16/07/2019 | A 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 | Intervention 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., Ltd | NULL | complete | 18 | BOTH | 15 | Phase 3 | Japan, Asia except Japan, North America | |
| 9 | EUCTR2017-003065-95-NL (EUCTR) | 03/07/2019 | 25/07/2019 | A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitis | A 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 SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Netherlands;Germany;China;Japan | ||
| 10 | EUCTR2017-003065-95-GB (EUCTR) | 01/07/2019 | 29/03/2019 | A 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 SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 11 | EUCTR2017-003065-95-BG (EUCTR) | 19/06/2019 | 10/05/2019 | A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitis | A 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 SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 12 | EUCTR2017-003065-95-CZ (EUCTR) | 17/06/2019 | 04/06/2019 | A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitis | A 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 SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 13 | EUCTR2017-003065-95-FR (EUCTR) | 11/06/2019 | 21/05/2019 | A 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 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 SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Netherlands;China;Japan | ||
| 14 | EUCTR2017-003065-95-DE (EUCTR) | 11/06/2019 | 04/02/2019 | A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitis | A 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 SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 15 | EUCTR2017-003065-95-ES (EUCTR) | 29/04/2019 | 21/05/2019 | A 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 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 SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 16 | NCT03928743 (ClinicalTrials.gov) | April 25, 2019 | 23/4/2019 | A 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 | Drug: Bimekizumab;Other: Placebo | UCB Biopharma SRL | NULL | Active, not recruiting | 18 Years | N/A | All | 332 | Phase 3 | United States;Belgium;Bulgaria;China;Czechia;France;Germany;Hungary;Japan;Netherlands;Poland;Spain;Turkey;United Kingdom |
| 17 | EUCTR2017-003065-95-BE (EUCTR) | 19/04/2019 | 26/02/2019 | A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitis | A 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 SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 18 | EUCTR2017-003065-95-HU (EUCTR) | 16/04/2019 | 25/03/2019 | A 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 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 SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan | ||
| 19 | EUCTR2017-000957-37-NL (EUCTR) | 18/07/2018 | 31/10/2017 | Study 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 SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Germany;Netherlands;Moldova, Republic of | ||
| 20 | EUCTR2017-001002-15-DE (EUCTR) | 22/01/2018 | 20/09/2017 | A Study to Evaluate the Long Term Safety and Efficacy ofBimekizumab in Subjects with Ankylosing Spondylitis | A 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 SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 285 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Poland;Ukraine;Russian Federation;Bulgaria;Germany | ||
| 21 | EUCTR2017-001002-15-BG (EUCTR) | 18/12/2017 | 26/09/2017 | A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis | A 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 SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 285 | Phase 2 | United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Russian Federation;Bulgaria;Germany | ||
| 22 | NCT03355573 (ClinicalTrials.gov) | November 28, 2017 | 22/11/2017 | A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis | A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Bimekizumab | UCB Biopharma SRL | NULL | Active, not recruiting | 18 Years | N/A | All | 256 | Phase 2 | United States;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine |
| 23 | EUCTR2017-000957-37-DE (EUCTR) | 15/11/2017 | 14/07/2017 | Study to test the efficacy and safety of bimekizumab andcertolizumab 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 SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Netherlands;United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Germany;Moldova, Republic of | ||
| 24 | EUCTR2017-001002-15-ES (EUCTR) | 13/11/2017 | 02/10/2017 | A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis | A 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 SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 285 | Phase 2 | Hungary;Spain;Germany | ||
| 25 | EUCTR2017-001002-15-CZ (EUCTR) | 01/11/2017 | 29/08/2017 | A Study to Evaluate the Long Term Safety and Efficacy ofBimekizumab in Subjects with Ankylosing Spondylitis | A 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 SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 285 | Phase 2 | Hungary;Czech Republic;Spain;Bulgaria;Germany | ||
| 26 | EUCTR2017-001002-15-HU (EUCTR) | 25/10/2017 | 29/08/2017 | A Study to Evaluate the Long Term Safety and Efficacy ofBimekizumab in Subjects with Ankylosing Spondylitis | A 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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 285 | Phase 2 | Hungary | ||
| 27 | EUCTR2017-000957-37-GR (EUCTR) | 05/10/2017 | 13/09/2017 | Study to test the efficacy and safety of Bimekizumab andCertolizumab 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 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 SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Moldova, Republic of;Germany;Netherlands;Russian Federation;Australia;Poland;Greece;Czech Republic;United States | ||
| 28 | NCT03215277 (ClinicalTrials.gov) | October 4, 2017 | 5/7/2017 | A Study 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 | Drug: Bimekizumab;Drug: Certolizumab pegol;Other: Placebo | UCB Biopharma S.P.R.L. | NULL | Completed | 18 Years | N/A | All | 76 | Phase 2 | United States;Czechia;Germany;Greece;Moldova, Republic of;Netherlands;Poland;Russian Federation;Australia |
| 29 | EUCTR2017-000957-37-CZ (EUCTR) | 25/09/2017 | 12/07/2017 | Study 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 SPRL | NULL | Not 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): no | United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Netherlands;Germany;Moldova, Republic of | ||
| 30 | EUCTR2016-001102-42-GB (EUCTR) | 24/05/2017 | 22/03/2017 | 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 SPRL | NULL | Not 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): no | United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany;United Kingdom | ||
| 31 | EUCTR2016-001102-42-BG (EUCTR) | 10/02/2017 | 05/01/2017 | 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 SPRL | NULL | Not 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): no | United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany;United Kingdom | ||
| 32 | EUCTR2016-001102-42-DE (EUCTR) | 09/02/2017 | 16/11/2016 | 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 SPRL | NULL | Not Recruiting | Female: yes Male: yes | 285 | Phase 2 | United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany | ||
| 33 | EUCTR2016-001102-42-ES (EUCTR) | 28/12/2016 | 27/10/2016 | 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: 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 SPRL | NULL | Not Recruiting | Female: yes Male: yes | 285 | Phase 2 | United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany | ||
| 34 | EUCTR2016-001102-42-CZ (EUCTR) | 16/12/2016 | 03/11/2016 | 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 SPRL | NULL | Not 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): no | United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany;United Kingdom | ||
| 35 | EUCTR2016-001102-42-HU (EUCTR) | 21/11/2016 | 28/09/2016 | 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: 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 SPRL | NULL | Not Recruiting | Female: yes Male: yes | 285 | Phase 2 | United States;Czech Republic;Hungary;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany | ||
| 36 | NCT02963506 (ClinicalTrials.gov) | October 2016 | 10/11/2016 | A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis | 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 | Other: Placebo;Drug: Bimekizumab | UCB Biopharma S.P.R.L. | NULL | Completed | 18 Years | N/A | All | 303 | Phase 2 | United States;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine;Czech Republic |