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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: Sonelokimab

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Clinical Site
  • California
    • Stanford, California, United States, 94304
      • Clinical Site
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Clinical Site
  • Florida
    • Hollywood, Florida, United States, 33201
      • Clinical Site
    • Miami, Florida, United States, 33136
      • Clinical Site
  • Georgia
    • Macon, Georgia, United States, 31217
      • Clinical Site
    • Sandy Springs, Georgia, United States, 30328
      • Clinical Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Clinical Site
  • Indiana
    • Columbus, Indiana, United States, 47201
      • Clinical Site
  • Kentucky
    • Murray, Kentucky, United States, 42071
      • Clinical Site
  • Michigan
    • Waterford, Michigan, United States, 48328
      • Clinical Site
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Clinical Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Clinical Site
  • Texas
    • Dallas, Texas, United States, 75246
      • Clinical Site
    • Dallas, Texas, United States, 75390-8575
      • Clinical Site
    • San Antonio, Texas, United States, 78218
      • Clinical Site
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Clinical Site
  • Washington
    • Seattle, Washington, United States, 98105
      • Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sonelokimab; 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; Open label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hidradenitis Suppurativa Clinical Response (HiSCR)75	Percentage of participants achieving a HiSCR75 response over time	Week 24
Hidradenitis Suppurativa Clinical Response (HiSCR) 50	Percentage of participants achieving a HiSCR50 response over time	Week 24
International Hidradenitis Suppurativa Severity Score System (IHS4)	Absolute change in IHS4 score over time	Week 24
Children's Dermatology Life Quality Index (CDLQI)	Percentage of participants achieving a CDLQI total reduction of ≥2.5 over time among participants with a baseline CDLQI ≥2.5	Week 24
Numerical Rating Scale (NRS) 30	Percentage of participants achieving a ≥30% reduction and a ≥2-unit reduction over time in the NRS30 for pain in PGA among participants with a baseline NRS ≥3	Week 24

Collaborators and Investigators

• Sponsor: MoonLake Immunotherapeutics AG

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): September 28, 2026

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Skin Diseases; Anti-Inflammatory Agents; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis; Sweat Gland Diseases; Suppuration; Sonelokimab; Nanobody; Apocrine Gland Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa; Hidradenitis; Skin Diseases; Skin Diseases, Bacterial; Sweat Gland Diseases; Suppuration; sonelokimab
• Other Study ID Numbers: M1095-HS-304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No