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Active, not recruiting Phase 3

An Open-label, Single-arm Study to Evaluate Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents With Moderate to Severe Hidradenitis Suppurativa (VELA-TEEN)

NCT06768671 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2024-12-30
Last updated
2026-05-06

Condition(s) studied

Hidradenitis Suppurativa

Investigational drug(s) / intervention(s)

Sonelokimab →

Sonelokimab: Open label

Study summary

This is a study to evaluate the pharmacokinetic (PK) and safety of sonelokimab in adolescent patients with HS.

Eligibility

Sex
ALL
Min age
12 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: 1. Participants must be between ≥12 and ≤17 years of age at the time of signing the informed consent. 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: 1. Participants with a known hypersensitivity to sonelokimab or any of its excipients. 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.

Primary outcome measure(s)

  • Pharmacokinetics (PK) of sonelokimab in adolescents — Week 24
    PK (trough concentrations) of sonelokimab over 24 weeks of treatment
  • Adverse events (AEs) following treatment with sonelokimab in adolescents — Week 24
    Incidence, relatedness, severity and seriousness of all AEs over 24 weeks of treatment from baseline
  • Discontinuation of sonelokimab treatment due to AEs — Week 24
    Number of participants discontinued from sonelokimab treatment due to AE over 24 weeks of treatment from baseline
  • Clinically significant changes in clinical laboratory parameters — Week 24
    Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline
  • Clinically significant changes in vital signs — Week 24
    Number of participants with clinically significant changes in vital signs from baseline
  • Clinically significant changes in standard 12-lead electrocardiogram (ECG) intervals — Week 24
    Number of participants with clinically significant changes in 12-lead ECG intervals from baseline

Trial sites (18)

FacilityCityRegionStatus
Clinical Site North Little Rock Arkansas
Clinical Site Stanford California
Clinical Site Washington D.C. District of Columbia
Clinical Site Hollywood Florida
Clinical Site Miami Florida
Clinical Site Macon Georgia
Clinical Site Sandy Springs Georgia
Clinical Site Chicago Illinois
Clinical Site Columbus Indiana
Clinical Site Murray Kentucky
Clinical Site Waterford Michigan
Clinical Site Fargo North Dakota
Clinical Site Charleston South Carolina
Clinical Site Dallas Texas
Clinical Site Dallas Texas
Clinical Site San Antonio Texas
Clinical Site Norfolk Virginia
Clinical Site Seattle Washington
Official registry record

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.

View NCT06768671 on ClinicalTrials.gov ↗ ← All trials in the USA