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

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

Status

Enrolling by invitation

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07007637

Enrollment

835

Registered

2025-06-06

Start date

2025-06-27

Completion date

2028-06-13

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa, Hidradenitis, Sweat Gland Diseases, Skin Diseases, Skin Diseases, Bacterial, Suppuration, Anti-Inflammatory Agents, Sonelokimab, Nanobody, Apocrine Gland Disease

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.

Interventions

DRUGSonelokimab

Sonelokimab

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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 (AEs) following treatment with sonelokimab	2.5-3 years	Incidence, relatedness, severity and seriousness of all AEs
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

Measure	Time frame	Description
Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)	2.5 - 3 years	Percentage of participants achieving a HiSCR75 response over time
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

Countries

Belgium, Bulgaria, Canada, France, Germany, Hungary, Italy, Norway, Poland, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026