Guselkumab versus Placebo for the Treatment of Psoriatic Arthritis Axial Disease in Bio-naive Participants

Phase 1

• Conditions: Psoriatic Arthritis; MedDRA version: 21.0Level: LLTClassification code: 10037160Term: Psoriatic arthritis Class: 10028395; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-504716-15-00
• Lead Sponsor: Janssen - Cilag International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-28
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 408

Inclusion Criteria

1. Be at least 18 years of age, 2. Have a diagnosis of PsA for at least 6 months prior to the first administration of study intervention and meet ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria at screening., 3. Have active PsA as defined by: At least 3 swollen joints and at least 3 tender joints at screening and at baseline and C-reactive protein =0.3 mg/dL at screening from the central laboratory., 4. Have a BASDAI score of at least 4., 5. Have magnetic resonance imaging-confirmed PsA axial disease, 6. Have a spinal pain score of at least 4., 7. Have active plaque psoriasis, with at least one psoriatic plaque of =2 cm diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis., 8. Have active PsA despite previous non-biologic DMARD, apremilast, and/or NSAID therapy.

Exclusion Criteria

1. Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis, ankylosing spondylitis/non-radiographic-axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease., 10. Has or has had a serious infection or has been hospitalized or received IV antibiotics for an infection within 2 months prior to screening., 2. Has previously received any biologic treatment including, but not limited to, guselkumab, ustekinumab, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab or other investigative biologic treatment., 3. Has ever received a Janus kinase inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor., 4. Has received any systemic immunosuppressants within 4 weeks of the first administration of study intervention., 5. Has received apremilast within 4 weeks prior to the first administration of study intervention., 6. Has received non-biologic DMARDs other than MTX, SSZ, HCQ, LEF, within 4 weeks before the first administration of study intervention., 7. Currently has a malignancy or has a history of malignancy within 5 years prior to screening, 8. Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly., 9. Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection, recurrent urinary tract infection fungal infection, or open, draining, or infected skin wounds or ulcers.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified