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Enrolling by Invitation

NCT Number: NCT07007637

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

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.

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Site, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sonelokimab

Drug

Sonelokimab

Primary outcomes

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

    Time frame: 2.5-3 years

    Incidence, relatedness, severity and seriousness of all AEs

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

    Time frame: 2.5-3 years

    Incidence, relatedness, severity and seriousness of all TEAEs

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

    Time frame: 2.5-3 years

    Incidence, relatedness, severity and seriousness of all AESIs

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

    Time frame: 2.5-3 years

    Number of participants discontinued from sonelokimab treatment due to AEs

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

    Time frame: 2.5-3 years

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

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

    Time frame: 2.5-3 years

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

Secondary outcomes

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

    Time frame: 2.5 - 3 years

    Percentage of participants achieving a HiSCR75 response over time

  2. Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) and 50 (HiSCR50)

    Time frame: 2.5 - 3 years

    Percentage of participants achieving a HiSCR90 and HiSCAR50 response over time

  3. Long-term efficacy of sonelokimab: International Hidradenitis Suppurativa Severity Score System (IHS4)

    Time frame: 2.5 - 3 years

    Absolute change in IHS4 score over time

  4. Long-term efficacy of sonelokimab: Number of abscesses, draining fistulas/tunnels; inflammatory nodules

    Time frame: 2.5 - 3 years

    Absolute change in number of abscesses, draining fistulas/tunnels; inflammatory nodules

  5. Long-term efficacy of sonelokimab: Dermatology Life Quality Index (DLQI)

    Time frame: 2.5 - 3 years

    Change in DLQI total score

  6. Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Quality of Life (HiSQOL)

    Time frame: 2.5 - 3 years

    Change in HiSQOL total score

Sponsors and collaborators

Lead sponsor

MoonLake Immunotherapeutics AG

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 6, 2025
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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