drugset / Trial / NCT05046431
Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a multicenter, double-blind, randomized, parallel-group study to compare the efficacy,pharmacodynamics (PD), pharmacokinetics (PK), safety, and immunogenicity of BAT2506 versus Simponi® in participants with active PsA. The study will consist of up to 4-week Screening Period, a 52-week Treatment Period, and a 8-week Safety Follow-up Period.
Timeline
- Start
- 2021-05-06
- Primary completion
- 2023-10-06
- Completion
- 2023-10-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAT2506 | Unknown | 50 mg | — |
| Comparator | Golimumab | Monoclonal antibody | 50 mg | — |