RECRUITING

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

Conditions

Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial Suppuration Anti-Inflammatory Agents Sonelokimab Nanobody Apocrine Gland Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-12-30

Study Completion:2026-03-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06768671

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Moonlake Clinical Trial Helpdesk

CONTACT

+41 41 510 8022

ClinicalTrials@moonlaketx.com

Study Locations (Sites)

Clinical Site

Columbus, Indiana, 47201

United States

Collaborators and Investigators

Sponsor: MoonLake Immunotherapeutics AG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-30

Study Completion Date2026-03-27

Study Record Updates

Study Start Date2024-12-30

Study Completion Date2026-03-27

Terms related to this study

Keywords Provided by Researchers

Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Suppuration
Anti-Inflammatory Agents
Sonelokimab
Nanobody
Apocrine Gland Disease

Additional Relevant MeSH Terms

Hidradenitis Suppurativa