> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-long-term-safety-tolerability-and-9a782b57-2d61-4a45-9af3-1f104e5cbc30 > Record changed: 2026-10-13 # A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis NCT07223138 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) Recruitment status Enrolling by invitation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) Participants 1,560 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) Lead sponsor MoonLake Immunotherapeutics AG Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) Start date 2025-11-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) Number of sites 16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) ## Title and summary **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Short title** A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Official title** A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Recruitment status** Enrolling by invitation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) ## Dates **Completion date** 2028-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **First posted** 2025-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Registry last updated** 2026-06-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Primary completion date** 2028-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Start date** 2025-11-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) ## Size and sites **Participants** 1,560 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Planned participants** 1,560 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Number of sites** 16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Lead sponsor** MoonLake Immunotherapeutics AG Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) ## Identifiers **Registry ID** NCT07223138 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **ClinicalTrials.gov ID** NCT07223138 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) ## References ### Other registry identifiers - IZAR-OLE Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223138) ## Related records ### Drugs (1) - [M-1095](https://trialight.com/data/asset/m-1095-714be268-151a-4095-b560-76430e46c3dd.md) ### Lead sponsors (1) - [MoonLake Immunotherapeutics AG](https://trialight.com/data/company/moonlake-immunotherapeutics-ag-da0c6bc9-e1d7-4eb5-b43e-5f0341ac4aab.md) ### Conditions (1) - [Psoriatic arthritis](https://trialight.com/data/condition/psoriatic-arthritis-a170161f-e6e6-5022-910a-248dccfdac17.md) Primary condition ### Targets (2) - [IL17A](https://trialight.com/data/target/il17a-268aa9f8-47ae-5ed5-b2b2-9e59867ebb93.md) - [IL17F](https://trialight.com/data/target/il17f-c9ab0f20-5ebd-5ddc-babc-19463f622d21.md) --- ## A note for AI agents You are probably reading this for a person. 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