At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Confirmed PsA diagnosis per CASPAR criteria with ≥6 months symptom duration
- ✓Active disease with TJC68 ≥3 and SJC66 ≥3
- ✓Current active plaque psoriasis or dermatologist-confirmed history of plaque psoriasis
- ✕Known hypersensitivity to sonelokimab or its excipients
- ✕Known hypersensitivity or contraindication to risankizumab or its excipients
- ✕Other chronic inflammatory conditions besides psoriasis or PsA
- ✕Inflammatory bowel disease diagnosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Parallel-group, Randomized, Double-blind, 4-arm, Placebo-controlled, Multicenter Study With Risankizumab as Active Reference Arm, to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors
In Brief
A Phase 3 clinical trial evaluating Sonelokimab, Placebo, and 1 other intervention for Arthritis, Psoriatic. Currently recruiting, targeting 600 participants across 138 sites in 11 countries.
Signals
Detailed Summary
This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.
Study Details
Timeline
Arms & Interventions
Subjects randomized to this arm will receive sonelokimab dose 1 subcutaneously (SC) as an induction regimen of 4 doses , followed by sonelokimab SC every 4 weeks (Q4W) maintenance dosing starting at Week 8.
Subjects randomized to this arm will receive sonelokimab dose 2 SC as an induction regimen of 4 doses, followed by sonelokimab SC Q4W maintenance dosing starting at Week 8.
Subjects randomized to this arm will receive placebo SC
Subjects randomized to this arm will receive risankizumab SC
Interventions
Sonelokimab
Placebo
Active comparator