A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis

June 10, 2026 updated by: MoonLake Immunotherapeutics AG
This is a study to demonstrate the long-term safety, tolerability and clinical efficacy of sonelokimab in the treatment of patients with psoriatic arthritis who completed a parental study (M1095-PSA-301 or M1095-PSA-302)

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

M1095-PSA-303 is a Phase 3, multicenter, open-label extension study to investigate the long-term safety, tolerability and clinical efficacy of sonelokimab 60 mg subcutaneously every 4 weeks in patients with psoriatic arthritis who completed a parental study (M1095-PSA-301 or M1095-PSA-302).

Study Type

Interventional

Enrollment (Estimated)

1560

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

  • United States
    • Arizona
      • Avondale, Arizona, United States, 85392
        • Clinical Site
      • Mesa, Arizona, United States, 85210
        • Clinical Site
      • Phoenix, Arizona, United States, 85032
        • Clinical Site
      • Tucson, Arizona, United States, 85748
        • Clinical Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Clinical Site
    • California
      • Upland, California, United States, 91786
        • Clinical Site
    • Florida
      • Avon Park, Florida, United States, 33825
        • Clinical Site
      • Clearwater, Florida, United States, 33765
        • Clinical Site
      • Tampa, Florida, United States, 33607
        • Clinical Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28262
        • Clinical Site
      • Leland, North Carolina, United States, 28451
        • Clinical Site
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Clinical Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Clinical Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Site
    • Texas
      • Baytown, Texas, United States, 77521
        • Clinical Site
      • Lubbock, Texas, United States, 79424
        • 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 who, in the opinion of the investigator, are expected to benefit from participation in this OLE study.
  2. Participants who have received the second to last and/or last dose, as planned in the parental study, and have completed the end-of-treatment visit of the parental study.
  3. Participants must have received their last dose of study treatment in the parental study no more than 8 weeks (but ideally 4 weeks) before the first dose in this OLE study.
  4. Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential or must agree to use highly effective methods of contraception during the study and for at least 8 weeks after the last dose of study treatment. Female participant of childbearing potential must refrain from donating oocytes during the study and for at least 8 weeks after the last dose of study treatment.
  5. Male participants must be willing to use a condom when sexually active with a partner of childbearing potential during the study and for at least 8 weeks after the last dose of study treatment, unless surgically sterile. Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment.

Exclusion Criteria:

  1. Participants who met any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study.
  2. Participants who have ongoing or planned use of one or more of the prohibited PsA or non-PsA treatments specified in this protocol.
  3. Participants who plan to participate in another interventional study for a drug or device during this study.
  4. Participants who were unblinded during the parental study.
  5. Participant noncompliance to the parental study

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: sonelokimab dose
All participants will receive sonelokimab subcutaneously every 4 weeks
Drug: Sonelokimab
Open-label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term safety and tolerability of sonelokimab:
Time Frame: 52 weeks
Treatment-emergent adverse events (TEAEs)
52 weeks
Long-term safety and tolerability of sonelokimab:
Time Frame: 52 weeks
Serious adverse events (SAEs)
52 weeks
Long-term safety and tolerability of sonelokimab:
Time Frame: 52 weeks
TEAEs leading to study withdrawal
52 weeks
Long-term safety and tolerability of sonelokimab:
Time Frame: 52 weeks
Adverse events of special interest (AESIs)
52 weeks
Long-term safety and tolerability of sonelokimab:
Time Frame: 52 weeks
Clinically significant changes in vital signs and standard 12-lead electrocardiogram Measure description: Number of participants with clinically significant changes in vital signs and 12-lead ECG intervals from baseline
52 weeks
Long-term safety and tolerability of sonelokimab:
Time Frame: 52 weeks
Clinically significant changes in clinical laboratory parameters Measure description: Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term efficacy of sonelokimab:
Time Frame: 52 weeks
Proportion of participants achieving American College of Rheumatology (ACR) 20/50/70% improvement criteria over time
52 weeks
Long-term efficacy of sonelokimab:
Time Frame: 52 weeks
Change over time in Minimal disease activity (MDA)
52 weeks
Long-term efficacy of sonelokimab:
Time Frame: 52 weeks
Change over time in Health assessment questionnaire-disability index (HAQ-DI)
52 weeks
Long-term efficacy of sonelokimab:
Time Frame: 52 weeks
Change over time in Tender joint count (TJC)68/ swollen joint count (SJC)66
52 weeks
Long-term efficacy of sonelokimab:
Time Frame: 52 weeks
Proportion of participants achieving Psoriasis Area and Severity Index (PASI) 75/90/100 over time
52 weeks
Long-term efficacy of sonelokimab:
Time Frame: 52 weeks
Change over time in Modified Nail Psoriasis Severity Index (mNAPSI)
52 weeks
Long-term efficacy of sonelokimab:
Time Frame: 52 weeks
Proportion of participants achieving Very low disease activity (VLDA) over time
52 weeks
Long-term efficacy of sonelokimab:
Time Frame: 52 weeks
Proportion of participants achieving SpondyloArthritis Research Consortium of Canada (SPARCC) over time
52 weeks
Long-term efficacy of sonelokimab:
Time Frame: 52 weeks
Change over time in Leeds Enthesitis Index (LEI)
52 weeks
Long term efficacy of sonelokimab
Time Frame: 52 weeks
Proportion of participants achieving both an ACR 50/ACR70 and PASI90/100 improvement over time
52 weeks

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)

November 13, 2025

Primary Completion (Estimated)

February 4, 2028

Study Completion (Estimated)

February 4, 2028

Study Registration Dates

First Submitted

October 20, 2025

First Submitted That Met QC Criteria

October 28, 2025

First Posted (Actual)

October 31, 2025

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M1095-PSA-303
  • IZAR-OLE (Other Identifier: Sponsor)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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