drugset / Trial / NCT04728360
Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is a multicenter, randomized, double-blind, parallel-arm, Phase 3 study designed to compare efficacy, safety, immunogenicity, and PK of BAT2206 with Stelara in patients with moderate to severe plaque psoriasis. The study is composed of a ≤ 28-day screening period, a 16-week initial treatment period (TP1), a 24-week secondary treatment period (TP2), a 12-week efficacy and safety follow-up period up to end-of-study visit, for a maximum total study duration of 56 weeks.
Timeline
- Start
- 2021-07-06
- Primary completion
- 2022-10-12
- Completion
- 2023-07-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAT2206 | Unknown | 45 mg | Subcutaneous |
| Comparator | Ustekinumab | Monoclonal antibody | 45 mg | Subcutaneous |
| Comparator | Ustekinumab | Monoclonal antibody | 90 mg | Subcutaneous |