Recruiting
Phase 3

Sonelokimab

Sponsor:

MoonLake Immunotherapeutics AG

Code:

NCT06641089

Conditions

Arthritis, Psoriatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sonelokimab

Placebo

Risankizumab

Study Details

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.

Conditions

Arthritis, Psoriatic

Study ID

NCT06641089

Start date

Oct 15, 2024

Status verified date

Aug, 2026

Completion date

Jan 15, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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 more TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with at least one 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 or component of the container.
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 consecutive 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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: sonelokimab dose 1 with an induction regimen

Subjects randomized to this arm will receive sonelokimab dose 1 subcutaneously (SC) as an induction regimen of 4 doses , followed by sonelokimab SC every 4 weeks (Q4W) maintenance dosing starting at Week 8.

experimental: sonelokimab dose 2 with an induction regimen

Subjects randomized to this arm will receive sonelokimab dose 2 SC as an induction regimen of 4 doses, followed by sonelokimab SC Q4W maintenance dosing starting at Week 8.

placebo comparator: Placebo

Subjects randomized to this arm will receive placebo SC

active comparator: risankizumab

Subjects randomized to this arm will receive risankizumab SC

Interventions

Sonelokimab

Sonelokimab

Placebo

Placebo

Risankizumab

Active comparator

Primary outcome measure

  • Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50) [ Time Frame: Week 16 compared to placebo ]

Central Contacts and Locations

Central contacts

Moonlake Clinical Trial Helpdesk

+41 41 510 8022ClinicalTrials@moonlaketx.com

Locations

Clinical Site

Recruiting

Avondale, Arizona, United States, 85392

Clinical Site

Recruiting

Mesa, Arizona, United States, 85210

Clinical Site

Recruiting

Phoenix, Arizona, United States, 85032

Clinical Site

Recruiting

Scottsdale, Arizona, United States, 85260

Clinical Site

Recruiting

Tucson, Arizona, United States, 85748

Clinical Site

Recruiting

Jonesboro, Arkansas, United States, 72401

Clinical Site

Recruiting

La Jolla, California, United States, 92037

Clinical Site

Recruiting

Pomona, California, United States, 91767

Clinical Site

Recruiting

Santa Monica, California, United States, 90404

Clinical Site

Recruiting

Thousand Oaks, California, United States, 91360

Clinical Site

Recruiting

Upland, California, United States, 91786

Clinical Site

Recruiting

Avon Park, Florida, United States, 33825

Clinical Site

Recruiting

Clearwater, Florida, United States, 33765

Clinical Site

Recruiting

Hialeah, Florida, United States, 33016

Clinical Site

Recruiting

Miami Gardens, Florida, United States, 33014

Clinical Site

Recruiting

Tampa, Florida, United States, 33607

Clinical Site

Recruiting

Zephyrhills, Florida, United States, 33542

Clinical Site

Recruiting

Gainesville, Georgia, United States, 30501

Clinical Site

Recruiting

Springfield, Illinois, United States, 62702

Clinical Site

Recruiting

Lake Charles, Louisiana, United States, 70605

Clinical Site

Recruiting

Baltimore, Maryland, United States, 21224-6821

Clinical Site

Recruiting

Brooklyn, New York, United States, 11201

Clinical Site

Recruiting

Rochester, New York, United States, 14642

Clinical Site

Recruiting

Charlotte, North Carolina, United States, 28262

Clinical Site

Recruiting

Leland, North Carolina, United States, 28451

Clinical Site

Recruiting

Middleburg Heights, Ohio, United States, 44130

Clinical Site

Recruiting

Portland, Oregon, United States, 97239

Clinical Site

Recruiting

Duncansville, Pennsylvania, United States, 16635

Clinical Site

Recruiting

Jackson, Tennessee, United States, 38305

Clinical Site

Recruiting

Memphis, Tennessee, United States, 38119

Clinical Site

Recruiting

Austin, Texas, United States, 78745

Clinical Site

Recruiting

Baytown, Texas, United States, 77521

Clinical Site

Recruiting

Colleyville, Texas, United States, 76034

Clinical Site

Recruiting

Lubbock, Texas, United States, 79424

Clinical Site

Recruiting

Seattle, Washington, United States, 98122

Clinical Site

Recruiting

Beckley, West Virginia, United States, 25801

Clinical Site

Recruiting

Toronto, Ontario, Canada, M5S1B2

Clinical Site

Recruiting

Calgary, Canada, T2N 4L7

Clinical Site

Recruiting

Trois-Rivières, Canada, G9A 3X2

Clinical Site

Recruiting

Winnipeg, Canada, R3A IM3

More Information

Sponsor

MoonLake Immunotherapeutics AG

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by MoonLake Immunotherapeutics AG on 2026-08-12.