Clinical trial NCT06641089: Evaluation of Sonelokimab in Patients with Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
Official title: 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 Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over with Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors
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: 600
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 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.

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.
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.

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

Primary outcomes:
measure: Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
timeFrame: Week 16 compared to placebo
Secondary outcomes:
measure: Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20)
timeFrame: Week 16 compared to placebo
measure: Response rate of participants achieving Minimal Disease Activity (MDA)
timeFrame: Week 16 compared to placebo
measure: Health Assessment Questionnaire- Disability Index (HAQ-DI)
timeFrame: Week 16 compared to placebo
measure: Psoriasis Area and Severity Index (PASI90)
timeFrame: Week 16 compared to placebo
measure: Short- form-36 (SF-36) Physical Component Summary (PCS)
timeFrame: Week 16 compared to placebo
measure: Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
timeFrame: Week 16 compared to risankzumab
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Clinical Site
state: Arizona
city: Upland
country: United States
facility: Clinical Site
state: California
city: Middleburg Heights
country: United States
facility: Clinical Site
state: Ohio
city: Duncansville
country: United States
facility: Clinical Site
state: Pennsylvania
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: Grapevine
country: United States
facility: Clinical Site
state: Texas
city: Lubbock
country: United States
facility: Clinical Site
state: Texas
Study officials:
References: