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

NCT06641089 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: M1095-PSA-302
• Study Type: interventional
• Target: 600
• Locations: 11 countries
• Sites: 135

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

Outcome Measures

Primary Outcomes (1)

• Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)

  Proportion of participants achieving ACR50

  Week 16 compared to placebo

Secondary Outcomes (6)

• Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20)

  Week 16 compared to placebo

• Response rate of participants achieving Minimal Disease Activity (MDA)

  Week 16 compared to placebo

• Health Assessment Questionnaire- Disability Index (HAQ-DI)

  Week 16 compared to placebo

• Psoriasis Area and Severity Index (PASI90)

  Week 16 compared to placebo

• Short- form-36 (SF-36) Physical Component Summary (PCS)

  Week 16 compared to placebo

Study Arms (4)

sonelokimab dose 1 with an induction regimen

EXPERIMENTAL

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.

Drug: Sonelokimab

sonelokimab dose 2 with an induction regimen

EXPERIMENTAL

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.

Drug: Sonelokimab

Placebo

PLACEBO COMPARATOR

Subjects randomized to this arm will receive placebo SC

Drug: Placebo

risankizumab

ACTIVE COMPARATOR

Subjects randomized to this arm will receive risankizumab SC

Drug: Risankizumab

Interventions

Risankizumab DRUG

Active comparator

risankizumab

Sonelokimab DRUG

Sonelokimab

sonelokimab dose 1 with an induction regimen; sonelokimab dose 2 with an induction regimen

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be ≥18 years of age .
• 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.
• Participants have active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3).
• Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
• Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.
• 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.

You may not qualify if:

• Participants with a known hypersensitivity to sonelokimab or any of its excipients.
• Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container.
• Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
• Participants with a diagnosis of inflammatory bowel disease.
• Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
• Participants who have an established diagnosis of arthritis mutilans.
• Previous exposure to sonelokimab.
• Participants who have ever received biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα

Sponsors & Collaborators

• MoonLake Immunotherapeutics AG: lead

Study Sites (135)

Clinical Site

Avondale, Arizona, 85392, United States

RECRUITING

Clinical Site

Chandler, Arizona, 85225, United States

COMPLETED

Clinical Site

Flagstaff, Arizona, 86001, United States

COMPLETED

Clinical Site

Mesa, Arizona, 85210, United States

RECRUITING

Clinical Site

Phoenix, Arizona, 85032, United States

RECRUITING

Clinical Site

Scottsdale, Arizona, 85260, United States

RECRUITING

Clinical Site

Tucson, Arizona, 85748, United States

RECRUITING

Clinical Site

Jonesboro, Arkansas, 72401, United States

RECRUITING

Clinical Site

La Jolla, California, 92037, United States

RECRUITING

Clinical Site

Pomona, California, 91767, United States

RECRUITING

Clinical Site

San Diego, California, 92108, United States

RECRUITING

Clinical Site

Santa Monica, California, 90404, United States

RECRUITING

Clinical Site

Thousand Oaks, California, 91360, United States

RECRUITING

Clinical Site

Upland, California, 91786, United States

RECRUITING

Clinical Site

Avon Park, Florida, 33825, United States

RECRUITING

Clinical Site

Clearwater, Florida, 33765, United States

RECRUITING

Clinical Site

Hialeah, Florida, 33016, United States

RECRUITING

Clinical Site

Miami Gardens, Florida, 33014, United States

RECRUITING

Clinical Site

Tampa, Florida, 33607, United States

RECRUITING

Clinical Site

Zephyrhills, Florida, 33542, United States

RECRUITING

Clinical Site

Gainesville, Georgia, 30501, United States

RECRUITING

Clinical Site

Springfield, Illinois, 62702, United States

RECRUITING

Clinical Site

Lake Charles, Louisiana, 70605, United States

RECRUITING

Clinical Site

Baltimore, Maryland, 21224-6821, United States

RECRUITING

Clinical Site

Grand Blanc, Michigan, 48439-2451, United States

RECRUITING

Clinical Site

Brooklyn, New York, 11201, United States

RECRUITING

Clinical Site

Rochester, New York, 14642, United States

RECRUITING

Clinical Site

Charlotte, North Carolina, 28262, United States

RECRUITING

Clinical Site

Leland, North Carolina, 28451, United States

RECRUITING

Clinical Site

Middleburg Heights, Ohio, 44130, United States

RECRUITING

Clinical Site

Portland, Oregon, 97239, United States

RECRUITING

Clinical Site

Duncansville, Pennsylvania, 16635, United States

RECRUITING

Clinical Site

Jackson, Tennessee, 38305, United States

RECRUITING

Clinical Site

Memphis, Tennessee, 38119, United States

RECRUITING

Clinical Site

Murfreesboro, Tennessee, 37128, United States

COMPLETED

Clinical Site

Allen, Texas, 75013, United States

RECRUITING

Clinical Site

Austin, Texas, 78745, United States

RECRUITING

Clinical Site

Baytown, Texas, 77521, United States

RECRUITING

Clinical Site

Colleyville, Texas, 76034, United States

RECRUITING

Clinical Site

Houston, Texas, 77089, United States

COMPLETED

Clinical Site

Lubbock, Texas, 79424, United States

RECRUITING

Clinical Site

Plano, Texas, 75024, United States

RECRUITING

Clinical Site

Seattle, Washington, 98122, United States

RECRUITING

Clinical Site

Beckley, West Virginia, 25801, United States

RECRUITING

Clinical Site

Pazardzhik, 4400, Bulgaria

RECRUITING

Clinical Site

Pleven, 5800, Bulgaria

RECRUITING

Clinical Site

Plovdiv, 4000, Bulgaria

RECRUITING

Clinical Site

Plovdiv, 4001, Bulgaria

RECRUITING

Clinical Site

Plovdiv, 4002, Bulgaria

RECRUITING

Clinical Site

Plovdiv, 4004, Bulgaria

RECRUITING

Clinical Site

Rousse, 7000, Bulgaria

RECRUITING

Clinical Site

Sofia, 1606, Bulgaria

RECRUITING

Clinical Site

Sofia, 1784, Bulgaria

RECRUITING

Clinical Site

Stara Zagora, 6003, Bulgaria

RECRUITING

Clinical Site

Toronto, Ontario, M5S1B2, Canada

RECRUITING

Clinical Site

Calgary, T2N 4L7, Canada

RECRUITING

Clinical Site

Trois-Rivières, G9A 3X2, Canada

RECRUITING

Clinical Site

Waterloo, N2J 1C4, Canada

RECRUITING

Clinical Site

Winnipeg, R3A IM3, Canada

RECRUITING

Clinical Site

Brno, 63800, Czechia

RECRUITING

Clinical Site

Ostrava, 70200, Czechia

RECRUITING

Clinical Site

Studénka, 742 13, Czechia

RECRUITING

Clinical Site

Zlín, 760 01, Czechia

RECRUITING

Clinical Site

Caluire-et-Cuire, 69300, France

RECRUITING

Clinical Site

Montpellier, 34295, France

RECRUITING

Clinical Site

Narbonne, 11100, France

COMPLETED

Clinical Site

Nice, 06001, France

RECRUITING

Clinical Site

Rouen, 76031, France

RECRUITING

Clinical Site

Tours, 37170, France

RECRUITING

Clinical Site

Tbilisi, 0102, Georgia

RECRUITING

Clinical Site

Tbilisi, 0112, Georgia

RECRUITING

Clinical Site

Tbilisi, 0141, Georgia

RECRUITING

Clinical Site

Tbilisi, 0159, Georgia

RECRUITING

Clinical Site

Tbilisi, 0179, Georgia

RECRUITING

Clinical Site

Tbilisi, 0180, Georgia

RECRUITING

Clinical Site

Berlin, 12161, Germany

RECRUITING

Clinical Site

Berlin, 12203, Germany

RECRUITING

Clinical Site

Berlin, 13125, Germany

RECRUITING

Clinical Site

Dresden, 01067, Germany

RECRUITING

Clinical Site

Erlangen, 91054, Germany

RECRUITING

Clinical Site

Hamburg, 20095, Germany

RECRUITING

Clinical Site

Herne, 44649, Germany

RECRUITING

Clinical Site

Munich, 80639, Germany

RECRUITING

Clinical Site

Munich, 81667, Germany

RECRUITING

Clinical Site

München, 80336, Germany

RECRUITING

Clinical Site

Budapest, 1027, Hungary

RECRUITING

Clinical Site

Budapest, 1036, Hungary

RECRUITING

Clinical Site

Budapest, 1036, Hungary

COMPLETED

Clinical Site

Debrecen, H-4032, Hungary

RECRUITING

Clinical SIte

Gyula, 5700, Hungary

RECRUITING

Clinical Site

Hódmezővásárhely, 6800, Hungary

RECRUITING

Clinical Site

Nyíregyháza, 4400, Hungary

RECRUITING

Clinical Site

Székesfehérvár, 8000, Hungary

RECRUITING

Clinical Site

Szolnok, 5000, Hungary

RECRUITING

Clinical Site

Veszprém, 8200, Hungary

RECRUITING

Clinical Site

Bialystok, 15707, Poland

RECRUITING

Clinical Site

Bydgoszcz, 85-065, Poland

RECRUITING

Clinical Site

Częstochowa, 42-202, Poland

RECRUITING

Clinical Site

Elblag, 82-300, Poland

RECRUITING

Clinical Site

Gdynia, 81-384, Poland

RECRUITING

Clinical Site

Krakow, 30-002, Poland

RECRUITING

Clinical Site

Krakow, 30-149, Poland

RECRUITING

Clinical Site

Krakow, 31-501, Poland

RECRUITING

Clinical Site

Lodz, 91-363, Poland

RECRUITING

Clinical Site

Nadarzyn, 05-830, Poland

RECRUITING

Clinical Site

Poznan, 60-324, Poland

RECRUITING

Clinical Site

Poznan, 60-446, Poland

RECRUITING

Clinical Site

Poznan, 60-693, Poland

RECRUITING

Clinical Site

Poznan, 61-397, Poland

RECRUITING

Clinical Site

Sochaczew, 96-500, Poland

RECRUITING

Clinical Site

Swidnica, 58100, Poland

RECRUITING

Clinical Site

Warsaw, 00-874, Poland

RECRUITING

Clinical Site

Warsaw, 02-118, Poland

RECRUITING

Clinical Site

Warsaw, 02-665, Poland

RECRUITING

Clinical Site

Warsaw, 02-677, Poland

RECRUITING

Clinical Site

Warsaw, 03-291, Poland

RECRUITING

Clinical Site

Warsaw, 04-305, Poland

RECRUITING

Clinical Site

Wołomin, 05-200, Poland

RECRUITING

Clinical Site

Wroclaw, 51-685, Poland

RECRUITING

Clinical Site

Wroclaw, 53-673, Poland

RECRUITING

Clinical Site

A Coruña, 15006, Spain

RECRUITING

Clinical Site

Bilbao, 48013, Spain

RECRUITING

Clinical Site

Castellon, 12004, Spain

RECRUITING

Clinical Site

Madrid, 28003, Spain

RECRUITING

Clinical Site

Málaga, 29009, Spain

RECRUITING

Clinical SIte

Sabadell, 08208, Spain

RECRUITING

Clinical Site

Santiago de Compostela, 15702, Spain

RECRUITING

Clinical Site

Santiago de Compostela, 15706, Spain

RECRUITING

Clinical Site

Seville, 41009, Spain

RECRUITING

Clinical Site

Seville, 41010, Spain

RECRUITING

Clinical Site

Seville, 41013, Spain

RECRUITING

Clinical Site

Valencia, 46010, Spain

RECRUITING

Clinical Site

Westcliff-on-Sea, Essex, SS0, United Kingdom

RECRUITING

Clinical Site

Barnet, EN5 3DJ, United Kingdom

RECRUITING

Clinical Site

Leeds, LS7 4SA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

sonelokimab; risankizumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Moonlake Clinical Trial Helpdesk

CONTACT

+41 41 510 8022; ClinicalTrials@moonlaketx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

GB (3); GE (6); DE (10); BU (10); PL (25); US (44); CA (5); CZ (4); FR (6); HU (10); ES (12)