Clinical trial NCT06768671: An Open-label, Single-arm Study to Evaluate Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents With Moderate to Severe Hidradenitis Suppurativa (VELA-TEEN)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Suppuration
Anti-Inflammatory Agents
Sonelokimab
Nanobody
Apocrine Gland Disease
Lead sponsor: MoonLake Immunotherapeutics AG
Sponsor class: INDUSTRY
First posted: 2025-01-10
Enrollment: 35
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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 outcomes:
measure: Pharmacokinetics (PK) of sonelokimab in adolescents
timeFrame: Week 24
measure: Adverse events (AEs) following treatment with sonelokimab in adolescents
timeFrame: Week 24
measure: Discontinuation of sonelokimab treatment due to AEs
timeFrame: Week 24
measure: Clinically significant changes in clinical laboratory parameters
timeFrame: Week 24
measure: Clinically significant changes in vital signs
timeFrame: Week 24
measure: Clinically significant changes in standard 12-lead electrocardiogram (ECG) intervals
timeFrame: Week 24
Secondary outcomes:
measure: Hidradenitis Suppurativa Clinical Response (HiSCR)75
timeFrame: Week 24
measure: Hidradenitis Suppurativa Clinical Response (HiSCR) 50
timeFrame: Week 24
measure: International Hidradenitis Suppurativa Severity Score System (IHS4)
timeFrame: Week 24
measure: Children's Dermatology Life Quality Index (CDLQI)
timeFrame: Week 24
measure: Numerical Rating Scale (NRS) 30
timeFrame: Week 24
Other outcomes:
Locations:
city: Macon
country: United States
facility: Clinical Site
state: Georgia
city: Sandy Springs
country: United States
facility: Clinical Site
state: Georgia
city: Columbus
country: United States
facility: Clinical Site
state: Indiana
city: Murray
country: United States
facility: Clinical Site
state: Kentucky
city: Waterford
country: United States
facility: Clinical Site
state: Michigan
city: Fargo
country: United States
facility: Clinical Site
state: North Dakota
city: Dallas
country: United States
facility: Clinical Site
state: Texas
city: Plano
country: United States
facility: Clinical Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Site
state: Texas
city: Norfolk
country: United States
facility: Clinical Site
state: Virginia
Study officials:
References: