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Enrolling By Invitation
NCT07007637
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa
Conditions: Hidradenitis Suppurativa
Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 835
Sponsor: MoonLake Immunotherapeutics AG
Location: Clinical Site Birmingham Alabama
Summary
This is a study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe hidradenitis suppurativa who were previously enrolled in a parental study.
Eligibility Criteria
Inclusion Criteria:
* Participants who have completed a parental study (M1095-HS-301 or M1095-HS-302 \[adult studies\] or M1095-HS-304 \[adolescent study\]) and are eligible to continue to receive sonelokimab at the time of completing the parental study.
* Female participants are eligible to participate if they are not pregnant or breastfeeding
* Male participants must be willing to use a condom when sexually active with a partner of childbearing potential . 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:
* Participants who meet any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study.
* Participants who have ongoing or planned to use one or more of the prohibited HS or non-HS treatments specified in the protocol.
* Participants who plan to participate in another interventional study for a drug or device during this study.
Source: ClinicalTrials.gov (NCT07007637). StuddyBuddy aggregates publicly available trial information.