Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT03370133 BE VIVID | Psoriasis | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 Week 16 | Bimekizumab 320 mg Q4W (RS) | 85.0 percentage of participants |
| Placebo (RS) | 4.8 percentage of participants | |||
| Ustekinumab (RS) | 49.7 percentage of participants | |||
| NCT03370133 BE VIVID | Psoriasis | Percentage of Participants With an Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 16 Week 16 | Bimekizumab 320 mg Q4W (RS) | 84.1 percentage of participants |
| Placebo (RS) | 4.8 percentage of participants | |||
| Ustekinumab (RS) | 53.4 percentage of participants | |||
| NCT03410992 BE READY | Psoriasis | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 At Week 16 | Bimekizumab 320 mg Q4W (RS) | 90.8 percentage of participants |
| Placebo (RS) | 1.2 percentage of participants | |||
| NCT03410992 BE READY | Psoriasis | Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16 At Week 16 | Bimekizumab 320 mg Q4W (RS) | 92.6 percentage of participants |
| Placebo (RS) | 1.2 percentage of participants | |||
| NCT03412747 BE SURE | Psoriasis | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 Week 16 | Adalimumab (RS) | 47.2 percentage of participants |
| Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) | 86.2 percentage of participants | |||
| NCT03412747 BE SURE | Psoriasis | Percentage of Participants With an Investigator's Global Assessment (IGA) Response (Clear or Almost Clear With at Least 2-Category Improvement Relative to Baseline) at Week 16 Week 16 | Adalimumab (RS) | 57.2 percentage of participants |
| Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) | 85.3 percentage of participants | |||
| NCT03536884 BE RADIANT | Psoriasis | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 Week 16 | ITP: Bimekizumab (BKZ) 320 mg Q4W | 61.7 percentage of participants |
| ITP: Secukinumab 300 mg Q4W | 48.9 percentage of participants | |||
| NCT03598790 BE BRIGHT | Psoriasis | Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP) From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period | Cohort A: BKZ 320 mg Q4W | 179.68 no. of new events per 100 subject-years |
| Cohort A: BKZ 320 mg Q8W | 97.83 no. of new events per 100 subject-years | |||
| Cohort A: Group A BKZ 320 mg Q8W | 79.02 no. of new events per 100 subject-years | |||
| Cohort A: Group B BKZ 320 mg Q4W/Q8W | 73.78 no. of new events per 100 subject-years | |||
| Cohort A: Group B BKZ 320 mg Q8W | 77.11 no. of new events per 100 subject-years | |||
| Cohort B: EP BKZ Total | 328.25 no. of new events per 100 subject-years | |||
| Cohort B: GPP BKZ Total | 188.71 no. of new events per 100 subject-years | |||
| Cohort B: PSO BKZ Total | 244.08 no. of new events per 100 subject-years | |||
| NCT03766685 | Psoriasis | Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-safety Syringe (SS)-1mL or the Bimekizumab-auto-injector (AI)-1mL at Week 8, After Training in Self-injection Technique Week 8 | Bimekizumab-SS-1mL 320 mg (FAS-s-1mL) | 100 percentage of participants |
| Bimekizumab -AI-1mL 320 mg (FAS-a-1mL) | 100 percentage of participants | |||
| NCT03766685 | Psoriasis | Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Week 8, After Training in Self-injection Technique Week 8 | Bimekizumab-AI-2mL 320 mg (FAS-a-2mL) | 94.7 percentage of participants |
| Bimekizumab-SS-2mL 320 mg (FAS-s-2mL) | 100 percentage of participants | |||
| NCT03895203 BE OPTIMAL | Arthritis, Psoriatic | Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 16 Week 16 | ADA 40 mg Q2W | 45.7 percentage of participants |
| BKZ 160 mg Q4W | 43.9 percentage of participants | |||
| Placebo | 10.0 percentage of participants | |||
| NCT03896581 BE COMPLETE | Arthritis, Psoriatic | Percentage of Participants With American College of Rheumatology 50 (ACR50) Response From Baseline to Week 16 | Bimekizumab 160mg | 43.4 percentage of participants |
| Placebo | 6.8 percentage of participants | |||
| NCT03928704 BE MOBILE 1 | Axial Spondyloarthritis | Percentage of Participants With Assessment of SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 16 Week 16 | Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population) | 33.3 percentage of participants |
| Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) | 47.7 percentage of participants | |||
| Placebo (up to Week 16) (China Extension Population) | 27.3 percentage of participants | |||
| Placebo (up to Week 16) (Global Population) | 21.4 percentage of participants | |||
| NCT03928743 BE MOBILE 2 | Spondylitis, Ankylosing | Percentage of Participants With Assessment of SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 16 Week 16 | Bimekizumab 160 mg Q4W (up to Week 16) | 44.8 percentage of participants |
| Placebo (up to Week 16) | 22.5 percentage of participants | |||
| NCT04109976 | Arthritis, Psoriatic | Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab Safety Syringe (BKZ-SS) or the Bimekizumab Auto-injector (BKZ-AI) at Week 4 Week 4 | BKZ-AI-1mL 160 mg Q4W | 100 percentage of participants |
| BKZ-SS-1mL 160 mg Q4W | 100 percentage of participants | |||
| NCT04242446 BE HEARD I | Hidradenitis Suppurativa | Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 Week 16 | BKZ Dosing Regimen 1 | 45.3 percentage of participants |
| BKZ Dosing Regimen 2 | 47.8 percentage of participants | |||
| Placebo | 28.7 percentage of participants | |||
| NCT04242498 BE HEARD II | Hidradenitis Suppurativa | Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 Week 16 | BKZ Dosing Regimen 1 | 53.8 percentage of participants |
| BKZ Dosing Regimen 2 | 52.0 percentage of participants | |||
| Placebo | 32.2 percentage of participants | |||
| NCT05020249 | — | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 Week 16 | Bimekizumab 320 mg Q4W | 81.3 percentage of participants |
| Placebo | 0 percentage of participants | |||
| NCT05020249 | — | Percentage of Participants With an Investigator's Global Assessment (IGA) 0/1 (Clear or Almost Clear With at Least 2-category Improvement From Baseline) Response at Week 16 Week 16 | Bimekizumab 320 mg Q4W | 87.5 percentage of participants |
| Placebo | 0 percentage of participants | |||
| NCT06011733 BE SHINING | Psoriasis | Percentage of Participants With Investigator´s Global Assessment (IGA) 0/1 Response at Week 16 Week 16 | ITP: BKZ Dosage Regimen 1 | 92.0 percentage of participants |
| ITP: Placebo | 3.0 percentage of participants | |||
| NCT06011733 BE SHINING | Psoriasis | Percentage of Participants With Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 Week 16 | ITP: BKZ Dosage Regimen 1 | 94.0 percentage of participants |
| ITP: Placebo | 3.0 percentage of participants |