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

Last updated: June 10, 2026
Sponsor: MoonLake Immunotherapeutics AG
Overall Status: Active - Recruiting

Phase

3

Condition

Psoriatic Arthritis

Joint Injuries

Treatment

Risankizumab

Placebo

Sonelokimab

Clinical Study ID

NCT06641089
M1095-PSA-302
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants must be ≥18 years of age .

  2. Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 monthsbefore the Screening Visit.

  3. Participants have active disease (defined by a 68 tender joint count [TJC68] of ≥3and a 66 swollen joint count [SJC66] of ≥3).

  4. Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmedhistory of plaque PsO.

  5. Participants test negative for both rheumatoid factor and anti-cyclic citrullinatedpeptide at the Screening Visit.

  6. Participants must have received 1 or more TNFα inhibitors for PsA or PsO and musthave experienced an inadequate response to treatment with at least one TNFαinhibitor(s) given at an approved dose for ≥3 months or have stopped treatment dueto safety/tolerability problems after ≥1 administration of a TNFα inhibitor.

Exclusion

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 risankizumabor any of its excipients or component of the container.

  3. Participants who have a diagnosis of chronic inflammatory conditions other than PsOor PsA.

  4. Participants with a diagnosis of inflammatory bowel disease.

  5. Participants who have experienced a period of ≥3 consecutive weeks of unexplaineddiarrhea 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 PsOwhether investigational or approved, except for those targeting TNFα

Study Design

Total Participants: 600
Treatment Group(s): 3
Primary Treatment: Risankizumab
Phase: 3
Study Start date:
October 15, 2024
Estimated Completion Date:
January 15, 2027

Study 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.

Connect with a study center

  • Clinical Site

    Pazardzhik, 4400
    Bulgaria

    Active - Recruiting

  • Clinical Site

    Pleven, 5800
    Bulgaria

    Active - Recruiting

  • Clinical Site

    Plovdiv, 4002
    Bulgaria

    Active - Recruiting

  • Clinical Site

    Plovdiv 728193, 4002
    Bulgaria

    Active - Recruiting

  • Clinical Site

    Rousse, 7000
    Bulgaria

    Active - Recruiting

  • Clinical Site

    Sofia, 1784
    Bulgaria

    Completed

  • Clinical Site

    Sofia 727011, 1606
    Bulgaria

    Active - Recruiting

  • Clinical Site

    Stara Zagora, 6003
    Bulgaria

    Active - Recruiting

  • Clinical Site

    Toronto, Ontario M5S1B2
    Canada

    Active - Recruiting

  • Clinical Site

    Calgary, T2N 4L7
    Canada

    Active - Recruiting

  • Clinical Site

    Trois-Rivières, G9A 3X2
    Canada

    Active - Recruiting

  • Clinical Site

    Waterloo, N2J 1C4
    Canada

    Completed

  • Clinical Site

    Winnipeg, R3A IM3
    Canada

    Active - Recruiting

  • Clinical Site

    Brno, 63800
    Czechia

    Active - Recruiting

  • Clinical Site

    Ostrava, 70200
    Czechia

    Active - Recruiting

  • Clinical Site

    Studénka, 742 13
    Czechia

    Active - Recruiting

  • Clinical Site

    Zlín, 760 01
    Czechia

    Active - Recruiting

  • Clinical Site

    Caluire-et-Cuire, 69300
    France

    Active - Recruiting

  • Clinical Site

    Montpellier, 34295
    France

    Active - Recruiting

  • Clinical Site

    Narbonne, 11100
    France

    Completed

  • Clinical Site

    Nice, 06001
    France

    Active - Recruiting

  • Clinical Site

    Rouen, 76031
    France

    Active - Recruiting

  • Clinical Site

    Tours, 37170
    France

    Active - Recruiting

  • Clinical Site

    Tbilisi, 0141
    Georgia

    Active - Recruiting

  • Clinical Site

    Tbilisi 611717, 0112
    Georgia

    Active - Recruiting

  • Clinical Site

    Berlin, 12161
    Germany

    Active - Recruiting

  • Clinical Site

    Berlin 2950159, 12161
    Germany

    Active - Recruiting

  • Clinical Site

    Dresden, 01067
    Germany

    Active - Recruiting

  • Clinical Site

    Erlangen, 91054
    Germany

    Active - Recruiting

  • Clinical Site

    Hamburg, 20095
    Germany

    Active - Recruiting

  • Clinical Site

    Herne, 44649
    Germany

    Active - Recruiting

  • Clinical Site

    Munich, 80639
    Germany

    Active - Recruiting

  • Clinical Site

    Munich 2867714, 80639
    Germany

    Active - Recruiting

  • Clinical Site

    München, 80336
    Germany

    Active - Recruiting

  • Clinical Site

    Budapest, 1036
    Hungary

    Completed

  • Clinical Site

    Budapest 3054643, 1036
    Hungary

    Active - Recruiting

  • Clinical Site

    Debrecen, H-4032
    Hungary

    Active - Recruiting

  • Clinical SIte

    Gyula, 5700
    Hungary

    Active - Recruiting

  • Clinical Site

    Hódmezővásárhely, 6800
    Hungary

    Active - Recruiting

  • Clinical Site

    Nyíregyháza, 4400
    Hungary

    Active - Recruiting

  • Clinical Site

    Szolnok, 5000
    Hungary

    Active - Recruiting

  • Clinical Site

    Székesfehérvár, 8000
    Hungary

    Active - Recruiting

  • Clinical Site

    Veszprém, 8200
    Hungary

    Active - Recruiting

  • Clinical Site

    Bialystok, 15707
    Poland

    Active - Recruiting

  • Clinical Site

    Bydgoszcz, 85-065
    Poland

    Active - Recruiting

  • Clinical Site

    Częstochowa, 42-202
    Poland

    Completed

  • Clinical Site

    Elblag, 82-300
    Poland

    Active - Recruiting

  • Clinical Site

    Gdynia, 81-384
    Poland

    Active - Recruiting

  • Clinical Site

    Krakow, 31-501
    Poland

    Active - Recruiting

  • Clinical Site

    Krakow 3094802, 30-149
    Poland

    Active - Recruiting

  • Clinical Site

    Kraków, 30-149
    Poland

    Active - Recruiting

  • Clinical Site

    Lodz, 91-363
    Poland

    Active - Recruiting

  • Clinical Site

    Nadarzyn, 05-830
    Poland

    Active - Recruiting

  • Clinical Site

    Poznan, 61-397
    Poland

    Active - Recruiting

  • Clinical Site

    Poznan 3088171, 60-693
    Poland

    Active - Recruiting

  • Clinical Site

    Poznań, 61-397
    Poland

    Active - Recruiting

  • Clinical Site

    Sochaczew, 96-500
    Poland

    Active - Recruiting

  • Clinical Site

    Swidnica, 58100
    Poland

    Active - Recruiting

  • Clinical Site

    Warsaw, 03-291
    Poland

    Active - Recruiting

  • Clinical Site

    Warsaw 756135, 02-118
    Poland

    Active - Recruiting

  • Clinical Site

    Warszawa, 02-118
    Poland

    Active - Recruiting

  • Clinical Site

    Wołomin, 05-200
    Poland

    Active - Recruiting

  • Clinical Site

    Wroclaw, 53-673
    Poland

    Active - Recruiting

  • Clinical Site

    Wroclaw 3081368, 51-685
    Poland

    Active - Recruiting

  • Clinical Site

    Wrocław, 53-673
    Poland

    Active - Recruiting

  • Clinical Site

    A Coruña, 15006
    Spain

    Active - Recruiting

  • Clinical Site

    Alcobendas, 28100
    Spain

    Active - Recruiting

  • Clinical Site

    Bilbao, 48013
    Spain

    Active - Recruiting

  • Clinical Site

    Castellon, 12004
    Spain

    Active - Recruiting

  • Clinical Site

    Madrid, 28003
    Spain

    Active - Recruiting

  • Clinical Site

    Málaga, 29009
    Spain

    Active - Recruiting

  • Clinical SIte

    Sabadell, 08208
    Spain

    Active - Recruiting

  • Clinical Site

    Santiago de Compostela, 15706
    Spain

    Active - Recruiting

  • Clinical Site

    Santiago de Compostela 3109642, 15706
    Spain

    Active - Recruiting

  • Clinical Site

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Clinical Site

    Seville, 41010
    Spain

    Active - Recruiting

  • Clinical Site

    Seville 2510911, 41009
    Spain

    Active - Recruiting

  • Clinical Site

    Valencia, 46010
    Spain

    Active - Recruiting

  • Clinical Site

    Westcliff-on-Sea, Essex SS0
    United Kingdom

    Active - Recruiting

  • Clinical Site

    Barnet, EN5 3DJ
    United Kingdom

    Active - Recruiting

  • Clinical Site

    Leeds, LS7 4SA
    United Kingdom

    Active - Recruiting

  • Clinical Site

    Avondale, Arizona 85392
    United States

    Active - Recruiting

  • Clinical Site

    Chandler, Arizona 85225
    United States

    Completed

  • Clinical Site

    Flagstaff, Arizona 86001
    United States

    Completed

  • Clinical Site

    Mesa, Arizona 85210
    United States

    Active - Recruiting

  • Clinical Site

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • Clinical Site

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • Clinical Site

    Tucson, Arizona 85748
    United States

    Active - Recruiting

  • Clinical Site

    Jonesboro, Arkansas 72401
    United States

    Active - Recruiting

  • Clinical Site

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Clinical Site

    Pomona, California 91767
    United States

    Active - Recruiting

  • Clinical Site

    San Diego, California 92108
    United States

    Active - Recruiting

  • Clinical Site

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Clinical Site

    Thousand Oaks, California 91360
    United States

    Active - Recruiting

  • Clinical Site

    Upland, California 91786
    United States

    Active - Recruiting

  • Clinical Site

    Avon Park, Florida 33825
    United States

    Active - Recruiting

  • Clinical Site

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Clinical Site

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • Clinical Site

    Miami Gardens, Florida 33014
    United States

    Active - Recruiting

  • Clinical Site

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Clinical Site

    Zephyrhills, Florida 33542
    United States

    Active - Recruiting

  • Clinical Site

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • Clinical Site

    Springfield, Illinois 62702
    United States

    Active - Recruiting

  • Clinical Site

    Lake Charles, Louisiana 70605
    United States

    Active - Recruiting

  • Clinical Site

    Baltimore, Maryland 21224-6821
    United States

    Active - Recruiting

  • Clinical Site

    Grand Blanc, Michigan 48439-2451
    United States

    Active - Recruiting

  • Clinical Site

    Brooklyn, New York 11201
    United States

    Active - Recruiting

  • Clinical Site

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Clinical Site

    Charlotte, North Carolina 28262
    United States

    Active - Recruiting

  • Clinical Site

    Leland, North Carolina 28451
    United States

    Active - Recruiting

  • Clinical Site

    Middleburg Heights, Ohio 44130
    United States

    Active - Recruiting

  • Clinical Site

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Clinical Site

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • Clinical Site

    Jackson, Tennessee 38305
    United States

    Active - Recruiting

  • Clinical Site

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

  • Clinical Site

    Murfreesboro, Tennessee 37128
    United States

    Completed

  • Clinical Site

    Allen, Texas 75013
    United States

    Completed

  • Clinical Site

    Austin, Texas 78745
    United States

    Active - Recruiting

  • Clinical Site

    Baytown, Texas 77521
    United States

    Active - Recruiting

  • Clinical Site

    Colleyville, Texas 76034
    United States

    Active - Recruiting

  • Clinical Site

    Houston, Texas 77089
    United States

    Completed

  • Clinical Site

    Lubbock, Texas 79424
    United States

    Active - Recruiting

  • Clinical Site

    Plano, Texas 75024
    United States

    Completed

  • Clinical Site

    Seattle, Washington 98122
    United States

    Active - Recruiting

  • Clinical Site

    Beckley, West Virginia 25801
    United States

    Active - Recruiting

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