An Open-label, Single-arm Study to Evaluate Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents With Moderate to Severe Hidradenitis Suppurativa (VELA-TEEN)
NCT ID: NCT06768671
Last Updated: 2025-12-15
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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RECRUITING
PHASE3
35 participants
INTERVENTIONAL
2024-12-30
2026-03-27
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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sonelokimab
Subjects will receive sonelokimab 120mg subcutaneously (SC) as an induction regimen of 4 doses, followed by sonelokimab SC every 4 weeks maintenance dose starting at Week 8
Sonelokimab
Open label
Interventions
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Sonelokimab
Open label
Eligibility Criteria
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Inclusion Criteria
2. Participants who are diagnosed with HS as determined by the investigator and have a history of signs and symptoms of HS for ≥6 months before signing the informed consent.
3. Participants who have moderate to severe HS as determined by the refined Hurley staging (Stages IB and IC, IIB and IIC, and III).
4. Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of HS .
5. Participants must be up to date with age-appropriate vaccine requirements 8 weeks prior to entry in the study.
6. Participants with a body weight of ≥ 40 kg.
Exclusion Criteria
2. Participants with a draining fistula count of ≥20 at the Screening Visit.
3. Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
4. Participants with underlying conditions that, in the opinion of the investigator, potentially compromise the participant and/or places the participant at unacceptable risk.
5. Participants who have history or concurrent clinically significant medical conditions or any other reason, including any physical, psychological, or psychiatric condition, that in the opinion of the investigator would compromise the safety or interfere with participation in the study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk.
6. Participants with any other skin disease or other medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS.
7. Participants with a confirmed or suspected diagnosis of inflammatory bowel disease.
12 Years
17 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
North Little Rock, Arkansas, United States
Clinical Site
Stanford, California, United States
Clinical Site
Washington D.C., District of Columbia, United States
Clinical Site
Hollywood, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Macon, Georgia, United States
Clinical Site
Sandy Springs, Georgia, United States
Clinical Site
Chicago, Illinois, United States
Clinical Site
Columbus, Indiana, United States
Clinical Site
Murray, Kentucky, United States
Clinical Site
Waterford, Michigan, United States
Clinical Site
Fargo, North Dakota, United States
Clinical Site
Charleston, South Carolina, United States
Clinical Site
Dallas, Texas, United States
Clinical Site
Dallas, Texas, United States
Clinical Site
San Antonio, Texas, United States
Clinical Site
Norfolk, Virginia, United States
Clinical Site
Seattle, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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M1095-HS-304
Identifier Type: -
Identifier Source: org_study_id
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