Ireland
--:--IST
Active, not recruiting Phase 3

Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response

NCT06641089 · tracked via the Priya Life Science UK tracker
Phase
Phase 3
Started
2024-10-15
Last updated
2026-10-09

Condition(s) studied

Arthritis, Psoriatic

Investigational drug(s) / intervention(s)

Sonelokimab →PlaceboRisankizumab →

Sonelokimab: Sonelokimab

Placebo: Placebo

Risankizumab: Active comparator

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Participants must be ≥18 years of age . 2. Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit. 3. Participants have active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3). 4. Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO. 5. Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit. 6. Participants must have received 1 or more TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with at least one TNFα inhibitor(s) given at an approved dose for ≥3 months or have stopped treatment due to safety/tolerability problems after ≥1 administration of a TNFα inhibitor. Exclusion Criteria: 1. Participants with a known hypersensitivity to sonelokimab or any of its excipients. 2. Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container. 3. Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA. 4. Participants with a diagnosis of inflammatory bowel disease. 5. Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit. 6. Participants who have an established diagnosis of arthritis mutilans. 7. Previous exposure to sonelokimab. 8. Participants who have ever received biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα

Primary outcome measure(s)

  • Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50) — Week 16 compared to placebo
    Proportion of participants achieving ACR50

Trial sites (143)

FacilityCityRegionStatus
Clinical Site Avondale Arizona
Clinical Site Chandler Arizona
Clinical Site Flagstaff Arizona
Clinical Site Mesa Arizona
Clinical Site Phoenix Arizona
Clinical Site Scottsdale Arizona
Clinical Site Tucson Arizona
Clinical Site Jonesboro Arkansas
Clinical Site La Jolla California
Clinical Site Pomona California
Clinical Site San Diego California
Clinical Site Santa Monica California
Clinical Site Thousand Oaks California
Clinical Site Upland California
Clinical Site Avon Park Florida
Clinical Site Clearwater Florida
Clinical Site Hialeah Florida
Clinical Site Miami Gardens Florida
Clinical Site Tampa Florida
Clinical Site Zephyrhills Florida
Clinical Site Gainesville Georgia
Clinical Site Springfield Illinois
Clinical Site Lake Charles Louisiana
Clinical Site Baltimore Maryland
Clinical Site Grand Blanc Michigan
Clinical Site Brooklyn New York
Clinical Site Rochester New York
Clinical Site Charlotte North Carolina
Clinical Site Leland North Carolina
Clinical Site Middleburg Heights Ohio
Clinical Site Portland Oregon
Clinical Site Duncansville Pennsylvania
Clinical Site Jackson Tennessee
Clinical Site Memphis Tennessee
Clinical Site Murfreesboro Tennessee
Clinical Site Allen Texas
Clinical Site Austin Texas
Clinical Site Baytown Texas
Clinical Site Colleyville Texas
Clinical Site Houston Texas

+ 103 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06641089 on ClinicalTrials.gov ↗ ← All trials in the UK