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

NCT07223138
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Enrolling by invitation
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Participants
1,560
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Lead sponsor
MoonLake Immunotherapeutics AG
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Start date
2025-11-13
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Number of sites
16
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Summary
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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Short title
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis
clinicaltrials.gov
Official title
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis
clinicaltrials.gov

Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Enrolling by invitation
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-02-04
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First posted
2025-10-31
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Registry last updated
2026-06-11
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Primary completion date
2028-02-04
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Start date
2025-11-13
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Participants
1,560
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Participant count basis
Estimated
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Planned participants
1,560
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Protocol amendments
0
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Number of sites
16
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
MoonLake Immunotherapeutics AG
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07223138
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ClinicalTrials.gov ID
NCT07223138
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Long-term safety and tolerability of sonelokimab:

    Timeframe: 52 weeks

    Treatment-emergent adverse events (TEAEs)

  2. Long-term safety and tolerability of sonelokimab:

    Timeframe: 52 weeks

    Serious adverse events (SAEs)

  3. Long-term safety and tolerability of sonelokimab:

    Timeframe: 52 weeks

    TEAEs leading to study withdrawal

  4. Long-term safety and tolerability of sonelokimab:

    Timeframe: 52 weeks

    Adverse events of special interest (AESIs)

  5. Long-term safety and tolerability of sonelokimab:

    Timeframe: 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:

    Timeframe: 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

  1. Long-term efficacy of sonelokimab:

    Timeframe: 52 weeks

    Proportion of participants achieving American College of Rheumatology (ACR) 20/50/70% improvement criteria over time

  2. Long-term efficacy of sonelokimab:

    Timeframe: 52 weeks

    Change over time in Minimal disease activity (MDA)

  3. Long-term efficacy of sonelokimab:

    Timeframe: 52 weeks

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

  4. Long-term efficacy of sonelokimab:

    Timeframe: 52 weeks

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

  5. Long-term efficacy of sonelokimab:

    Timeframe: 52 weeks

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

  6. Long-term efficacy of sonelokimab:

    Timeframe: 52 weeks

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

  7. Long-term efficacy of sonelokimab:

    Timeframe: 52 weeks

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

  8. Long-term efficacy of sonelokimab:

    Timeframe: 52 weeks

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

  9. Long-term efficacy of sonelokimab:

    Timeframe: 52 weeks

    Change over time in Leeds Enthesitis Index (LEI)

  10. Long term efficacy of sonelokimab

    Timeframe: 52 weeks

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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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.

  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
Sources for eligibility
clinicaltrials.gov

  • Clinical SiteAvondale, United States
  • Clinical SiteMesa, United States
  • Clinical SitePhoenix, United States
  • Clinical SiteTucson, United States
  • Clinical SiteJonesboro, United States
  • Clinical SiteUpland, United States
  • Clinical SiteAvon Park, United States
  • Clinical SiteClearwater, United States
  • Clinical SiteTampa, United States
  • Clinical SiteCharlotte, United States
  • Clinical SiteLeland, United States
  • Clinical SiteMiddleburg Heights, United States
  • Clinical SiteDuncansville, United States
  • Clinical SiteMemphis, United States
  • Clinical SiteBaytown, United States
  • Clinical SiteLubbock, United States
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • IZAR-OLE
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (2)