NCT07223138Enrolling by invitationPhase 3
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1560 (estimated)
- First submitted
- 20 Oct 2025
- Start date
- 13 Nov 2025
- Primary completion date
- 4 Feb 2028
- Lead sponsor
- MoonLake Immunotherapeutics AG
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT07223138
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1560
- From 13 Nov 2025 to the primary completion date, 4 Feb 2028
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who plan to participate in another interventional study for a drug or device during this study.
Other
- 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 were unblinded during the parental study.
- Participant noncompliance to the parental study
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Site Coordinator of this site? Confirm its status | Avondale | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Avon Park | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Baytown | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Duncansville | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Jonesboro | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Leland | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Lubbock | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Mesa | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Middleburg Heights | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Upland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.