drugset / Trial / NCT05335356
Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a randomized, double-blind, active-controlled, parallel-group, multicenter study designed to compare the efficacy, safety, immunogenicity, and PK(Pharmacokinetic) of Bmab 1200 with Stelara in adult patients with moderate to severe chronic plaque psoriasis.
Timeline
- Start
- 2022-06-28
- Primary completion
- 2023-01-26
- Completion
- 2023-11-15
Outcome
Met primary endpoint
paper the least squares mean treatment difference (0.6800%; 90% CI: -1.27, 2.63; 95% CI: -1.64, 3.00) was within the predefined equivalence margins PMID 40708530 ↗
Publications
- Szepietowski JC, Reich A, Feldman SR, Pulka G, Mekokishvili L, Tsiskarishvili N, Svarca I, Poder A, Singh G, Deodhar S, Kumar K, Marwah A, Loganathan S, Wolff-Holz E, Athalye SN. Comparative efficacy and safety of biosimilar Bmab 1200 versus reference ustekinumab in moderate-to-severe plaque psoriasis: 52-week findings from the Phase 3 STELLAR-2 trial. Expert Opin Biol Ther. 2025 Oct;25(10):1121-1133. doi: 10.1080/14712598.2025.2576506. Epub 2025 Oct 21.
- Szepietowski JC, Reich A, Feldman SR, Pulka G, Mekokishvili L, Tsiskarishvili N, Svarca I, Poder A, Singh G, Deodhar S, Kumar K, Marwah A, Loganathan S, Athalye SN, Wolff-Holz E. Efficacy and safety of the ustekinumab biosimilar, Bmab 1200, versus reference ustekinumab in moderate-to-severe plaque psoriasis: 28-week results of the randomized, double-blind, Phase 3 STELLAR-2 study. Expert Opin Biol Ther. 2025 Aug;25(8):913-924. doi: 10.1080/14712598.2025.2538608. Epub 2025 Jul 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bmab 1200 | Unknown | 45 mg | — |
| Subject | Bmab 1200 | Unknown | 90 mg | — |
| Comparator | Ustekinumab | Monoclonal antibody | 45 mg | — |
| Comparator | Ustekinumab | Monoclonal antibody | 90 mg | — |