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

Phase 3

• Conditions: Hidradenitis Suppurativa
• Interventions: Drug: Sonelokimab

• Registration Number: NCT07007637
• Lead Sponsor: MoonLake Immunotherapeutics AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-05-28
• Study First Posted: 2025-06-06
• Study Start: 2025-06-27
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-04
• Primary Completion: 2028-06-13
• Study Completion: 2028-06-13

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 835

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: sonelokimab	Sonelokimab	All participants will receive sonelokimab 120 mg Q4W for up to 2 years

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) and 50 (HiSCR50)	2.5 - 3 years	Percentage of participants achieving a HiSCR90 and HiSCAR50 response over time
Long-term efficacy of sonelokimab: International Hidradenitis Suppurativa Severity Score System (IHS4)	2.5 - 3 years	Absolute change in IHS4 score over time
Long-term efficacy of sonelokimab: Number of abscesses, draining fistulas/tunnels; inflammatory nodules	2.5 - 3 years	Absolute change in number of abscesses, draining fistulas/tunnels; inflammatory nodules
Long-term efficacy of sonelokimab: Dermatology Life Quality Index (DLQI)	2.5 - 3 years	Change in DLQI total score
Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Quality of Life (HiSQOL)	2.5 - 3 years	Change in HiSQOL total score
Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)	2.5 - 3 years	Percentage of participants achieving a HiSCR75 response over time

Trial Locations

Locations (1)

Clinical Site; 🇺🇸 Birmingham, Alabama, United States