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NCT06641076 | RECRUITING | Arthritis, Psoriatic

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

MoonLake Immunotherapeutics AG

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.

Condition or disease

Arthritis, Psoriatic

Intervention/treatment

Sonelokimab

Placebo

Phase

PHASE3

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 960 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
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
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.
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.
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug

Location Details

NCT06641076

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Clinical Site

Chandler, Arizona, United States, 85225

RECRUITING

United States, Arizona

Clinical Site

Flagstaff, Arizona, United States, 86001

RECRUITING

United States, Arizona

Clinical Site

Mesa, Arizona, United States, 85210

RECRUITING

United States, Arizona

Clinical Site

Phoenix, Arizona, United States, 85032

RECRUITING

United States, Arizona

Clinical Site

Phoenix, Arizona, United States, 85037

RECRUITING

United States, Arizona

Clinical Site

Scottsdale, Arizona, United States, 85260

RECRUITING

United States, Arizona

Clinical Site

Tucson, Arizona, United States, 85748

RECRUITING

United States, California

Clinical Site

Upland, California, United States, 91786

RECRUITING

United States, Florida

Clinical Site

Avon Park, Florida, United States, 33825

RECRUITING

United States, Florida

Clinical Site

Clearwater, Florida, United States, 33765

RECRUITING

United States, Florida

Clinical Site

Hialeah, Florida, United States, 33016

RECRUITING

United States, Florida

Clinical Site

Tampa, Florida, United States, 33607

RECRUITING

United States, Illinois

Clinical Site

Springfield, Illinois, United States, 62702

RECRUITING

United States, Louisiana

Clinical Site

Lake Charles, Louisiana, United States, 70605

RECRUITING

United States, Road cancer

Clinical Site

Tall white, Road cancer, United States, 48439-2451

RECRUITING

United States, North Carolina

Clinical Site

Leland, North Carolina, United States, 28451

RECRUITING

United States, North Carolina

Clinical Site

Salisbury, North Carolina, United States, 28144

RECRUITING

United States, North Carolina

Clinical Site

Statesville, North Carolina, United States, 28625

RECRUITING

United States, Ohio

Clinical Site

Middleburg Heights, Ohio, United States, 44130

RECRUITING

United States, Oregon

Clinical Site

Portland, Oregon, United States, 97239

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

Lubbock, Texas, United States, 79424

RECRUITING

United States, Texas

Clinical Site

Plano, Texas, United States, 75024

RECRUITING

United States, West Virginia

Clinical Site

Beckley, West Virginia, United States, 25801