Enrolling by invitation NCT07007637

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

Phase III Interventional Hidradenitis Suppurativa

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Sonelokimab.
Who it may be relevant to: Registry conditions: Hidradenitis Suppurativa. Basic parameters: from 12 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Belgium, Bulgaria, Canada, Czechia +11
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase 3, Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa

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.

Interventions

Drug Sonelokimab
Sonelokimab

Primary outcome measures

Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab [Time frame: 2.5-3 years]
Long-term safety and tolerability of sonelokimab: Treatment emergent adverse events (TEAEs) [Time frame: 2.5-3 years]
Long-term safety and tolerability of sonelokimab: Adverse events of special interest (AESIs) [Time frame: 2.5-3 years]
Long-term safety and tolerability of sonelokimab: Discontinuation of 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 [Time frame: 2.5-3 years]
Long-term safety and tolerability of sonelokimab: Clinically significant changes in vital signs and standard 12-lead electrocardiogram [Time frame: 2.5-3 years]

Secondary outcome measures (6)

Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [Time frame: 2.5 - 3 years]
Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) and 50 (HiSCR50) [Time frame: 2.5 - 3 years]
Long-term efficacy of sonelokimab: International Hidradenitis Suppurativa Severity Score System (IHS4) [Time frame: 2.5 - 3 years]
Long-term efficacy of sonelokimab: Number of abscesses, draining fistulas/tunnels; inflammatory nodules [Time frame: 2.5 - 3 years]
Long-term efficacy of sonelokimab: Dermatology Life Quality Index (DLQI) [Time frame: 2.5 - 3 years]
Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Quality of Life (HiSQOL) [Time frame: 2.5 - 3 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment