Evaluation of Sonelokimab in Patients with Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug

Phase 3

Recruiting

• Conditions: Arthritis, Psoriatic
• Interventions: Drug: Sonelokimab; Drug: Placebo

• Registration Number: NCT06641076
• Lead Sponsor: MoonLake Immunotherapeutics AG

Brief Summary

This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.

Detailed Description

M1095-PSA-301 is a Phase 3, multicenter, randomized, parallel-group, double-blind, 3-arm, placebo-controlled study to investigate the efficacy and safety of sonelokimab 60 mg every 4 weeks (with and without an induction regimen) versus placebo in adults with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.

Study Timeline

• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-11
• Study Start: 2024-10-15
• Study First Posted: 2024-10-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-03
• Primary Completion: 2027-01-15
• Study Completion: 2027-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 960

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 moderate to severe 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.

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Exclusion Criteria

1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.
2. Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
3. Participants with a diagnosis of inflammatory bowel disease.
4. Participants who have experienced a period of ≥3 weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
5. Participants who have an established diagnosis of arthritis mutilans.
6. Previous exposure to sonelokimab.
7. Participants who have ever received any biologic immunomodulating agents for PsA or PsO, whether investigational or approved.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sonelokimab dose with an induction regimen	Sonelokimab	Subjects randomized to this arm will receive sonelokimab subcutaneously (SC) as an induction regimen of 4 doses, followed by sonelokimab SC every 4 weeks maintenance dosing starting at Week 8.
sonelokimab dose without an induction regimen	Sonelokimab	Subjects randomized to this arm will receive sonelokimab subcutaneously every 4 weeks.
Placebo	Placebo	Subjects randomized to this arm will receive placebo subcutaneously.

Primary Outcome Measures

Name	Time	Method
Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)	Week 16	Proportion of participants achieving ACR50

Secondary Outcome Measures

Name	Time	Method
Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20)	Week 16	Proportion of participants achieving ACR20
Response rate of participants achieving Minimal Disease Activity (MDA)	Week 16	Proportion of participants achieving MDA
Health Assessment Questionnaire- Disability Index (HAQ-DI)	Week 16	Change in HAQ-DI from baseline
Psoriasis Area and Severity Index (PASI90)	Week 16	Proportion of participants achieving a decrease of ≥90% in the PASI90 response at Week 16 in the subgroup of participants with psoriasis (PsO) involving ≥3% body surface area at baseline
Short- form-36 (SF-36) Physical Component Summary (PCS)	Week 16	Change from Baseline in SF-36 PCS at Week 16
van der Heijde modified Total Sharp Score (vdHmTSS)	Week 16	Change from Baseline to Week 16 in joint/bone structural damage (vdHmTSS)

Trial Locations

Locations (1)

Clinical Site; 🇺🇸 Grapevine, Texas, United States