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 NCT029635062016-001102-42 LINKLINK Baraliakos X., et al. Arthritis Rheumatol. 2022; 74(12):1943–58 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 Completed NCT033555732017-001002-15 LINKLINK Baraliakos X., et al. Arthritis Rheumatol. 2022; 74(12):1943–58 Nonradiographic Axial Spondyloarthritis A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis Phase 3 AS0010 Completed NCT039287042017-003064-13 PDF van der Heijde D., et al. Ann Rheum Dis 2023; 82:515–26 Ankylosing Spondylitis A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis Phase 3 AS0011 Completed NCT039287432017-003065-95 LINKLINK PDF van der Heijde D., et al. Ann Rheum Dis 2023; 82:515–26 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 NCT032152772017-000957-37 LINKLINK Mease, P. et al. Ann Rheum Dis 2024; 83 (Suppl 1), 1742–1743 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 NCT044366402019-004163-472023-506527-28-00 Mease, P. et al. Ann Rheum Dis 2024; 83 (Suppl 1), 1742–1743 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 LINK 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 LINK Kivitz A., et al. Patient Prefer Adherencee 2023; 17:2451–61 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 NCT032485312017-000892-10 LINKLINK Glatt S., et al. JAMA Dermatol 2021; 157(11):1279–88 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 Completed NCT042424462019-002550-23 LINK PDF Kimball A.B., et al. Lancet 2024; 403(10443):2504–2519 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 Completed NCT042424982019-002551-42 LINK PDF Kimball A.B., et al. Lancet 2024; 403(10443):2504–2519 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 NCT049011952020-004179-422024-511035-10-00 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 NCT029695252016-001103-23 LINKLINK 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 NCT033471102017-001003-74 LINKLINK Mease P.J., et al. Rheumatology (Oxford) 2023; 62(2):617–28 Psoriatic Arthritis A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis Phase 3 PA0010 Completed NCT038952032017-002322-20 LINKLINK PDF McInnes I.B., et al. Lancet 2023; 401(10370):25-37 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 NCT038965812017-002804-29 LINKLINK PDF Merola J.F., et al. Lancet 2023; 401(10370):38-48 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 NCT040094992018-004725-862023-506528-95-00 Coates, Laura C. et al. RMD open 2024; 10(1), e003855 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 NCT034127472016-003392-22 LINKLINK PDF 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 NCT033701332016-003425-42 LINKLINK PDF Reich K., et al. Lancet 2021; 397(10273):487–98 Asahina A., et al. Dermatol Ther (Heidelb) 2023; 13(3):751–68 Chronic Plaque Psoriasis Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis Phase 2 PS0010 Completed NCT029050062016-001891-31 LINKLINK 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 NCT030105272016-001892-57 LINKLINK Blauvelt A., et al. J Am Acad Dermatol 2020; 83(5):1367–74 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 NCT034109922016-003426-16 LINK PDF Gordon K.B., 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 Completed NCT035987902016-003427-30 LINK PDF Thaçi D., et al. Br J Dermatol 2023; 188(1):22–31 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 Completed NCT035368842017-003784-35 LINKLINK PDF Strober B., et al. J Am Acad Dermatol 2023;89(3): 486-495 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 NCT030255422016-002368-15 LINKLINK Oliver R., et al. Br J Dermatol 2022; 186:652–63 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 NCT032302922016-002934-57 LINKLINK Blauvelt A., et al. J Am Acad Dermatol 2024; 91(1):72–81 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 NCT047188962020-001724-342023-509832-24-00 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 Completed NCT05020249 LINK PDF Plaque Psoriasis A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis PS0041 Ongoing NCT06011733 Rheumatoid Arthritis Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis Phase 2 RA0123 Completed NCT024309092014-003307-30 LINK Glatt S., et al. Ann Rheum Dis 2019; 78(8):1033-1040 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 Plaque Psoriasis A Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants Phase 1 UP0119 Completed NCT05292131 PDF Plaque Psoriasis A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis (BE TOGETHER) Phase 3 PS0021 Ongoing NCT064255492023-503859-10-00 Psoriatic Arthritis A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis Phase 3 PA0016 Ongoing NCT066242282024-511738-11-00
