drugset / Trial / NCT04242446
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)
Timeline
- Start
- 2020-02-19
- Primary completion
- 2022-04-07
- Completion
- 2023-02-19
Outcome
Met primary endpoint
paper The primary outcome at week 16 was met in the group who received bimekizumab every 2 weeks using modified non-responder imputation; PMID 38795716 ↗
registry analysis (superiority test); Placebo vs BKZ Dosing Regimen 1; p = 0.030; Odds Ratio (OR) 2.000 (97.5% CI 0.979 to 4.089); Regression, Logistic NCT04242446 ↗
release “Top-line results show that the two Phase 3 studies, BE HEARD I and BE HEARD II, met their primary and key secondary endpoints with statistical” ucb.com ↗
release “achieved HiSCR50, the primary endpoint, at week 16 vs. placebo in BE HEARD I and BE HEARD II” ucb.com ↗
Publications
- Results Kirby JS, Thorlacius L, Lambert J, Ciaravino V, Rolleri R, Pansar I, Muller E, Pelligra CG, Ingram JR. Psychometric validation and interpretation thresholds of the Hidradenitis Suppurativa Quality of Life (HiSQOL(c)) questionnaire using pooled data from the phase III BE HEARD I & II trials of bimekizumab in hidradenitis suppurativa. Br J Dermatol. 2025 Jun 20;193(1):93-104. doi: 10.1093/bjd/ljaf067.
- Results Ingram JR, Lambert J, Ciaravino V, Rolleri R, Pansar I, Peterson L, Pelligra CG, Thorlacius L. Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) and Questionnaire (HSSQ): Psychometric Validation and Interpretation Threshold Derivation Using Phase 3 Study Data. Dermatol Ther (Heidelb). 2025 May;15(5):1093-1111. doi: 10.1007/s13555-025-01346-w. Epub 2025 Mar 28.
- Results Shi VY, Ingram JR, Lev-Tov H, Schneider-Burrus S, Forman S, Porter ML, Hayama K, Thorlacius L, Lambert J, Vaux T, Lukowski B, Rolleri RL, Szepietowski JC. Bimekizumab Impact on Patient-Reported Outcomes in Patients with Moderate to Severe Hidradenitis Suppurativa: Pooled 48-Week Results from BE HEARD I&II. Dermatol Ther (Heidelb). 2025 Sep;15(9):2553-2570. doi: 10.1007/s13555-025-01465-4. Epub 2025 Jul 13.
- Results Ingram JR, Fujita H, Gottlieb AB, Lev-Tov H, Prens E, Sayed CJ, Shi VY, Szepietowski JC, Takahashi K, Frew JW, Lambert J, Davis L, Oh T, Rolleri R, Saintmard MH, Orenstein LAV. Bimekizumab Pain Outcomes in Patients with Hidradenitis Suppurativa: Pooled 48-Week Results from BE HEARD I&II Phase 3 Randomized Clinical Trials. Pain Ther. 2025 Dec;14(6):1861-1878. doi: 10.1007/s40122-025-00779-7. Epub 2025 Oct 17.
- Results Tzellos T, Giamarellos-Bourboulis EJ, van Straalen KR, Martorell A, Kirby B, Alavi A, Hayama K, Khattri S, Gulliver W, Sayed CJ, Davis L, Rolleri RL, Crater C, Pansar I, Lambert J, Zouboulis CC. Bimekizumab efficacy using IHS4 outcomes in hidradenitis suppurativa: Results from BE HEARD I and II. J Eur Acad Dermatol Venereol. 2026 Feb 14. doi: 10.1111/jdv.70356. Online ahead of print.
- Results Sayed CJ, Kirby B, Garg A, Naik HB, Kimball AB, Zouboulis CC, Jemec GBE, Kokolakis G, Ingram JR, Morita A, Deherder D, Crater C, Rolleri RL, Vaux T, Lambert J, Lukowski B, Bechara FG. Bimekizumab demonstrated a favorable safety profile and high levels of efficacy with up to 2 years of treatment in patients with moderate to severe hidradenitis suppurativa: Pooled results from two phase 3 randomized, controlled trials and their open-label extension. J Am Acad Dermatol. 2026 Mar;94(3):867-878. doi: 10.1016/j.jaad.2025.11.031. Epub 2025 Nov 15.
- Results Aleshin MA, Tran T, Pansar I, Shang A, Friesen D, Kimball AB. Residual Burden in Adalimumab-Treated Patients with Hidradenitis Suppurativa: An Observational Cohort Study Based on Insurance Claims in the USA. Drugs Real World Outcomes. 2026 Jul 29. doi: 10.1007/s40801-026-00564-8. Online ahead of print.
- Daveluy S, Gottlieb AB, Augustin M, Lev-Tov H, Szepietowski JC, Horvath B, Porter ML, Hayama K, Lambert J, Tilt N, Lukowski B, Thorlacius L. Association Between Bimekizumab's Clinical Response and Patient-Reported Benefits on Health-Related Quality of Life: Results from BE HEARD I and II. Dermatol Ther (Heidelb). 2026 Jul;16(7):3315-3329. doi: 10.1007/s13555-026-01790-2. Epub 2026 Jun 5.
- Kimball AB, Jemec GBE, Sayed CJ, Kirby JS, Prens E, Ingram JR, Garg A, Gottlieb AB, Szepietowski JC, Bechara FG, Giamarellos-Bourboulis EJ, Fujita H, Rolleri R, Joshi P, Dokhe P, Muller E, Peterson L, Madden C, Bari M, Zouboulis CC. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials. Lancet. 2024 Jun 8;403(10443):2504-2519. doi: 10.1016/S0140-6736(24)00101-6. Epub 2024 May 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bimekizumab | Monoclonal antibody | 320 mg | Subcutaneous |