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

Phase 3

Recruiting

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

• Registration Number: NCT06641089
• Lead Sponsor: MoonLake Immunotherapeutics AG

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 or intolerance to anti-tumor necrosis factor (TNF)α therapy.

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 sonelokimab 60 mg and 120 mg versus placebo in adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α 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: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2027-01-15
• Study Completion: 2027-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.
6. Participants must have received 1 or 2 TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with the 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.

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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.
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 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sonelokimab dose 1 with an induction regimen	Sonelokimab	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.
sonelokimab dose 2 with an induction regimen	Sonelokimab	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.
Placebo	Placebo	Subjects randomized to this arm will receive placebo SC
risankizumab	Risankizumab	Subjects randomized to this arm will receive risankizumab SC

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 compared to placebo	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 compared to placebo	Proportion of participants achieving ACR20
Response rate of participants achieving Minimal Disease Activity (MDA)	Week 16 compared to placebo	Proportion of participants achieving MDA
Health Assessment Questionnaire- Disability Index (HAQ-DI)	Week 16 compared to placebo	Change in HAQ-DI from baseline
Psoriasis Area and Severity Index (PASI90)	Week 16 compared to placebo	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 compared to placebo	Change from Baseline in SF-36 PCS at Week 16
Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)	Week 16 compared to risankzumab	Proportion of participants achieving ACR50

Trial Locations

Locations (1)

Clinical Site; 🇺🇸 Lubbock, Texas, United States