Clinical Trials in the USA / NCT06768671
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
Condition(s) studied
Hidradenitis Suppurativa
Study summary
This is a study to evaluate the pharmacokinetic (PK) and safety of sonelokimab in adolescent patients with HS.
Eligibility
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More MoonLake Immunotherapeutics AG trials in the USA
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
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A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa
Enrolling by invitation
Other trials for the same condition
Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)
Active, not recruiting
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa
Enrolling by invitation
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