Bimekizumab (Bimzelx®)
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| Disease area studied | Abbreviated title | Phase | Study ID | Registry database | Study results | Plain language summary | Publication (if available) |
|---|---|---|---|---|---|---|---|
| Ankylosing Spondylitis | A Multicenter Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis | Phase 2 | AS0008 Completed |
van der Heijde D., Arthritis Rheumatol 2019; 71(Suppl 10), abs 0937 | |||
| Ankylosing Spondylitis | A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis | Phase 2 | AS0009 Ongoing |
NCT03355573 2017-001002-15 |
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| Nonradiographic Axial Spondyloarthritis | A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis | Phase 3 | AS0010 Ongoing |
NCT03928704 2017-003064-13 |
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| Ankylosing Spondylitis | A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis | Phase 3 | AS0011 Ongoing |
NCT03928743 2017-003065-95 |
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| Ankylosing Spondylitis | Study to evaluate the efficacy and safety of Bimekizumab compared to Certolizumab Pegol in the treatment of subjects with active ankylosing spondylitis (AS) | Phase 2 | AS0013 Completed |
NCT03215277 2017-000957-37 |
LINK | ||
| Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis | 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 (BE MOVING) | Phase 3 | AS0014 Ongoing |
NCT04436640 2019-004163-47 |
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| Chronic Plaque Psoriasis | A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis (PSO) | Phase 3 | DV0002 Completed |
NCT03766685 | |||
| Psoriatic Arthritis | The purpose of the study is to evaluate for each self-injecting device presentation the ability of subjects with psoriatic arthritis (PsA) to safely and effectively self-inject bimekizumab at study start and 4 weeks after training in self-injection technique using the bimekizumab safety syringe (SS) or the bimekizumab auto-injector (AI). | Phase 3 | DV0004 Completed |
NCT04109976 | |||
| Chronic Plaque Psoriasis | A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis (PSO) | Phase 3 | DV0006 Completed |
2016-003427-30 | |||
| Hidradenitis Suppurativa | A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa. | Phase 2 | HS0001 Completed |
NCT03248531 2017-000892-10 |
LINK | Jemec G.B.E., Sayed C., Schmieder G., Weisman J., Rolleri R. et al. Experimental Dermatology 2020; 29(Suppl. 1):31–2 9th Conference of the European Hidradenitis Suppurativa Foundation (HS), February 5-7, 2020,; Athens, Greece | |
| Hidradenitis Suppurativa | A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD I) | Phase 3 | HS0003 Ongoing |
NCT04242446 2019-002550-23 |
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| Hidradenitis Suppurativa | A Study to Test the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD II) | Phase 3 | HS0004 Ongoing |
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| Hidradenitis Suppurativa | A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD EXT) | Phase 3 | HS0005 Ongoing |
NCT04901195 2020-004179-42 |
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| Psoriatic Arthritis | A Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Active Psoriatic Arthritis | Phase 2 | PA0008 Completed |
NCT02969525 2016-001103-23 |
LINK LINK |
Ritchlin C.T. et al. The Lancet 2020; 395(10222):427–40 | |
| Psoriatic Arthritis | A Multicenter, Open-Label, Follow-Up Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis | Phase 2 | PA0009 Completed |
NCT03347110 2017-001003-74 |
Merola J., Behrens F., Kivitz A., Mease P., Mcinnes I. et al. Arthritis Rheumatol 2020; 72(S10):- 2020 Annual Meeting of the American College of Rheumatology (ACR) and 2020 Annual Meeting of the Association of Rheumatology Health Professionals (ARHP), November 05-09, 2020; ACR Convergence 2020 Virtual | ||
| Psoriatic Arthritis | A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis | Phase 3 |
PA0010 |
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| Psoriatic Arthritis | A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis | Phase 3 | PA0011 Ongoing |
NCT03896581 2017-002804-29 |
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| Psoriatic Arthritis | A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis | Phase 3 | PA0012 Ongoing |
NCT04009499 2018-004725-86 |
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| Chronic Plaque Psoriasis | A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis | Phase 3 | PS0008 Completed |
NCT03412747 2016-003392-22 |
LINK | Warren R.B. et al. N Engl J Med 2021;385(2):130-41 | |
| Chronic Plaque Psoriasis | A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis | Phase 3 | PS0009 Completed |
NCT03370133 2016-003425-42 |
LINK | Reich K. et al. Lancet 2021; 397(10273):487–98 | |
| Chronic Plaque Psoriasis | Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients with Chronic Plaque Psoriasis | Phase 2 | PS0010 Completed |
NCT02905006 2016-001891-31 |
LINK LINK |
Papp K.A., et al. J Am Acad Dermatol 2018; 79(2):277–286 | |
| Chronic Plaque Psoriasis | A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis | Phase 2 | PS0011 Completed |
NCT03010527 2016-001892-57 |
Blauvelt, A. et al. Ann Rheum Dis 2019; 78 (Suppl. 2), s. 1834 | ||
| Chronic Plaque Psoriasis | A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis | Phase 3 | PS0013 Completed |
NCT03410992 2016-003426-16 |
LINK | Gordon K.B., Foley P., Krueger J.G., Pinter A., Reich K. et al. Lancet 2021; 397(10273):475–86 | |
| Chronic Plaque Psoriasis | A Study to Assess the Safety, Tolerability and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis | Phase 3 | PS0014 Ongoing |
NCT03598790 2016-003427-30 |
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| Chronic Plaque Psoriasis | A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis | Phase 3 | PS0015 Ongoing |
NCT03536884 2017-003784-35 |
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| Chronic Plaque Psoriasis | A Multicenter, Randomized, Subject-Blind, Investigator-Blind Study to Evaluate the Time Course of Pharmacodynamic Response, Safety and Pharmacokinetics of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis | Phase 2 | PS0016 Completed |
NCT03025542 2016-002368-15 |
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| Chronic Plaque Psoriasis | A Multicenter, 48-week, Open-label Extension Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis | Phase 2 | PS0018 Completed |
NCT03230292 2016-002934-57 |
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| Plaque Psoriasis | A Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis (BE CONNECTED) | Phase 2 | PS0020 Ongoing |
NCT04718896 2020-001724-34 |
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| Moderate to Severe Plaque Psoriasis | A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis | Phase 3 | PS0032 Ongoing |
NCT05020249 | |||
| Rheumatoid arthritis | Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis | Phase 2 | RA0123 Completed |
NCT02430909 2014-003307-30 |
LINK | Glatt et al. Annals of the rheumatic diseases 2019 [ePub] | |
| Ulcerative Colitis | A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body. |
Phase 2 | UC0011 Terminated |
2016-000420-26 | LINK |