An Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents Aged ≥12 to ≤17 Years at the Time of Study Inclusion With Active Moderate to Severe Hidradenitis Suppurativa
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a study to evaluate the pharmacokinetic (PK) and safety of sonelokimab in adolescent patients with HS.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:
• Participants must be between ≥12 and ≤17 years of age at the time of signing the informed consent.
• 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.
• Participants who have moderate to severe HS as determined by the refined Hurley staging (Stages IB and IC, IIB and IIC, and III).
• Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of HS .
• Participants must be up to date with age-appropriate vaccine requirements 8 weeks prior to entry in the study.
• Participants with a body weight of ≥ 40 kg.
Locations
United States
Arkansas
Clinical Site
RECRUITING
North Little Rock
California
Clinical Site
RECRUITING
Stanford
Washington, D.c.
Clinical Site
RECRUITING
Washington D.c.
Florida
Clinical Site
RECRUITING
Hollywood
Clinical Site
RECRUITING
Miami
Georgia
Clinical Site
RECRUITING
Macon
Clinical Site
RECRUITING
Sandy Springs
Illinois
Clinical Site
RECRUITING
Chicago
Indiana
Clinical Site
RECRUITING
Columbus
Kentucky
Clinical Site
RECRUITING
Murray
Michigan
Clinical Site
RECRUITING
Waterford
North Dakota
Clinical Site
RECRUITING
Fargo
South Carolina
Clinical Site
RECRUITING
Charleston
Texas
Clinical Site
RECRUITING
Dallas
Clinical Site
RECRUITING
Dallas
Clinical Site
RECRUITING
San Antonio
Virginia
Clinical Site
RECRUITING
Norfolk
Washington
Clinical Site
RECRUITING
Seattle
Contact Information
Primary
Moonlake Clinical Trial Helpdesk
ClinicalTrials@moonlaketx.com
+41 41 510 8022
Time Frame
Start Date:2024-12-30
Estimated Completion Date:2026-03-27
Participants
Target number of participants:35
Treatments
Experimental: 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