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

June 10, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
960

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
      • Prague, Czechia, 140 59
        • 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
      • Athens, Greece, 12462
        • Clinical Site
      • 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
      • Klaipėda, Lithuania, LT-92288
        • Clinical Site
      • Vilnius, Lithuania, 01117
        • 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
      • Dębica, Poland, 39-200
        • Clinical Site
      • Elblag, Poland, 82-300
        • Clinical Site
      • Gdynia, Poland, 81-384
        • Clinical Site
      • Katowice, Poland, 40282
        • 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
      • Lodz, Poland, 90-368
        • 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
      • Poznan, Poland, 60-681
        • 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
      • Zamość, Poland, 22400
        • 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
      • Ponte de Lima, Portugal, 4990-041
        • 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
      • Niška Banja, Serbia, 18205
        • 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
      • Alcobendas, Spain, 28100
        • 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
      • Seville, Spain, 41007
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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