Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response (IZAR-2)

May 14, 2026 updated by: MoonLake Immunotherapeutics AG

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 Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors

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.

Study Overview

Status

Recruiting

Conditions

Arthritis, Psoriatic

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

600

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 Contact

Name: Moonlake Clinical Trial Helpdesk
Phone Number: +41 41 510 8022
Email: ClinicalTrials@moonlaketx.com

Study Locations

Bulgaria
- - Pazardzhik, Bulgaria, 4400
    - Recruiting
    - Clinical Site
  - Pleven, Bulgaria, 5800
    - Recruiting
    - Clinical Site
  - Plovdiv, Bulgaria, 4004
    - Recruiting
    - Clinical Site
  - Plovdiv, Bulgaria, 4002
    - Recruiting
    - Clinical Site
  - Plovdiv, Bulgaria, 4003
    - Recruiting
    - Clinical Site
  - Plovdiv, Bulgaria, 4000
    - Recruiting
    - Clinical Site
  - Plovdiv, Bulgaria, 4001
    - Recruiting
    - Clinical Site
  - Rousse, Bulgaria, 7000
    - Recruiting
    - Clinical Site
  - Sofia, Bulgaria, 1606
    - Recruiting
    - Clinical Site
  - Sofia, Bulgaria, 1784
    - Completed
    - Clinical Site
  - Stara Zagora, Bulgaria, 6003
    - Recruiting
    - Clinical Site
Canada
- - Calgary, Canada, T2N 4L7
    - Recruiting
    - Clinical Site
  - Trois-Rivières, Canada, G9A 3X2
    - Recruiting
    - Clinical Site
  - Waterloo, Canada, N2J 1C4
    - Recruiting
    - Clinical Site
  - Winnipeg, Canada, R3A IM3
    - Recruiting
    - Clinical Site
- Ontario
  - Toronto, Ontario, Canada, M5S1B2
    - Recruiting
    - Clinical Site
Czechia
- - Brno, Czechia, 63800
    - Recruiting
    - Clinical Site
  - Ostrava, Czechia, 70200
    - Recruiting
    - Clinical Site
  - Studénka, Czechia, 742 13
    - Recruiting
    - Clinical Site
  - Zlín, Czechia, 760 01
    - Recruiting
    - Clinical Site
France
- - Caluire-et-Cuire, France, 69300
    - Recruiting
    - Clinical Site
  - Montpellier, France, 34295
    - Recruiting
    - Clinical Site
  - Narbonne, France, 11100
    - Completed
    - Clinical Site
  - Nice, France, 06001
    - Recruiting
    - Clinical Site
  - Rouen, France, 76031
    - Recruiting
    - Clinical Site
  - Tours, France, 37170
    - Recruiting
    - Clinical Site
Georgia
- - Tbilisi, Georgia, 0102
    - Recruiting
    - Clinical Site
  - Tbilisi, Georgia, 0112
    - Recruiting
    - Clinical Site
  - Tbilisi, Georgia, 0141
    - Recruiting
    - Clinical Site
  - Tbilisi, Georgia, 0159
    - Recruiting
    - Clinical Site
  - Tbilisi, Georgia, 0179
    - Recruiting
    - Clinical Site
  - Tbilisi, Georgia, 0180
    - Recruiting
    - Clinical Site
Germany
- - Berlin, Germany, 12161
    - Recruiting
    - Clinical Site
  - Berlin, Germany, 12203
    - Recruiting
    - Clinical Site
  - Berlin, Germany, 13125
    - Recruiting
    - Clinical Site
  - Dresden, Germany, 01067
    - Recruiting
    - Clinical Site
  - Erlangen, Germany, 91054
    - Recruiting
    - Clinical Site
  - Hamburg, Germany, 20095
    - Recruiting
    - Clinical Site
  - Herne, Germany, 44649
    - Recruiting
    - Clinical Site
  - Munich, Germany, 80639
    - Recruiting
    - Clinical Site
  - Munich, Germany, 81667
    - Recruiting
    - Clinical Site
  - München, Germany, 80336
    - Recruiting
    - Clinical Site
Hungary
- - Budapest, Hungary, 1027
    - Recruiting
    - Clinical Site
  - Budapest, Hungary, 1036
    - Recruiting
    - Clinical Site
  - Budapest, Hungary, 1036
    - Completed
    - Clinical Site
  - Debrecen, Hungary, H-4032
    - Recruiting
    - Clinical Site
  - Gyula, Hungary, 5700
    - Recruiting
    - Clinical Site
  - Hódmezővásárhely, Hungary, 6800
    - Recruiting
    - Clinical Site
  - Nyíregyháza, Hungary, 4400
    - Recruiting
    - Clinical Site
  - Szolnok, Hungary, 5000
    - Recruiting
    - Clinical Site
  - Székesfehérvár, Hungary, 8000
    - Recruiting
    - Clinical Site
  - Veszprém, Hungary, 8200
    - Recruiting
    - Clinical Site
Poland
- - Bialystok, Poland, 15707
    - Recruiting
    - Clinical Site
  - Bydgoszcz, Poland, 85-065
    - Recruiting
    - Clinical Site
  - Częstochowa, Poland, 42-202
    - Completed
    - Clinical Site
  - Elblag, Poland, 82-300
    - Recruiting
    - Clinical Site
  - Gdynia, Poland, 81-384
    - Recruiting
    - Clinical Site
  - Krakow, Poland, 30-002
    - Recruiting
    - Clinical Site
  - Krakow, Poland, 30-149
    - Recruiting
    - Clinical Site
  - Krakow, Poland, 31-501
    - Recruiting
    - Clinical Site
  - Lodz, Poland, 91-363
    - Recruiting
    - Clinical Site
  - Nadarzyn, Poland, 05-830
    - Recruiting
    - Clinical Site
  - Poznan, Poland, 60-324
    - Recruiting
    - Clinical Site
  - Poznan, Poland, 60-446
    - Recruiting
    - Clinical Site
  - Poznan, Poland, 60-693
    - Recruiting
    - Clinical Site
  - Poznan, Poland, 61-397
    - Recruiting
    - Clinical Site
  - Sochaczew, Poland, 96-500
    - Recruiting
    - Clinical Site
  - Swidnica, Poland, 58100
    - Recruiting
    - Clinical Site
  - Warsaw, Poland, 02-665
    - Recruiting
    - Clinical Site
  - Warsaw, Poland, 03-291
    - Recruiting
    - Clinical Site
  - Warsaw, Poland, 00-874
    - Recruiting
    - Clinical Site
  - Warsaw, Poland, 02-118
    - Recruiting
    - Clinical Site
  - Warsaw, Poland, 02-677
    - Recruiting
    - Clinical Site
  - Warsaw, Poland, 04-305
    - Recruiting
    - Clinical Site
  - Wołomin, Poland, 05-200
    - Recruiting
    - Clinical Site
  - Wroclaw, Poland, 51-685
    - Recruiting
    - Clinical Site
  - Wroclaw, Poland, 53-673
    - Recruiting
    - Clinical Site
Spain
- - A Coruña, Spain, 15006
    - Recruiting
    - Clinical Site
  - Bilbao, Spain, 48013
    - Recruiting
    - Clinical Site
  - Castellon, Spain, 12004
    - Recruiting
    - Clinical Site
  - Madrid, Spain, 28003
    - Recruiting
    - Clinical Site
  - Málaga, Spain, 29009
    - Recruiting
    - Clinical Site
  - Sabadell, Spain, 08208
    - Recruiting
    - Clinical Site
  - Santiago de Compostela, Spain, 15702
    - Recruiting
    - Clinical Site
  - Santiago de Compostela, Spain, 15706
    - Recruiting
    - Clinical Site
  - Seville, Spain, 41009
    - Recruiting
    - Clinical Site
  - Seville, Spain, 41010
    - Recruiting
    - Clinical Site
  - Seville, Spain, 41013
    - Recruiting
    - Clinical Site
  - Valencia, Spain, 46010
    - Recruiting
    - Clinical Site
United Kingdom
- - Barnet, United Kingdom, EN5 3DJ
    - Recruiting
    - Clinical Site
  - Leeds, United Kingdom, LS7 4SA
    - Recruiting
    - Clinical Site
- Essex
  - Westcliff-on-Sea, Essex, United Kingdom, SS0
    - Recruiting
    - Clinical Site
United States
- Arizona
  - Avondale, Arizona, United States, 85392
    - Recruiting
    - Clinical Site
  - Chandler, Arizona, United States, 85225
    - Completed
    - Clinical Site
  - Flagstaff, Arizona, United States, 86001
    - Completed
    - Clinical Site
  - Mesa, Arizona, United States, 85210
    - Recruiting
    - Clinical Site
  - Phoenix, Arizona, United States, 85032
    - Recruiting
    - Clinical Site
  - Scottsdale, Arizona, United States, 85260
    - Recruiting
    - Clinical Site
  - Tucson, Arizona, United States, 85748
    - Recruiting
    - Clinical Site
- Arkansas
  - Jonesboro, Arkansas, United States, 72401
    - Recruiting
    - Clinical Site
- California
  - La Jolla, California, United States, 92037
    - Recruiting
    - Clinical Site
  - Pomona, California, United States, 91767
    - Recruiting
    - Clinical Site
  - San Diego, California, United States, 92108
    - Recruiting
    - Clinical Site
  - Santa Monica, California, United States, 90404
    - Recruiting
    - Clinical Site
  - Thousand Oaks, California, United States, 91360
    - Recruiting
    - Clinical Site
  - Upland, California, United States, 91786
    - Recruiting
    - Clinical Site
- Florida
  - Avon Park, Florida, United States, 33825
    - Recruiting
    - Clinical Site
  - Clearwater, Florida, United States, 33765
    - Recruiting
    - Clinical Site
  - Hialeah, Florida, United States, 33016
    - Recruiting
    - Clinical Site
  - Miami Gardens, Florida, United States, 33014
    - Recruiting
    - Clinical Site
  - Tampa, Florida, United States, 33607
    - Recruiting
    - Clinical Site
  - Zephyrhills, Florida, United States, 33542
    - Recruiting
    - Clinical Site
- Georgia
  - Gainesville, Georgia, United States, 30501
    - Recruiting
    - Clinical Site
- Illinois
  - Springfield, Illinois, United States, 62702
    - Recruiting
    - Clinical Site
- Louisiana
  - Lake Charles, Louisiana, United States, 70605
    - Recruiting
    - Clinical Site
- Maryland
  - Baltimore, Maryland, United States, 21224-6821
    - Recruiting
    - Clinical Site
- Michigan
  - Grand Blanc, Michigan, United States, 48439-2451
    - Recruiting
    - Clinical Site
- New York
  - Brooklyn, New York, United States, 11201
    - Recruiting
    - Clinical Site
  - Rochester, New York, United States, 14642
    - Recruiting
    - Clinical Site
- North Carolina
  - Charlotte, North Carolina, United States, 28262
    - Recruiting
    - Clinical Site
  - Leland, North Carolina, United States, 28451
    - Recruiting
    - Clinical Site
- Ohio
  - Middleburg Heights, Ohio, United States, 44130
    - Recruiting
    - Clinical Site
- Oregon
  - Portland, Oregon, United States, 97239
    - Recruiting
    - Clinical Site
- Pennsylvania
  - Duncansville, Pennsylvania, United States, 16635
    - Recruiting
    - Clinical Site
- Tennessee
  - Jackson, Tennessee, United States, 38305
    - Recruiting
    - Clinical Site
  - Memphis, Tennessee, United States, 38119
    - Recruiting
    - Clinical Site
  - Murfreesboro, Tennessee, United States, 37128
    - Completed
    - Clinical Site
- Texas
  - Allen, Texas, United States, 75013
    - Completed
    - Clinical Site
  - Austin, Texas, United States, 78745
    - Recruiting
    - Clinical Site
  - Baytown, Texas, United States, 77521
    - Recruiting
    - Clinical Site
  - Colleyville, Texas, United States, 76034
    - Recruiting
    - Clinical Site
  - Houston, Texas, United States, 77089
    - Completed
    - Clinical Site
  - Lubbock, Texas, United States, 79424
    - Recruiting
    - Clinical Site
  - Plano, Texas, United States, 75024
    - Recruiting
    - Clinical Site
- Washington
  - Seattle, Washington, United States, 98122
    - Recruiting
    - Clinical Site
- West Virginia
  - Beckley, West Virginia, United States, 25801
    - Recruiting
    - 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

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Sonelokimab Sonelokimab
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.	Drug: Sonelokimab Sonelokimab
Placebo Comparator: Placebo Subjects randomized to this arm will receive placebo SC	Drug: Placebo Placebo
Active Comparator: risankizumab Subjects randomized to this arm will receive risankizumab SC	Drug: Risankizumab Active comparator

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 compared to placebo	Proportion of participants achieving ACR50	Week 16 compared to placebo

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 compared to placebo	Proportion of participants achieving ACR20	Week 16 compared to placebo
Response rate of participants achieving Minimal Disease Activity (MDA) Time Frame: Week 16 compared to placebo	Proportion of participants achieving MDA	Week 16 compared to placebo
Health Assessment Questionnaire- Disability Index (HAQ-DI) Time Frame: Week 16 compared to placebo	Change in HAQ-DI from baseline	Week 16 compared to placebo
Psoriasis Area and Severity Index (PASI90) Time Frame: Week 16 compared to placebo	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 compared to placebo
Short- form-36 (SF-36) Physical Component Summary (PCS) Time Frame: Week 16 compared to placebo	Change from Baseline in SF-36 PCS at Week 16	Week 16 compared to placebo
Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50) Time Frame: Week 16 compared to risankzumab	Proportion of participants achieving ACR50	Week 16 compared to risankzumab

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)

January 15, 2027

Study Completion (Estimated)

January 15, 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-302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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