Trials / Completed
CompletedNCT05046431
Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis
A Multicenter, Double-blind, Randomized, Parallel-group Study to Compare the Efficacy and Safety of BAT2506 Versus Simponi® in Participants With Active Psoriatic Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 704 (actual)
- Sponsor
- Bio-Thera Solutions · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BAT2506 | 50mg/0.5mL |
| DRUG | EU Simponi | 50mg/0.5mL |
Timeline
- Start date
- 2021-05-06
- Primary completion
- 2023-10-06
- Completion
- 2023-10-06
- First posted
- 2021-09-16
- Last updated
- 2023-10-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05046431. Inclusion in this directory is not an endorsement.