A Phase 3 Study of Guselkumab in Subjects with Active Psoriatic Arthritis

Phase 1

Conditions: Active Psoriatic Arthritis
MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2016-001163-37-ES

Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 360

Inclusion Criteria

1. Be a man or a woman at least 18 years of age
2. Have a diagnosis of PsA for at least 6 months before the first administration of study agent and meet ClASsification criteria for Psoriatic ARthritis at screening
3. Have active PsA as defined by:
a. At least 3 swollen joints and at least 3 tender joints at screening and at baseline
-AND-
b. C-reactive protein (CRP) =0.3 mg/dL at screening from the central laboratory.
4. Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
5. Have active plaque psoriasis, with at least one psoriatic plaque of =2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis.
6. Have active PsA despite previous non-biologic DMARD, apremilast, and/or NSAID therapy.
- Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 3 months or evidence of intolerance.
- Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 4 months or evidence of intolerance.
- NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance.
7. Subjects may have been previously treated with up to 2 anti-TNFa agents , and must document the reason for discontinuation
a. Lack of benefit to an anti-TNFa therapy, as assessed by the treating physician, after at least 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy and/or at least a 14 week dosage regimen of infliximab. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity.
b. Intolerance to an anti-TNFa biologic therapy, as assessed by the treating physician, to etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab.
c. If no intolerance or lack of benefit, the reason for discontinuation must be documented.
8. If currently using non-biologic DMARDs subjects should have started treatment at least 3 months and the dose must be stable for at least 4 weeks before first administration of study agent and should have no serious toxic side effects attributable to the non-biologic DMARD. If currently not using a MTX, SSZ, or HCQ, must have not received for at least 4 weeks before first administration of study agent.
If currently not using LEF, must not have received for at least 12 weeks before first administration of study agent.
a) If using MTX, the route of administration and dose must be stable and the dose must be =25 mg/week.
b) If receiving SSZ, the dose must be = 3g/day.
c) If receiving HCQ, the dose must be =400 mg/day.
d) If receiving LEF, the dose must be =20 mg/day.
9. If currently using NSAIDs or other analgesics for PsA, subjects must be on a stable dose for at least 2 weeks before first administration of study agent. If currently not using NSAIDs or other analgesics for PsA, must not have received NSAIDs or other analgesics for PsA within 2 weeks before first adminis

Exclusion Criteria

1. Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to RA, axial spondyloarthritis, systemic lupus erythematosus, or
Lyme disease.
2. Has ever received more than 2 anti-TNFa agents.
3. Has received an anti-TNF agent within the following timeframes:
a. Has received infliximab or golimumab within 8 weeks before the first administration of study agent.
b. Has received golimumab SC, adalimumab or certolizumab pegol within 6 weeks before the first administration of study agent.
c. Has received etanercept within 4 weeks before the first administration of study agent.
4. Has previously been treated with guselkumab.
5. Has previously received any biologic treatment (other than anti-TNFa agents), including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment.
6. Has previously received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, or any other Janus kinase inhibitor.
7. Has previously received any systemic immunosuppressants
8. Has received non-biologic DMARDs including, but not limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the first administration of study agent.
9. Is currently receiving 2 or more non-biologic DMARDs at baseline.
10. Has received apremilast within 4 weeks prior to the first administration of study agent.

For a complete overview of the exclusion criteria please refer to protocol section 4.2. (pages 49-52)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate the efficacy of guselkumab treatment in subjects with active PsA by assessing the reduction in signs and symptoms of PsA.;<br> Secondary Objective: - Efficacy in improving psoriatic skin lesions<br> - Improvement in physical function<br> - Efficacy in improving general and disease specific health-related quality of life and patient-reported health outcomes<br> - Safety<br> - Pharmacokinetics, PD, and immunogenicity<br> ;Primary end point(s): The proportion of subjects who achieve an ACR 20 response at Week 24;Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome Measures

Name	Time	Method

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