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

September 8, 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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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-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

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.
1560

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 Contact Backup

  • Name: Prof Kristian Reich, M.D., Ph.D. (equ.)

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
      • Scottsdale, Arizona, United States, 85260
        • 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

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 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

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: Experimental: sonelokimab dose
All participants will receive sonelokimab subcutaneously every 4 weeks
Drug: Sonelokimab
Open-label

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
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

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
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

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.
November 13, 2025

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, 2028

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, 2028

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 20, 2025

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 28, 2025

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 31, 2025

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.
September 9, 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.
September 8, 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.
September 1, 2026

More Information

Terms related to this study

Keywords

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-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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