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 Baraliakos X.,et al. Therapeutic Advances in Musculoskeletal 2024; 16:1–8 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 Bagel J., et al. JDD 2022; 21(2):162–71 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 Bagel J., et al. JDD 2022; 21(2):162–71 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 LINKLINK 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 LINKLINK 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 Orenstein, L. A. V. et al. J Deutsche Dermatologie Gesellschaft 2025; 23 (Suppl 3), 133 Deutsche Dermatologische Gesellschaft (DDG), April 30-May 3, 2025; Berlin, Germany [In German] Zouboulis, C. et al. J Deutsche Dermatologie Gesellschaft 2025; 23 (Suppl 3), 129–130 Deutsche Dermatologische Gesellschaft (DDG), April 30-May 3, 2025; Berlin, Germany [In German] Zouboulis, C. et al. J Deutsche Dermatologie Gesellschaft 2025; 23 (Suppl 3), 132–133 Deutsche Dermatologische Gesellschaft (DDG), April 30-May 3, 2025; Berlin, Germany [In German] Hidradenitis Suppurativa A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa Phase 3 HS0006 Ongoing NCT06921850 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 LINKLINK 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 Completed 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 Youn S.W., et al. J Dermatol 2024; 51(11):1392–403 Moderate to Severe Plaque Psoriasis A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis (BE UNIQUE) Phase 3 PS0039 Ongoing NCT065069162023-506333-29-00 Gudjonsson, J. E. et al. The British journal of dermatology 2024; 191 (suppl.3), iii54-iii55 Psoriasis: From Gene to Clinic (PGC) 2024 – 10th International Congress; December 5–7, 2024; London, UK Plaque Psoriasis A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis Phase 3 PS0041 Completed 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 Sebastian, M. et al. Dermatology and therapy 2025; 15 (5): 1113–1134 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 Merola J.F.et al.Ann Rheum Dis 2025; 84(Supplement 1):1865–6 EULAR European Congress of Rheumatology (EULAR), June 11-14, 2025; Barcelona, Spain Ankylosing Spondylitis and Psoriatic Arthritis An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Phase 3 JA0005 Ongoing N/A A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab) (BE CARING) Phase 1 UP0122 Ongoing NCT06888193
