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Clinical Trials in the USA / NCT07223138
Enrolling by invitation Phase 3

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

NCT07223138 · tracked via the Priya Life Science USA tracker
Sponsor
MoonLake Immunotherapeutics AG
Phase
Phase 3
Started
2025-11-13
Last updated
2026-09-09

Condition(s) studied

Arthritis, Psoriatic

Investigational drug(s) / intervention(s)

Sonelokimab

Sonelokimab: Open-label

Study 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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
Clinical Site Avondale Arizona
Clinical Site Mesa Arizona
Clinical Site Phoenix Arizona
Clinical Site Scottsdale Arizona
Clinical Site Tucson Arizona
Clinical Site Jonesboro Arkansas
Clinical Site Upland California
Clinical Site Avon Park Florida
Clinical Site Clearwater Florida
Clinical Site Tampa Florida
Clinical Site Charlotte North Carolina
Clinical Site Leland North Carolina
Clinical Site Middleburg Heights Ohio
Clinical Site Duncansville Pennsylvania
Clinical Site Memphis Tennessee
Clinical Site Baytown Texas
Clinical Site Lubbock Texas

More MoonLake Immunotherapeutics AG trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07223138 on ClinicalTrials.gov ↗ ← All trials in the USA