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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EU Simponi | Active Comparator |
| |
| BAT2506 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAT2506 | Drug | 50mg/0.5mL |
| |
| EU Simponi |
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 | To demonstrate the equivalence of BAT2506 and Simponi® on ACR 20 response in participants with active PsA | Week 8 for EMA or Week 14 for FDA and NMPA |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital Sichuan University | Chengdu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42021476 | Derived | Tang H, Dokoupilova E, Batko B, Zawadzki M, Batalov A, Liu Y, Yang X, Zhou Y, Dong Q, Liu Y. Comparing the efficacy and safety of biosimilar BAT2506 with reference golimumab in patients with active psoriatic arthritis: 24-week results of a phase 3, multicenter, double-blind, randomized, parallel-group study. Expert Opin Biol Ther. 2026 May;26(5):515-524. doi: 10.1080/14712598.2026.2663826. Epub 2026 Apr 28. |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| Drug |
50mg/0.5mL |
|
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |