Clinical trial NCT07007637: A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Suppuration
Anti-Inflammatory Agents
Sonelokimab
Nanobody
Apocrine Gland Disease
Lead sponsor: MoonLake Immunotherapeutics AG
Sponsor class: INDUSTRY
First posted: 2025-06-06
Enrollment: 835
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab
timeFrame: 2.5-3 years
measure: Long-term safety and tolerability of sonelokimab: Treatment emergent adverse events (TEAEs)
timeFrame: 2.5-3 years
measure: Long-term safety and tolerability of sonelokimab: Adverse events of special interest (AESIs)
timeFrame: 2.5-3 years
measure: Long-term safety and tolerability of sonelokimab: Discontinuation of sonelokimab treatment due to AEs
timeFrame: 2.5-3 years
measure: Long-term safety and tolerability of sonelokimab: Clinically significant changes in clinical laboratory parameters
timeFrame: 2.5-3 years
measure: Long-term safety and tolerability of sonelokimab: Clinically significant changes in vital signs and standard 12-lead electrocardiogram
timeFrame: 2.5-3 years
Secondary outcomes:
measure: Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
timeFrame: 2.5 - 3 years
measure: Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) and 50 (HiSCR50)
timeFrame: 2.5 - 3 years
measure: Long-term efficacy of sonelokimab: International Hidradenitis Suppurativa Severity Score System (IHS4)
timeFrame: 2.5 - 3 years
measure: Long-term efficacy of sonelokimab: Number of abscesses, draining fistulas/tunnels; inflammatory nodules
timeFrame: 2.5 - 3 years
measure: Long-term efficacy of sonelokimab: Dermatology Life Quality Index (DLQI)
timeFrame: 2.5 - 3 years
measure: Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Quality of Life (HiSQOL)
timeFrame: 2.5 - 3 years
Other outcomes:
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