Status:
RECRUITING
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
Lead Sponsor:
MoonLake Immunotherapeutics AG
Conditions:
Arthritis, Psoriatic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
M1095-PSA-302 is 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 s...
Eligibility Criteria
Inclusion
- Participants must be ≥18 years of age .
- 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.
- Participants have active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3).
- Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
- Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.
- 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
- Participants with a known hypersensitivity to sonelokimab or any of its excipients.
- Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container.
- Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
- Participants with a diagnosis of inflammatory bowel disease.
- Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
- Participants who have an established diagnosis of arthritis mutilans.
- Previous exposure to sonelokimab.
- Participants who have ever received biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2027
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06641089
Start Date
October 15 2024
End Date
January 15 2027
Last Update
March 11 2026
Active Locations (126)
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1
Clinical Site
Avondale, Arizona, United States, 85392
2
Clinical Site
Chandler, Arizona, United States, 85225
3
Clinical Site
Flagstaff, Arizona, United States, 86001
4
Clinical Site
Mesa, Arizona, United States, 85210