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

Psoriatic Arthritis Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized, Parallel-group Study to Compare the Efficacy and Safety of BAT2506 Versus Simponi® in Participants With Active Psoriatic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05046431
• Other study ID #: BAT-2506-002-CR
• Status: Completed
• Phase: Phase 3
• Start date: May 6, 2021
• Est. completion date: October 6, 2023

Study information

• Verified date: October 2023
• Source: Bio-Thera Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 704
• Est. completion date: October 6, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• BAT2506
50mg/0.5mL
• EU Simponi
50mg/0.5mL

Locations

Country	Name	City	State
China	West China Hospital Sichuan University	Chengdu

Sponsors (1)

Lead Sponsor	Collaborator
Bio-Thera Solutions

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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