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Enrolling by Invitation

NCT Number: NCT07223138

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

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)

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Key information

Conditions

Arthritis, Psoriatic Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Site, Avondale, Arizona, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who, in the opinion of the investigator, are expected to benefit from participation in this OLE study.
  • 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.
  • 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.
  • 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.
  • 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

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

Treatment and study plan

Sonelokimab

Drug

Open-label

Primary outcomes

  1. Long-term safety and tolerability of sonelokimab:

    Time frame: 52 weeks

    Treatment-emergent adverse events (TEAEs)

  2. Long-term safety and tolerability of sonelokimab:

    Time frame: 52 weeks

    Serious adverse events (SAEs)

  3. Long-term safety and tolerability of sonelokimab:

    Time frame: 52 weeks

    TEAEs leading to study withdrawal

  4. Long-term safety and tolerability of sonelokimab:

    Time frame: 52 weeks

    Adverse events of special interest (AESIs)

  5. 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

  6. 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

Secondary outcomes

  1. 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

  2. Long-term efficacy of sonelokimab:

    Time frame: 52 weeks

    Change over time in Minimal disease activity (MDA)

  3. Long-term efficacy of sonelokimab:

    Time frame: 52 weeks

    Change over time in Health assessment questionnaire-disability index (HAQ-DI)

  4. Long-term efficacy of sonelokimab:

    Time frame: 52 weeks

    Change over time in Tender joint count (TJC)68/ swollen joint count (SJC)66

  5. Long-term efficacy of sonelokimab:

    Time frame: 52 weeks

    Proportion of participants achieving Psoriasis Area and Severity Index (PASI) 75/90/100 over time

  6. Long-term efficacy of sonelokimab:

    Time frame: 52 weeks

    Change over time in Modified Nail Psoriasis Severity Index (mNAPSI)

  7. Long-term efficacy of sonelokimab:

    Time frame: 52 weeks

    Proportion of participants achieving Very low disease activity (VLDA) over time

  8. Long-term efficacy of sonelokimab:

    Time frame: 52 weeks

    Proportion of participants achieving SpondyloArthritis Research Consortium of Canada (SPARCC) over time

  9. Long-term efficacy of sonelokimab:

    Time frame: 52 weeks

    Change over time in Leeds Enthesitis Index (LEI)

  10. Long term efficacy of sonelokimab

    Time frame: 52 weeks

    Proportion of participants achieving both an ACR 50/ACR70 and PASI90/100 improvement over time

Sponsors and collaborators

Lead sponsor

MoonLake Immunotherapeutics AG

Industry

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 31, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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