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)
Long-term safety and tolerability of sonelokimab: — 52 weeks Treatment-emergent adverse events (TEAEs)
Long-term safety and tolerability of sonelokimab: — 52 weeks Serious adverse events (SAEs)
Long-term safety and tolerability of sonelokimab: — 52 weeks TEAEs leading to study withdrawal
Long-term safety and tolerability of sonelokimab: — 52 weeks Adverse events of special interest (AESIs)
Long-term safety and tolerability of sonelokimab: — 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
Long-term safety and tolerability of sonelokimab: — 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
Trial sites (17)
Facility
City
Region
Status
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
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.
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