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Bimekizumab (Bimzelx®)

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
NCT02963506
2016-001102-42
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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
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
Deodhar A., et al. Ann Rheum Dis 2022; 81(Suppl 1):772–3, abs POS0939
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
van der Heijde D., et al. Ann Rheum Dis 2022; 81(Suppl 1):12–3, abs OP0019
Ankylosing Spondylitis. A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis Phase 2 AS0013
Completed
NCT03215277
2017-000957-37
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Glatt S. et al., Ann Rheum Dis 2019; 78(8):1033-1040
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
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
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"Glatt S., Jemec G.B.E., Forman S., Sayed C., Schmieder G. et al. JAMA Dermatol 2021 [ePub] "
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
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
NCT04242498
2019-002551-42
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
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
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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
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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
Ongoing
NCT03895203
2017-002322-20
Psoriatic Arthritis A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis Phase 3 PA0011
Completed
NCT03896581
2017-002804-29
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
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
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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
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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
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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
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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
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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
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
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
LINK
Oliver R., Krueger J.G., Glatt S., Vajjah P., Mistry C. et al. Br J Dermatol 2021 [ePub]
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
LINK
Gordon, K.B.; Langley, R.G.; Warren, R.B.; Okubo, Y.; Stein Gold, L.; Merola, J.F. et al. 2022 JAMA Dermatol (aheadofprint)
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 Phase 2 PS0020
Ongoing
NCT04718896
2020-001724-34
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