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 (88)

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

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Clinical Site

Birmingham, Alabama, United States

Clinical Site

North Little Rock, Arkansas, United States

Clinical Site

Los Angeles, California, United States

Clinical Site

Northridge, California, United States

Clinical Site

Aventura, Florida, United States

Clinical Site

Coral Gables, Florida, United States

Clinical Site

Hialeah, Florida, United States

Clinical Site

Hollywood, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Ocala, Florida, United States

...and 78 more locations