A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa

NCT07007637 · tracked via the Priya Life Science UK tracker

Sponsor

MoonLake Immunotherapeutics AG

Phase

Phase 3

Started

2025-06-27

Last updated

2026-06-08

Condition(s) studied

Hidradenitis Suppurativa

Investigational drug(s) / intervention(s)

Sonelokimab

Sonelokimab: Sonelokimab

Study summary

This is a study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe hidradenitis suppurativa who were previously enrolled in a parental study.

Eligibility

Sex

ALL

Min age

12 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Participants who have completed a parental study (M1095-HS-301 or M1095-HS-302 \[adult studies\] or M1095-HS-304 \[adolescent study\]) and are eligible to continue to receive sonelokimab at the time of completing the parental study. * Female participants are eligible to participate if they are not pregnant or breastfeeding * Male participants must be willing to use a condom when sexually active with a partner of childbearing potential . Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment. Exclusion Criteria: * Participants who meet any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study. * Participants who have ongoing or planned to use one or more of the prohibited HS or non-HS treatments specified in the protocol. * Participants who plan to participate in another interventional study for a drug or device during this study.

Primary outcome measure(s)

Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab — 2.5-3 years
Incidence, relatedness, severity and seriousness of all AEs
Long-term safety and tolerability of sonelokimab: Treatment emergent adverse events (TEAEs) — 2.5-3 years
Incidence, relatedness, severity and seriousness of all TEAEs
Long-term safety and tolerability of sonelokimab: Adverse events of special interest (AESIs) — 2.5-3 years
Incidence, relatedness, severity and seriousness of all AESIs
Long-term safety and tolerability of sonelokimab: Discontinuation of sonelokimab treatment due to AEs — 2.5-3 years
Number of participants discontinued from sonelokimab treatment due to AEs
Long-term safety and tolerability of sonelokimab: Clinically significant changes in clinical laboratory parameters — 2.5-3 years
Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline
Long-term safety and tolerability of sonelokimab: Clinically significant changes in vital signs and standard 12-lead electrocardiogram — 2.5-3 years
Number of participants with clinically significant changes in vital signs and 12-lead ECG intervals from baseline

Trial sites (166)

Facility	City	Region
Clinical Site	Birmingham	Alabama
Clinical Site	North Little Rock	Arkansas
Clinical Site	Los Angeles	California
Clinical Site	Northridge	California
Clinical Site	Aventura	Florida
Clinical Site	Coral Gables	Florida
Clinical Site	Hialeah	Florida
Clinical Site	Hollywood	Florida
Clinical Site	Miami	Florida
Clinical Site	Miami	Florida
Clinical Site	Ocala	Florida
Clinical Site	Tampa	Florida
Clinical Site	Tampa	Florida
Clinical Site	Macon	Georgia
Clinical Site	Sandy Springs	Georgia
Clinical Site	Skokie	Illinois
Clinical Site	West Dundee	Illinois
Clinical Site	Columbus	Indiana
Clinical Site	New Albany	Indiana
Clinical Site	Plainfield	Indiana
Clinical Site	Louisville	Kentucky
Clinical Site	Murray	Kentucky
Clinical Site	Metairie	Louisiana
Clinical Site	Boston	Massachusetts
Clinical Site	Boston	Massachusetts
Clinical Site	Ann Arbor	Michigan
Clinical Site	Canton	Michigan
Clinical Site	Clarkston	Michigan
Clinical Site	Waterford	Michigan
Clinical Site	New Brighton	Minnesota
Clinical Site	Omaha	Nebraska
Clinical Site	Las Vegas	Nevada
Clinical Site	New York	New York
Clinical Site	New York	New York
Clinical Site	The Bronx	New York
Clinical Site	Fargo	North Dakota
Clinical Site	Boardman	Ohio
Clinical Site	Columbus	Ohio
Clinical Site	Dayton	Ohio
Clinical Site	Oklahoma City	Oklahoma

+ 126 more sites — see the full list on the official registry below.

More MoonLake Immunotherapeutics AG trials in the UK

Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response Recruiting

Other trials for the same condition

A Real World Study to Globally Assess Disease Burden in Adolescent and Adult Participants With Alopecia Areata, Vitiligo, or Hidradenitis Suppurativa Recruiting

Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa Recruiting

Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012) Active, not recruiting

A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy Active, not recruiting

A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07007637 on ClinicalTrials.gov ↗ ← All trials in the UK