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

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.

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Drug: EU Simponi; Drug: BAT2506

• Study Type: Interventional
• Enrollment (Actual): 704
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Chengdu, China
    • West China Hospital Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EU Simponi	Drug: EU Simponi; 50mg/0.5mL
Experimental: BAT2506	Drug: BAT2506; 50mg/0.5mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Bio-Thera Solutions

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Actual): October 6, 2023
• Study Completion (Actual): October 6, 2023

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Tumor Necrosis Factor Inhibitors; Golimumab
• Other Study ID Numbers: BAT-2506-002-CR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No