Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis

Phase 3

Completed

• Conditions: Psoriatic Arthritis
• Interventions: Drug: EU Simponi; Drug: BAT2506

• Registration Number: NCT05046431
• Lead Sponsor: Bio-Thera Solutions

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-06
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-16
• Status Verified: 2023-10
• Primary Completion: 2023-10-06
• Study Completion: 2023-10-06
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 704

Inclusion Criteria

• Participant has PsA for at least 6 months prior to the first administration of the study drug and meets classification criteria for PsA (CASPAR) at Screening.
• Participant has active PsA defined by the presence of ≥3 of 68 tender joint counts and ≥3 of 66 swollen joint counts at Screening and Randomization.
• Participant has active PsA at Screening despite previous DMARD or NSAID therapy. DMARD therapy is defined as taking DMARD for at least 3 months, or evidence of DMARD intolerance. NSAID therapy is defined as taking an NSAID for at least 4 weeks (or have intolerance to or contraindication to NSAID therapy).
• Participant has at least 1 active psoriatic lesion with a qualifying lesion of at least 2 cm in diameter at Screening and Randomization.
• Participant is negative for rheumatoid factor and anti-cyclic citrullinated peptide (ACCP) antibodies at Screening.

Exclusion Criteria

• Participant is currently receiving or has previously received any biological agent or targeted disease modifying anti-rheumatic drugs (DMARDs) for the treatment of PsA or psoriasis.
• Participant has previously received any other nonbiological DMARDs (apart from MTX), including sulfasalazine, hydroxychloroquine or apremilast within 8 weeks prior to the first administration of the study drug; or has previously received leflunomide within 12 weeks (except at least 4 weeks prior to the first administration of the study drug, the subject has documented completion of standard cholestyramine or activated charcoal washout procedure).
• Participant has received epidural, intra-articular, intramuscular, or intravenous (IV) corticosteroids during the 4 weeks prior to first administration of study drug.
• Participant has been treated with cytotoxic agents, (including but not limited to azathioprine, cyclosporine, cyclophosphamide), nitrogen mustard, chlorambucil, or other alkylating agents within 6 months prior to the first administration of the study drug.
• Participant has received or is expected to receive any live vaccinations from 3 months before first study drug administration and up to 3 months after the last study drug administration.
• Participant has received other therapeutic infectious agents within 8 weeks prior to first dose or expected to receive other therapeutic infectious agents during the study until SFU.
• Participant has received IV immunoglobulins or plasmapheresis within 6 months prior to the first administration of the study drug.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EU Simponi	EU Simponi	-
BAT2506	BAT2506	-

Primary Outcome Measures

Name	Time	Method
ACR20	Week 8 for EMA or Week 14 for FDA and NMPA	To demonstrate the equivalence of BAT2506 and Simponi® on ACR 20 response in participants with active PsA

Trial Locations

Locations (1)

West China Hospital Sichuan University; 🇨🇳 Chengdu, China