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NCT06641089PHASE3Recruiting

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

MoonLake Immunotherapeutics AG

Start Date

10/15/2024

Completion Date

1/15/2027

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Sonelokimab

DRUG

Placebo

DRUG

Risankizumab

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Conditions

Arthritis, Psoriatic

Locations

Clinical Site

Avondale, Arizona 85392

United States

Clinical Site

Chandler, Arizona 85225

United States

Clinical Site

Flagstaff, Arizona 86001

United States

Clinical Site

Mesa, Arizona 85210

United States

Clinical Site

Phoenix, Arizona 85032

United States

Clinical Site

Scottsdale, Arizona 85260

United States

Clinical Site

Tucson, Arizona 85748

United States

Clinical Site

Jonesboro, Arkansas 72401

United States

Clinical Site

La Jolla, California 92037

United States

Clinical Site

Pomona, California 91767

United States

Clinical Site

San Diego, California 92108

United States

Clinical Site

Santa Monica, California 90404

United States

Clinical Site

Thousand Oaks, California 91360

United States

Clinical Site

Upland, California 91786

United States

Clinical Site

Avon Park, Florida 33825

United States

Clinical Site

Clearwater, Florida 33765

United States

Clinical Site

Hialeah, Florida 33016

United States

Clinical Site

Miami Gardens, Florida 33014

United States

Clinical Site

Tampa, Florida 33607

United States

Clinical Site

Zephyrhills, Florida 33542

United States

Clinical Site

Gainesville, Georgia 30501

United States

Clinical Site

Springfield, Illinois 62702

United States

Clinical Site

Lake Charles, Louisiana 70605

United States

Clinical Site

Baltimore, Maryland 21224-6821

United States

Clinical Site

Grand Blanc, Michigan 48439-2451

United States

Clinical Site

Brooklyn, New York 11201

United States

Clinical Site

Rochester, New York 14642

United States

Clinical Site

Charlotte, North Carolina 28262

United States

Clinical Site

Leland, North Carolina 28451

United States

Clinical Site

Middleburg Heights, Ohio 44130

United States

Clinical Site

Portland, Oregon 97239

United States

Clinical Site

Duncansville, Pennsylvania 16635

United States

Clinical Site

Jackson, Tennessee 38305

United States

Clinical Site

Memphis, Tennessee 38119

United States

Clinical Site

Murfreesboro, Tennessee 37128

United States

Clinical Site

Allen, Texas 75013

United States

Clinical Site

Austin, Texas 78745

United States

Clinical Site

Baytown, Texas 77521

United States

Clinical Site

Colleyville, Texas 76034

United States

Clinical Site

Houston, Texas 77089

United States

Clinical Site

Lubbock, Texas 79424

United States

Clinical Site

Plano, Texas 75024

United States

Clinical Site

Seattle, Washington 98122

United States

Clinical Site

Beckley, West Virginia 25801

United States

Clinical Site

Pazardzhik, 4400

Bulgaria

Clinical Site

Pleven, 5800

Bulgaria

Clinical Site

Plovdiv, 4000

Bulgaria

Clinical Site

Plovdiv, 4001

Bulgaria

Clinical Site

Plovdiv, 4002

Bulgaria

Clinical Site

Plovdiv, 4003

Bulgaria

Clinical Site

Plovdiv, 4004

Bulgaria

Clinical Site

Rousse, 7000

Bulgaria

Clinical Site

Sofia, 1606

Bulgaria

Clinical Site

Sofia, 1784

Bulgaria

Clinical Site

Stara Zagora, 6003

Bulgaria

Clinical Site

Toronto, Ontario M5S1B2

Canada

Clinical Site

Calgary, T2N 4L7

Canada

Clinical Site

Trois-Rivières, G9A 3X2

Canada

Clinical Site

Waterloo, N2J 1C4

Canada

Clinical Site

Winnipeg, R3A IM3

Canada

Clinical Site

Brno, 63800

Czechia

Clinical Site

Ostrava, 70200

Czechia

Clinical Site

Studénka, 742 13

Czechia

Clinical Site

Zlín, 760 01

Czechia

Clinical Site

Caluire-et-Cuire, 69300

France

Clinical Site

Montpellier, 34295

France

Clinical Site

Narbonne, 11100

France

Clinical Site

Nice, 06001

France

Clinical Site

Rouen, 76031

France

Clinical Site

Tours, 37170

France

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Tbilisi, 0102

Georgia

Clinical Site

Tbilisi, 0112

Georgia

Clinical Site

Tbilisi, 0141

Georgia

Clinical Site

Tbilisi, 0159

Georgia

Clinical Site

Tbilisi, 0179

Georgia

Clinical Site

Tbilisi, 0180

Georgia

Clinical Site

Tbilisi, 0186

Georgia

Clinical Site

Tbilisi,

Georgia

Clinical Site

Berlin, 12161

Germany

Clinical Site

Berlin, 12203

Germany

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Berlin, 13125

Germany

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Dresden, 01067

Germany

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Erlangen, 91054

Germany

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Hamburg, 20095

Germany

Clinical Site

Herne, 44649

Germany

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Munich, 80639

Germany

Clinical Site

Munich, 81667

Germany

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München, 80336

Germany

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Budapest, 1027

Hungary

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Budapest, 1036

Hungary

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Debrecen, H-4032

Hungary

Clinical SIte

Gyula, 5700

Hungary

Clinical Site

Hódmezővásárhely, 6800

Hungary

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Nyíregyháza, 4400

Hungary

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Székesfehérvár, 8000

Hungary

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Szolnok, 5000

Hungary

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Veszprém, 8200

Hungary

Clinical Site

Bialystok, 15707

Poland

Clinical Site

Bydgoszcz, 85-065

Poland

Clinical Site

Częstochowa, 42-202

Poland

Clinical Site

Elblag, 82-300

Poland

Clinical Site

Gdynia, 81-384

Poland

Clinical Site

Krakow, 30-002

Poland

Clinical Site

Krakow, 30-149

Poland

Clinical Site

Krakow, 31-501

Poland

Clinical Site

Lodz, 91-363

Poland

Clinical Site

Nadarzyn, 05-830

Poland

Clinical Site

Poznan, 60-324

Poland

Clinical Site

Poznan, 60-446

Poland

Clinical Site

Poznan, 60-693

Poland

Clinical Site

Poznan, 61-397

Poland

Clinical Site

Sochaczew, 96-500

Poland

Clinical Site

Swidnica, 58100

Poland

Clinical Site

Warsaw, 00-874

Poland

Clinical Site

Warsaw, 02-118

Poland

Clinical Site

Warsaw, 02-665

Poland

Clinical Site

Warsaw, 02-677

Poland

Clinical Site

Warsaw, 02-786

Poland

Clinical Site

Warsaw, 03-291

Poland

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Warsaw, 04-305

Poland

Clinical Site

Wołomin, 05-200

Poland

Clinical Site

Wroclaw, 51-685

Poland

Clinical Site

Wroclaw, 53-673

Poland

Clinical Site

A Coruña, 15006

Spain

Clinical Site

Alcobendas, 28100

Spain

Clinical Site

Bilbao, 48013

Spain

Clinical Site

Castellon, 12004

Spain

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Madrid, 28003

Spain

Clinical Site

Málaga, 29009

Spain

Clinical SIte

Sabadell, 08208

Spain

Clinical Site

Santiago de Compostela, 15702

Spain

Clinical Site

Santiago de Compostela, 15706

Spain

Clinical Site

Seville, 41009

Spain

Clinical Site

Seville, 41010

Spain

Clinical Site

Seville, 41013

Spain

Clinical Site

Valencia, 46010

Spain

Clinical Site

Westcliff-on-Sea, Essex SS0

United Kingdom

Clinical Site

Barnet, EN5 3DJ

United Kingdom

Clinical Site

Leeds, LS7 4SA

United Kingdom