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

NCT06768671 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: M1095-HS-304
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 18

Brief Summary

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

Conditions

Hidradenitis Suppurativa

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Pharmacokinetics (PK) of sonelokimab in adolescents

  PK (trough concentrations) of sonelokimab over 24 weeks of treatment

  Week 24

• Adverse events (AEs) following treatment with sonelokimab in adolescents

  Incidence, relatedness, severity and seriousness of all AEs over 24 weeks of treatment from baseline

  Week 24

• Discontinuation of sonelokimab treatment due to AEs

  Number of participants discontinued from sonelokimab treatment due to AE over 24 weeks of treatment from baseline

  Week 24

• Clinically significant changes in clinical laboratory parameters

  Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline

  Week 24

• Clinically significant changes in vital signs

  Number of participants with clinically significant changes in vital signs from baseline

  Week 24

• Clinically significant changes in standard 12-lead electrocardiogram (ECG) intervals

  Number of participants with clinically significant changes in 12-lead ECG intervals from baseline

  Week 24

Secondary Outcomes (5)

• Hidradenitis Suppurativa Clinical Response (HiSCR)75

  Week 24

• Hidradenitis Suppurativa Clinical Response (HiSCR) 50

  Week 24

• International Hidradenitis Suppurativa Severity Score System (IHS4)

  Week 24

• Children's Dermatology Life Quality Index (CDLQI)

  Week 24

• Numerical Rating Scale (NRS) 30

  Week 24

Study Arms (1)

sonelokimab

EXPERIMENTAL

Subjects will receive sonelokimab 120mg subcutaneously (SC) as an induction regimen of 4 doses, followed by sonelokimab SC every 4 weeks maintenance dose starting at Week 8

Drug: Sonelokimab

Interventions

Sonelokimab DRUG

Open label

sonelokimab

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• MoonLake Immunotherapeutics AG: lead

Study Sites (18)

Clinical Site

North Little Rock, Arkansas, 72117, United States

Location

Clinical Site

Stanford, California, 94304, United States

Location

Clinical Site

Washington D.C., District of Columbia, 20010, United States

Location

Clinical Site

Hollywood, Florida, 33201, United States

Location

Clinical Site

Miami, Florida, 33136, United States

Location

Clinical Site

Macon, Georgia, 31217, United States

Location

Clinical Site

Sandy Springs, Georgia, 30328, United States

Location

Clinical Site

Chicago, Illinois, 60611, United States

Location

Clinical Site

Columbus, Indiana, 47201, United States

Location

Clinical Site

Murray, Kentucky, 42071, United States

Location

Clinical Site

Waterford, Michigan, 48328, United States

Location

Clinical Site

Fargo, North Dakota, 58103, United States

Location

Clinical Site

Charleston, South Carolina, 29425, United States

Location

Clinical Site

Dallas, Texas, 75246, United States

Location

Clinical Site

Dallas, Texas, 75390-8575, United States

Location

Clinical Site

San Antonio, Texas, 78218, United States

Location

Clinical Site

Norfolk, Virginia, 23502, United States

Location

Clinical Site

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa; Hidradenitis; Sweat Gland Diseases; Skin Diseases; Skin Diseases, Bacterial; Suppuration

Interventions

sonelokimab

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: January 10, 2025
• Study Start: December 30, 2024
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): September 28, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (18)