An Open-label, Single-arm Study to Evaluate Pharmacokinetics and Safety of Subcutaneous Sonelokim… (NCT06768671) | Clinical Trial Compass
Active — Not RecruitingPhase 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)
United States35 participantsStarted 2024-12-30
Plain-language summary
This is a study to evaluate the pharmacokinetic (PK) and safety of sonelokimab in adolescent patients with HS.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Participants with a known hypersensitivity to sonelokimab or any of its excipients.
. Participants with a draining fistula count of ≥20 at the Screening Visit.
. Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pharmacokinetics (PK) of sonelokimab in adolescents
Timeframe: Week 24
2
Adverse events (AEs) following treatment with sonelokimab in adolescents
Timeframe: Week 24
3
Discontinuation of sonelokimab treatment due to AEs
Timeframe: Week 24
4
Clinically significant changes in clinical laboratory parameters
Timeframe: Week 24
5
Clinically significant changes in vital signs
Timeframe: Week 24
6
Clinically significant changes in standard 12-lead electrocardiogram (ECG) intervals
. Participants with underlying conditions that, in the opinion of the investigator, potentially compromise the participant and/or places the participant at unacceptable risk.
. 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.
. 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.
. Participants with a confirmed or suspected diagnosis of inflammatory bowel disease.