A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa
NCT ID: NCT07007637
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE3
835 participants
INTERVENTIONAL
2025-06-27
2028-06-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental: sonelokimab
All participants will receive sonelokimab 120 mg Q4W for up to 2 years
Sonelokimab
Sonelokimab
Interventions
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Sonelokimab
Sonelokimab
Eligibility Criteria
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Inclusion Criteria
* 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 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.
12 Years
ALL
No
Sponsors
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MoonLake Immunotherapeutics AG
INDUSTRY
Responsible Party
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Locations
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Clinical Site
Birmingham, Alabama, United States
Clinical Site
Northridge, California, United States
Clinical Site
North Miami Beach, Florida, United States
Clinical Site
Macon, Georgia, United States
Clinical Site
Sandy Springs, Georgia, United States
Clinical Site
Columbus, Indiana, United States
Clinical Site
New Albany, Indiana, United States
Clinical Site
Murray, Kentucky, United States
Clinical Site
Canton, Michigan, United States
Clinical Site
Clarkston, Michigan, United States
Clinical Site
Waterford, Michigan, United States
Clinical Site
New Brighton, Minnesota, United States
Clinical Site
Omaha, Nebraska, United States
Clinical Site
Murfreesboro, Tennessee, United States
Clinical Site
Dallas, Texas, United States
Clinical Site
San Antonio, Texas, United States
Clinical Site
Fredericton, New Brunswick, Canada
Clinical Site
Barrie, Ontario, Canada
Clinical Site
Guelph, Ontario, Canada
Clinical Site
Markham, Ontario, Canada
Clinical Site
Peterborough, Ontario, Canada
Clinical Site
Toronto, Ontario, Canada
Clinical Site
Saskatoon, Saskatchewan, Canada
Countries
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Other Identifiers
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VELA-OLE
Identifier Type: OTHER
Identifier Source: secondary_id
M1095-HS-303
Identifier Type: -
Identifier Source: org_study_id
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