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

Phase 3Enrolling By InvitationNCT07007637

MoonLake Immunotherapeutics AG835 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

835

Conditions

Hidradenitis Suppurativa

Interventions

SonelokimabDRUG

Sonelokimab

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (23)

Clinical Site

Birmingham, Alabama, United States

Clinical Site

Northridge, California, United States

Outcomes

Primary Outcomes

Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab

Incidence, relatedness, severity and seriousness of all AEs

Time frame: 2.5-3 years

Long-term safety and tolerability of sonelokimab: Treatment emergent adverse events (TEAEs)

Incidence, relatedness, severity and seriousness of all TEAEs

Time frame: 2.5-3 years

Long-term safety and tolerability of sonelokimab: Adverse events of special interest (AESIs)

Incidence, relatedness, severity and seriousness of all AESIs

Time frame: 2.5-3 years

Long-term safety and tolerability of sonelokimab: Discontinuation of sonelokimab treatment due to AEs

Number of participants discontinued from sonelokimab treatment due to AEs

Time frame: 2.5-3 years

Long-term safety and tolerability of sonelokimab: Clinically significant changes in clinical laboratory parameters

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

Time frame: 2.5-3 years

Long-term safety and tolerability of sonelokimab: Clinically significant changes in vital signs and standard 12-lead electrocardiogram

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

Time frame: 2.5-3 years

Secondary Outcomes

Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

Data from ClinicalTrials.gov

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