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

Last updated: April 4, 2025
Sponsor: MoonLake Immunotherapeutics AG
Overall Status: Active - Recruiting

Phase

3

Condition

Psoriatic Arthritis

Joint Injuries

Treatment

Sonelokimab

Placebo

Clinical Study ID

NCT06641076
M1095-PSA-301
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants must be ≥18 years of age .

  2. Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 monthsbefore the Screening Visit.

  3. Participants have moderate to severe active disease (defined by a 68 tender jointcount [TJC68] of ≥3 and a 66 swollen joint count [SJC66] of ≥3).

  4. Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmedhistory of plaque PsO.

  5. Participants test negative for both rheumatoid factor and anti-cyclic citrullinatedpeptide at the Screening Visit.

Exclusion

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 PsOor PsA.

  3. Participants with a diagnosis of inflammatory bowel disease.

  4. Participants who have experienced a period of ≥3 weeks of unexplained diarrhea inthe 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 orPsO, whether investigational or approved.

Study Design

Total Participants: 960
Treatment Group(s): 2
Primary Treatment: Sonelokimab
Phase: 3
Study Start date:
October 15, 2024
Estimated Completion Date:
January 15, 2027

Study 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.

Connect with a study center

  • Clinical Site

    Chandler, Arizona 85225
    United States

    Active - Recruiting

  • Clinical Site

    Flagstaff, Arizona 86001
    United States

    Active - Recruiting

  • Clinical Site

    Mesa, Arizona 85210
    United States

    Active - Recruiting

  • Clinical Site

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • Clinical Site

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • Clinical Site

    Tucson, Arizona 85748
    United States

    Active - Recruiting

  • Clinical Site

    Upland, California 91786
    United States

    Active - Recruiting

  • Clinical Site

    Avon Park, Florida 33825
    United States

    Active - Recruiting

  • Clinical Site

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Clinical Site

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • Clinical Site

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Clinical Site

    Springfield, Illinois 62702
    United States

    Active - Recruiting

  • Clinical Site

    Lake Charles, Louisiana 70605
    United States

    Active - Recruiting

  • Clinical Site

    Grand Blanc, Michigan 48439-2451
    United States

    Active - Recruiting

  • Clinical Site

    Leland, North Carolina 28451
    United States

    Active - Recruiting

  • Clinical Site

    Salisbury, North Carolina 28144
    United States

    Active - Recruiting

  • Clinical Site

    Statesville, North Carolina 28625
    United States

    Active - Recruiting

  • Clinical Site

    Middleburg Heights, Ohio 44130
    United States

    Active - Recruiting

  • Clinical Site

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Clinical Site

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

  • Clinical Site

    Allen, Texas 75013
    United States

    Active - Recruiting

  • Clinical Site

    Colleyville, Texas 76034
    United States

    Active - Recruiting

  • Clinical Site

    Grapevine, Texas 76051
    United States

    Site Not Available

  • Clinical Site

    Lubbock, Texas 79424
    United States

    Active - Recruiting

  • Clinical Site

    Plano, Texas 75024
    United States

    Active - Recruiting

  • Clinical Site

    Beckley, West Virginia 25801
    United States

    Active - Recruiting

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