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NCT06641089 | RECRUITING | Arthritis, Psoriatic

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

Condition or disease

Arthritis, Psoriatic

Intervention/treatment

Sonelokimab

Placebo

Risankizumab

Phase

PHASE3

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 Type : INTERVENTIONAL
Estimated Enrollment : 600 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-10-15
Estimated Primary Completion Date : 2027-01-15
Estimated Study Completion Date : 2027-01-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Evaluation of Sonelokimab in Patients with Active Psoriatic Arthritis and Anti-TNFα Inadequate Response

Location Details

NCT06641089

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How to Participate

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Locations

RECRUITING

United States, Arizona

Clinical Site

Scottsdale, Arizona, United States, 85260

RECRUITING

United States, California

Clinical Site

Upland, California, United States, 91786

RECRUITING

United States, Ohio

Clinical Site

Middleburg Heights, Ohio, United States, 44130

RECRUITING

United States, Pennsylvania

Clinical Site

Duncansville, Pennsylvania, United States, 16635

RECRUITING

United States, Tennessee

Clinical Site

Memphis, Tennessee, United States, 38119

RECRUITING

United States, Texas

Clinical Site

Allen, Texas, United States, 75013

RECRUITING

United States, Texas

Clinical Site

Colleyville, Texas, United States, 76034

RECRUITING

United States, Texas

Clinical Site

Grapevine, Texas, United States, 76051

RECRUITING

United States, Texas

Clinical Site

Lubbock, Texas, United States, 79424