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

Last updated: December 12, 2024
Sponsor: MoonLake Immunotherapeutics AG
Overall Status: Active - Recruiting

Phase

3

Condition

Psoriatic Arthritis

Joint Injuries

Treatment

Sonelokimab

Risankizumab

Placebo

Clinical Study ID

NCT06641089
M1095-PSA-302
  • Ages > 18
  • All Genders

Study 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.

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.

  6. Participants must have received 1 or 2 TNFα inhibitors for PsA or PsO and must haveexperienced an inadequate response to treatment with the TNFα inhibitor(s) given atan approved dose for ≥3 months or have stopped treatment due to safety/tolerabilityproblems after ≥1 administration of a TNFα inhibitor.

Exclusion

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 risankizumabor any of its excipients.

  3. Participants who have a diagnosis of chronic inflammatory conditions other than PsOor PsA.

  4. Participants with a diagnosis of inflammatory bowel disease.

  5. Participants who have experienced a period of ≥3 weeks of unexplained diarrhea inthe 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 PsOwhether investigational or approved, except for those targeting TNFα

Study Design

Total Participants: 600
Treatment Group(s): 3
Primary Treatment: Sonelokimab
Phase: 3
Study Start date:
October 15, 2024
Estimated Completion Date:
January 15, 2027

Study 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.

Connect with a study center

  • Clinical Site

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • Clinical Site

    Upland, California 91786
    United States

    Active - Recruiting

  • Clinical Site

    Middleburg Heights, Ohio 44130
    United States

    Active - Recruiting

  • Clinical Site

    Duncansville, Pennsylvania 16635
    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

    Active - Recruiting

  • Clinical Site

    Lubbock, Texas 79424
    United States

    Active - Recruiting

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