Clinical trial NCT06641076: Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug
Official title: A Phase 3, Parallel-group, Randomized, Double-blind, 3-arm, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis Who Are Naive to Biologic DMARDs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Arthritis, Psoriatic
Lead sponsor: MoonLake Immunotherapeutics AG
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
timeFrame: Week 16
Secondary outcomes:
measure: Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20)
timeFrame: Week 16
measure: Response rate of participants achieving Minimal Disease Activity (MDA)
timeFrame: Week 16
measure: Health Assessment Questionnaire- Disability Index (HAQ-DI)
timeFrame: Week 16
measure: Psoriasis Area and Severity Index (PASI90)
timeFrame: Week 16
measure: Short- form-36 (SF-36) Physical Component Summary (PCS)
timeFrame: Week 16
measure: van der Heijde modified Total Sharp Score (vdHmTSS)
timeFrame: Week 16
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Clinical Site
state: Arizona
city: Flagstaff
country: United States
facility: Clinical Site
state: Arizona
city: Mesa
country: United States
facility: Clinical Site
state: Arizona
city: Phoenix
country: United States
facility: Clinical Site
state: Arizona
city: Phoenix
country: United States
facility: Clinical Site
state: Arizona
city: Scottsdale
country: United States
facility: Clinical Site
state: Arizona
city: Tucson
country: United States
facility: Clinical Site
state: Arizona
city: Upland
country: United States
facility: Clinical Site
state: California
city: Avon Park
country: United States
facility: Clinical Site
state: Florida
city: Clearwater
country: United States
facility: Clinical Site
state: Florida
city: Hialeah
country: United States
facility: Clinical Site
state: Florida
city: Tampa
country: United States
facility: Clinical Site
state: Florida
city: Springfield
country: United States
facility: Clinical Site
state: Illinois
city: Lake Charles
country: United States
facility: Clinical Site
state: Louisiana
city: Grand Blanc
country: United States
facility: Clinical Site
state: Michigan
city: Leland
country: United States
facility: Clinical Site
state: North Carolina
city: Salisbury
country: United States
facility: Clinical Site
state: North Carolina
city: Statesville
country: United States
facility: Clinical Site
state: North Carolina
city: Middleburg Heights
country: United States
facility: Clinical Site
state: Ohio
city: Portland
country: United States
facility: Clinical Site
state: Oregon
city: Memphis
country: United States
facility: Clinical Site
state: Tennessee
city: Allen
country: United States
facility: Clinical Site
state: Texas
city: Colleyville
country: United States
facility: Clinical Site
state: Texas
city: Lubbock
country: United States
facility: Clinical Site
state: Texas
city: Plano
country: United States
facility: Clinical Site
state: Texas
city: Beckley
country: United States
facility: Clinical Site
state: West Virginia
Study officials:
References: