Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug (IZAR-1)

May 14, 2026 updated by: MoonLake Immunotherapeutics AG

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

960

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Clinical Site
      • Plovdiv, Bulgaria, 4004
        • Clinical Site
      • Plovdiv, Bulgaria, 4002
        • Clinical Site
      • Plovdiv, Bulgaria, 4000
        • Clinical Site
      • Plovdiv, Bulgaria, 4001
        • Clinical Site
      • Rousse, Bulgaria, 7000
        • Clinical Site
      • Sofia, Bulgaria, 1463
        • Clinical Site
      • Sofia, Bulgaria, 1606
        • Clinical Site
      • Sofia, Bulgaria, 1784
        • Clinical Site
      • Stara Zagora, Bulgaria, 6003
        • Clinical Site
  • Canada
      • Calgary, Canada, T2N 4L7
        • Clinical Site
      • Trois-Rivières, Canada, G9A 3X2
        • Clinical Site
      • Waterloo, Canada, N2J 1C4
        • Clinical Site
      • Winnipeg, Canada, R3A IM3
        • Clinical Site
  • Croatia
      • Rijeka, Croatia, 51 000
        • Clinical Site
      • Zagreb, Croatia, 10000
        • Clinical Site
  • Czechia
      • Brno, Czechia, 63800
        • Clinical Site
      • Břeclav, Czechia, 690 02
        • Clinical Site
      • Ostrava, Czechia, 70200
        • Clinical Site
      • Prague, Czechia, 12850
        • Clinical Site
      • Prague, Czechia, 140 00
        • Clinical Site
      • Prague, Czechia, 14800
        • Clinical Site
      • Prague, Czechia, 150 00
        • Clinical Site
      • Studénka, Czechia, 742 13
        • Clinical Site
      • Zlín, Czechia, 760 01
        • Clinical Site
  • Estonia
      • Tallinn, Estonia, 10117
        • Clinical Site
      • Tallinn, Estonia, 13419
        • Clinical Site
      • Tartu, Estonia, 50708
        • Clinical Site
  • Finland
      • Kuopio, Finland, 70100
        • Clinical Site
  • France
      • Cahors, France, 46000
        • Clinical Site
      • Caluire-et-Cuire, France, 69300
        • Clinical Site
      • Montpellier, France, 34295
        • Clinical Site
      • Narbonne, France, 11100
        • Clinical Site
      • Nice, France, 06001
        • Clinical Site
      • Rouen, France, 76031
        • Clinical Site
      • Tours, France, 37170
        • Clinical Site
      • Échirolles, France, 38700
        • Clinical Site
  • Georgia
      • Kutaisi, Georgia, 4600
        • Clinical Site
      • Tbilisi, Georgia
        • Clinical Site
      • Tbilisi, Georgia, 0102
        • Clinical Site
      • Tbilisi, Georgia, 0112
        • Clinical Site
      • Tbilisi, Georgia, 0141
        • Clinical Site
      • Tbilisi, Georgia, 0159
        • Clinical Site
      • Tbilisi, Georgia, 0160
        • Clinical Site
      • Tbilisi, Georgia, 0179
        • Clinical Site
      • Tbilisi, Georgia, 0180
        • Clinical Site
  • Germany
      • Bad Bentheim, Germany, 48455
        • Clinical Site
      • Berlin, Germany, 12161
        • Clinical Site
      • Berlin, Germany, 12203
        • Clinical Site
      • Berlin, Germany, 13125
        • Clinical Site
      • Erlangen, Germany, 91054
        • Clinical Site
      • Hamburg, Germany, 20095
        • Clinical Site
      • Herne, Germany, 44649
        • Clinical Site
      • Munich, Germany, 80639
        • Clinical Site
      • Munich, Germany, 81667
        • Clinical Site
      • München, Germany, 80336
        • Clinical Site
  • Greece
      • Heraklion, Greece, 71110
        • Clinical Site
    • Attica
      • Athens, Attica, Greece
        • Clinical Site
  • Hungary
      • Budapest, Hungary, 1023
        • Clinical Site
      • Budapest, Hungary, 1027
        • Clinical Site
      • Budapest, Hungary, 1036
        • Clinical Site
      • Debrecen, Hungary, H-4032
        • Clinical Site
      • Gyula, Hungary, 5700
        • Clinical Site
      • Hódmezővásárhely, Hungary, 6800
        • Clinical Site
      • Kalocsa, Hungary, 6300
        • Clinical Site
      • Kistarcsa, Hungary, 2143
        • Clinical Site
      • Nyíregyháza, Hungary, 4400
        • Clinical Site
      • Székesfehérvár, Hungary, 8000
        • Clinical Site
      • Veszprém, Hungary, 8200
        • Clinical Site
  • Latvia
      • Adazi, Latvia, LV2164
        • Clinical Site
      • Riga, Latvia, LV-1001
        • Clinical Site
  • Lithuania
      • Kaunas, Lithuania, 51270
        • Clinical Site
      • Šiauliai, Lithuania, 76231
        • Clinical Site
  • Poland
      • Bialystok, Poland, 15-879
        • Clinical Site
      • Bialystok, Poland, 15707
        • Clinical Site
      • Bydgoszcz, Poland, 85-065
        • Clinical Site
      • Bydgoszcz, Poland, 85-168
        • Clinical Site
      • Bytom, Poland, 41-902
        • Clinical Site
      • Częstochowa, Poland, 42-202
        • Clinical Site
      • Dąbrówka, Poland, 62-069
        • Clinical Site
      • Elblag, Poland, 82-300
        • Clinical Site
      • Gdynia, Poland, 81-384
        • Clinical Site
      • Krakow, Poland, 30-002
        • Clinical Site
      • Krakow, Poland, 30-149
        • Clinical Site
      • Krakow, Poland, 31-501
        • Clinical Site
      • Lodz, Poland, 91-363
        • Clinical Site
      • Lublin, Poland, 20-412
        • Clinical Site
      • Lublin, Poland, 20-607
        • Clinical Site
      • Nadarzyn, Poland, 05-830
        • Clinical Site
      • Nowa Sól, Poland, 67-100
        • Clinical Site
      • Olsztyn, Poland, 10-117
        • Clinical Site
      • Poznan, Poland, 61-113
        • Clinical Site
      • Poznan, Poland, 60-218
        • Clinical Site
      • Poznan, Poland, 60-324
        • Clinical Site
      • Poznan, Poland, 60-446
        • Clinical Site
      • Poznan, Poland, 60-693
        • Clinical Site
      • Poznan, Poland, 61-397
        • Clinical Site
      • Siedlce, Poland, 08-110
        • Clinical Site
      • Sochaczew, Poland, 96-500
        • Clinical Site
      • Swidnica, Poland, 58100
        • Clinical Site
      • Torun, Poland, 87-100
        • Clinical Site
      • Warsaw, Poland, 02-665
        • Clinical Site
      • Warsaw, Poland, 00-874
        • Clinical Site
      • Warsaw, Poland, 01-691
        • Clinical Site
      • Warsaw, Poland, 02-118
        • Clinical Site
      • Warsaw, Poland, 02-677
        • Clinical Site
      • Warsaw, Poland, 03-291
        • Clinical Site
      • Warsaw, Poland, 04-305
        • Clinical Site
      • Wołomin, Poland, 05-200
        • Clinical Site
      • Wroclaw, Poland, 51-685
        • Clinical Site
      • Wroclaw, Poland, 52-416
        • Clinical Site
      • Wroclaw, Poland, 53-673
        • Clinical Site
  • Portugal
      • Braga, Portugal, 4700-000
        • Clinical Site
      • Braga, Portugal, 4710-243
        • Clinical Site
      • Lisbon, Portugal, 1649-035
        • Clinical Site
      • Lisbon, Portugal, 1500-458
        • Clinical Site
  • Romania
      • Bucharest, Romania, 011172
        • Clinical Site
      • Bucharest, Romania, 012071
        • Clinical Site
      • Bucharest, Romania, 020475
        • Clinical Site
      • Bucharest, Romania, 030463
        • Clinical Site
      • Bucharest, Romania, 041303
        • Clinical Site
      • Timișoara, Romania, 300650
        • Clinical Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Site
      • Novi Sad, Serbia, 21000
        • Clinical Site
  • Slovakia
      • Košice, Slovakia, 04011
        • Clinical Site
      • Martin, Slovakia, 036 01
        • Clinical Site
      • Poprad, Slovakia, 058 01
        • Clinical Site
      • Rimavská Sobota, Slovakia, 979 01
        • Clinical Site
  • Spain
      • A Coruña, Spain, 15006
        • Clinical Site
      • Bilbao, Spain, 48013
        • Clinical Site
      • Castelló, Spain, 12004
        • Clinical Site
      • Madrid, Spain, 28046
        • Clinical Site
      • Madrid, Spain, 28003
        • Clinical Site
      • Málaga, Spain, 29009
        • Clinical Site
      • Sabadell, Spain, 08208
        • Clinical Site
      • Santiago de Compostela, Spain, 15702
        • Clinical Site
      • Santiago de Compostela, Spain, 15706
        • Clinical Site
      • Seville, Spain, 41009
        • Clinical Site
      • Seville, Spain, 41010
        • Clinical Site
      • Seville, Spain, 41013
        • Clinical Site
      • Valencia, Spain, 46007
        • Clinical Site
  • United States
    • Arizona
      • Avondale, Arizona, United States, 85392
        • Clinical Site
      • Chandler, Arizona, United States, 85225
        • Clinical Site
      • Flagstaff, Arizona, United States, 86001
        • Clinical Site
      • Mesa, Arizona, United States, 85210
        • Clinical Site
      • Phoenix, Arizona, United States, 85032
        • Clinical Site
      • Scottsdale, Arizona, United States, 85260
        • Clinical Site
      • Tucson, Arizona, United States, 85748
        • Clinical Site
    • California
      • San Diego, California, United States, 92108
        • Clinical Site
      • Upland, California, United States, 91786
        • Clinical Site
    • Florida
      • Avon Park, Florida, United States, 33825
        • Clinical Site
      • Clearwater, Florida, United States, 33765
        • Clinical Site
      • Hialeah, Florida, United States, 33016
        • Clinical Site
      • Tampa, Florida, United States, 33607
        • Clinical Site
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Clinical Site
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Clinical Site
    • Maryland
      • Baltimore, Maryland, United States, 21224-6821
        • Clinical Site
    • Michigan
      • Grand Blanc, Michigan, United States, 48439-2451
        • Clinical Site
    • North Carolina
      • Leland, North Carolina, United States, 28451
        • Clinical Site
      • Salisbury, North Carolina, United States, 28144
        • Clinical Site
      • Statesville, North Carolina, United States, 28625
        • Clinical Site
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Clinical Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Clinical Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Site
    • Texas
      • Allen, Texas, United States, 75013
        • Clinical Site
      • Colleyville, Texas, United States, 76034
        • Clinical Site
      • Lubbock, Texas, United States, 79424
        • Clinical Site
      • Plano, Texas, United States, 75024
        • Clinical Site
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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 consecutive 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sonelokimab dose with an induction regimen
Subjects randomized to this arm will receive sonelokimab subcutaneously (SC) as an induction regimen of 4 doses, followed by sonelokimab SC every 4 weeks maintenance dosing starting at Week 8.
Drug: Sonelokimab
Randomized treatment, parallel-group
Experimental: sonelokimab dose without an induction regimen
Subjects randomized to this arm will receive sonelokimab subcutaneously every 4 weeks.
Drug: Sonelokimab
Randomized treatment, parallel-group
Placebo Comparator: Placebo
Subjects randomized to this arm will receive placebo subcutaneously.
Drug: Placebo
Randomized treatment, parallel-group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
Time Frame: Week 16
Proportion of participants achieving ACR50
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20)
Time Frame: Week 16
Proportion of participants achieving ACR20
Week 16
Response rate of participants achieving Minimal Disease Activity (MDA)
Time Frame: Week 16
Proportion of participants achieving MDA
Week 16
Health Assessment Questionnaire- Disability Index (HAQ-DI)
Time Frame: Week 16
Change in HAQ-DI from baseline
Week 16
Psoriasis Area and Severity Index (PASI90)
Time Frame: Week 16
Proportion of participants achieving a decrease of ≥90% in the PASI90 response at Week 16 in the subgroup of participants with psoriasis (PsO) involving ≥3% body surface area at baseline
Week 16
Short- form-36 (SF-36) Physical Component Summary (PCS)
Time Frame: Week 16
Change from Baseline in SF-36 PCS at Week 16
Week 16
van der Heijde modified Total Sharp Score (vdHmTSS)
Time Frame: Week 16
Change from Baseline to Week 16 in joint/bone structural damage (vdHmTSS)
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MoonLake Immunotherapeutics AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Estimated)

February 4, 2027

Study Completion (Estimated)

February 4, 2027

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M1095-PSA-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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