Bimekizumab (Bimzelx®)
| Disease area studied | Abbreviated title | Phase | Study ID | Registry database | Study results | Plain language summary | Publication (if available) |
|---|---|---|---|---|---|---|---|
| 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 LINK |
"Glatt S., Jemec G.B.E., Forman S., Sayed C., Schmieder G. et al. JAMA Dermatol 2021; 157(11):1279–88 " | |
| 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 |
NCT03355573 2017-001002-15 |
Baraliakos X., Deodhar A., Dougados M., Gensler L.S., Molto A. et al. Arthritis Rheumatol. 2022; 74(12):1943–58 | ||
| 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 |
LINK LINK |
Blauvelt, A. et al. Ann Rheum Dis 2019; 78 (Suppl. 2), s. 1834 | |
| Nonradiographic Axial Spondyloarthritis | A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis | Phase 3 |
AS0010
Completed |
NCT03928704 2017-003064-13 |
Deodhar A., et al. Ann Rheum Dis 2022; 81(Suppl 1):772–3, abs POS0939 | ||
| 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. Ann Rheum Dis 2019; 78(8):1033-1040 | |
| 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 |
LINK LINK |
Glatt S. et al., Ann Rheum Dis 2019; 78(8):1033-1040 | |
| 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 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 LINK |
Gordon, K.B.; Langley, R.G.; Warren, R.B.; Okubo, Y.; Stein Gold, L.; Merola, J.F. et al. 2022 JAMA Dermatol 158(7):735–44 | |
| 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 |
NCT03895203 2017-002322-20 |
LINK
|
McInnes I.B., et al. Lancet 2023; 401(10370):25-37 Ritchlin C.T., et al. Ann Rheum Dis 2023; 82(11):1404–14 | |
| 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 |
LINK
|
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 Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis | Phase 3 |
PA0011
Completed |
NCT03896581 2017-002804-29 |
LINK
|
Merola J.F., et al.Lancet 2023; 401(10370):38-48 | |
| 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 LINK |
Oliver R., Krueger J.G., Glatt S., Vajjah P., Mistry C. et al. Br J Dermatol 2022; 186:652–63 | |
| 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 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 LINK |
Reich K. et al. Lancet 2021; 397(10273):487–98 Asahina A.. et al. Dermatol Ther (Heidelb) 2023; 13(3):751–68 | |
| 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 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 |
NCT03536884 2017-003784-35 |
LINK
|
Strober B., et al. J Am Acad Dermatol 2023;89(3): 486-495 | |
| 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 |
NCT03598790 2016-003427-30 |
Thaçi D. et al. Br J Dermatol 2023; 188(1):22–31 | ||
| 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 Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis | Phase 3 |
AS0011
Completed |
NCT03928743 2017-003065-95 |
van der Heijde D., et al. Ann Rheum Dis 2022; 81(Suppl 1):12–3, abs OP0019 | ||
| 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 LINK |
Warren R.B. et al. N Engl J Med 2021;385(2):130-41 | |
| 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 |
LINK
|
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| 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 Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD I) | Phase 3 |
HS0003
Completed |
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
Completed |
NCT04242498 2019-002551-42 |
LINK
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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 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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| 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 |
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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
Completed |
NCT05020249 | |||
| 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
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| 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 |