A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Summary

This is a study to evaluate the long-term safety and tolerability of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis (PSO).

Timeline

Start

2018-09-05

Primary completion

2023-11-14

Completion

2023-11-14

Publications

• Results Gordon KB, Langley RG, Warren RB, Okubo Y, Stein Gold L, Merola JF, Peterson L, Wixted K, Cross N, Deherder D, Thaci D. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185.
• Results Thaci D, Vender R, de Rie MA, Conrad C, Pariser DM, Strober B, Vanvoorden V, Wang M, Madden C, de Cuyper D, Kimball AB. Safety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial. Br J Dermatol. 2023 Jan 23;188(1):22-31. doi: 10.1093/bjd/ljac021.
• Results Gordon KB, Langley RG, Warren RB, Okubo Y, Rosmarin D, Lebwohl M, Peterson L, Madden C, de Cuyper D, Davies O, Thaci D. Bimekizumab safety in patients with moderate-to-severe plaque psoriasis: pooled data from up to 3 years of treatment in randomized phase III trials. Br J Dermatol. 2024 Mar 15;190(4):477-485. doi: 10.1093/bjd/ljad429.
• Results Lebwohl M, Merola JF, Strober B, Armstrong A, Yoshizaki A, Gisondi P, Szilagyi B, Peterson L, de Cuyper D, Cross N, Davies O, Gottlieb AB. Bimekizumab safety in moderate to severe plaque psoriasis: Rates of hepatic events and changes in liver parameters over 2 years in randomized phase 3/3b trials. J Am Acad Dermatol. 2024 Aug;91(2):281-289. doi: 10.1016/j.jaad.2024.03.041. Epub 2024 Apr 6.
• Results Merola JF, Gottlieb AB, Pinter A, Elewski B, Gooderham M, Warren RB, Piaserico S, Wixted K, Cross N, Tilt N, Wiegratz S, Mrowietz U. Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials. Dermatol Ther (Heidelb). 2024 Dec;14(12):3291-3306. doi: 10.1007/s13555-024-01295-w. Epub 2024 Nov 22.
• Results Okubo Y, Tada Y, Takahashi H, Abe M, Yamanaka K, Tilt N, Cross N, Deherder D, Matano M, Nakagawa H. Efficacy and Safety of Bimekizumab in Japanese Patients with Generalised Pustular Psoriasis and Erythrodermic Psoriasis: 3-Year Results from BE BRIGHT, a Multicentre, Open-Label, Phase 3 Study. Dermatol Ther (Heidelb). 2025 Oct;15(10):2947-2966. doi: 10.1007/s13555-025-01509-9. Epub 2025 Aug 11.
• Results Strober B, Boehncke WH, Krueger JG, Magnolo N, Vender R, Warren RB, Lopez Pinto JM, Kavanagh S, Hoepken B, Gisondi P. Bimekizumab Efficacy in Psoriasis by Subgroups: Post Hoc Analysis of Phase 3/3b Clinical Trials. Dermatol Ther (Heidelb). 2025 Dec;15(12):3633-3650. doi: 10.1007/s13555-025-01557-1. Epub 2025 Oct 8.
• Results Armstrong A, Papp KA, Lebwohl M, Savage LJ, Yamanaka K, Vlase DE, Warham R, Lambert J, Lopez Pinto JM, Wixted K, Thaci D. Bimekizumab Impact on Patient-Reported Outcomes in Plaque Psoriasis: 4-Year Results from BE SURE, BE VIVID, BE READY, and BE BRIGHT. Dermatol Ther (Heidelb). 2026 Jan;16(1):585-603. doi: 10.1007/s13555-025-01595-9. Epub 2025 Dec 8.
• Results Krueger JG, Cutcutache I, Lebwohl M, Gudjonsson JE, Pinter A, Langley RG, Merola J, Tada Y, Skelton A, Rastrick J, Ferecsko AS, Page M, Davies O, Lopez Pinto JM, Warham R, Shaw S, Warren RB. Bimekizumab long-term response in psoriasis: Mechanistic insights into efficacy level and durability. J Allergy Clin Immunol. 2026 Apr;157(4):905-916. doi: 10.1016/j.jaci.2025.12.1013. Epub 2026 Jan 22.
• Results Gisondi P, Elewski B, Pinter A, Yamaguchi Y, Gooderham M, Kavanagh S, Wixted K, Cross N, Szilagyi B, Merola JF. Bimekizumab efficacy in scalp, nail and palmoplantar psoriasis versus comparators and over 4 years. J Dermatolog Treat. 2026 Dec;37(1):2637344. doi: 10.1080/09546634.2026.2637344. Epub 2026 Mar 9.
• Merola JF, Warren RB, Thaci D, Gordon KB, Nishida E, Strober B, Conrad C, Kavanagh S, Lopez Pinto JM, Hoepken B, Gisondi P. Bimekizumab Complete Clearance of Both Skin and Nail Psoriasis: Comparative Efficacy in Phase III/IIIb Studies. Am J Clin Dermatol. 2025 Nov;26(6):967-979. doi: 10.1007/s40257-025-00968-2. Epub 2025 Aug 31.
• Blauvelt A, Langley RG, Lebwohl M, Strober B, Warren RB, Puig L, Morita A, Gordon KB, Fernandez-Penas P, Kavanagh S, Lopez Pinto JM, Lambert J, Hoepken B, Deherder D, Cross N, Thaci D. Bimekizumab durability of efficacy through 196 weeks and safety through 4 years in patients with moderate to severe plaque psoriasis: Results from the BE BRIGHT open-label extension trial. J Am Acad Dermatol. 2025 Sep;93(3):644-653. doi: 10.1016/j.jaad.2025.04.038. Epub 2025 Apr 24.
• Kokolakis G, Warren RB, Strober B, Blauvelt A, Puig L, Morita A, Gooderham M, Korber A, Vanvoorden V, Wang M, de Cuyper D, Madden C, Nunez Gomez N, Lebwohl M. Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials. Br J Dermatol. 2023 Feb 22;188(3):330-340. doi: 10.1093/bjd/ljac089.

Drugs

Indications