Clinical trial NCT05046431: Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Lead sponsor: Bio-Thera Solutions
Sponsor class: INDUSTRY
First posted: 2021-09-16
Enrollment: 704
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: ACR20
timeFrame: Week 8 for EMA or Week 14 for FDA and NMPA
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital Sichuan University
Study officials:
References: