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 range12 Years – 17 Years
SexALL
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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.
✕. 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.
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 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.