Loading clinical trials...

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

RECRUITINGPHASE3

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

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

NCT06768671•MoonLake Immunotherapeutics AG

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

12 - 17 years

Sex

ALL

Healthy Volunteers

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.

Locations (18)

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

Key Dates

Start Date

December 30, 2024

Primary Completion Date

March 27, 2026

Completion Date

March 27, 2026

Last Updated

December 15, 2025

Enrollment

ESTIMATED participants

Conditions

Hidradenitis Suppurativa

Interventions

Sonelokimab

DRUG

Contacts

Moonlake Clinical Trial Helpdesk

CONTACT

+41 41 510 8022 ClinicalTrials@moonlaketx.com

A Study With CIT-013 in HS Patients

NCT06993233

Hidradenitis Suppurativa (HS)

View study

RECRUITINGPHASE1

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

NCT06888193

Moderate to Severe Plaque PsoriasisPsoriatic Arthritis+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study With CIT-013 in HS Patients

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

Pelashield™ PainGuard™ vs Restrata® in HS Surgery

Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS) in Routine Clinical Practice in the Russian Federation

A 16-Week Study to Learn About the Study Medicine Called Ritlecitinib in Adults With Long Lasting Painful Red Skin Lumps, Known by the Medical Term, Hidradenitis Suppurativa, or HS.

1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)