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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

NCT02963506
2016-001102-42

LINK
LINK

  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
     
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
     
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
     
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
     
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
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
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
Ongoing
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
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
     
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
     
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
     
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
     
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