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

  • STATUS
    Recruiting
  • End date
    Dec 24, 2023
  • participants needed
    700
  • sponsor
    Bio-Thera Solutions
Updated on 24 September 2021
NSAID
arthritis
DMARD
rheumatoid factor
joints tender

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.

Details
Condition Arthritis, Arthritis and Arthritic Pain (Pediatric), Arthritis and Arthritic Pain, PSORIATIC ARTHRITIS, Psoriatic Arthritis, Psoriasis and Psoriatic Disorders, Psoriasis
Treatment BAT2506, EU Simponi
Clinical Study IdentifierNCT05046431
SponsorBio-Thera Solutions
Last Modified on24 September 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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