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NCT Number: NCT06411899

A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.

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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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical SIte, Pleven, Bulgaria

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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 must be at least 18 years of age at the time of signing the informed consent.
  • Participants who are diagnosed with hidradenitis suppurativa as determined by the investigator and have a history of signs and symptoms of hidradenitis suppurativa for at least 6 months before signing the informed consent.
  • Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of hidradenitis suppurativa (or demonstrated intolerance to, or had a contraindication to, systemic antibiotics for treatment of their HS), in the investigator's opinion.
  • Participants who have a total AN count of ≥5.
  • Participants who have HS lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (ie, be Hurley Stage II or III).

Exclusion criteria

  • Participants with a known hypersensitivity to sonelokimab or any of its excipients.
  • Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
  • Participants with underlying conditions that, in the opinion of the investigator, potentially places the participant at unacceptable risk.
  • Participants with current severe or uncontrolled disease(s) that put(s) the participant at increased risk in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
  • Participants with any other known autoimmune disease or any medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS.
  • Participants with a gastrointestinal condition including inflammatory bowel disease or diagnosis of ulcerative colitis or Crohn's disease.

Treatment and study plan

Sonelokimab

Drug

Sonelokimab

Placebo

Drug

Placebo

Primary outcomes

  1. Hidradenitis Suppurativa Clinical Response 75

    Time frame: Week 16

    Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) where HiSCR75 is defined as at least a 75% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count.

Secondary outcomes

  1. Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)

    Time frame: Week 16

    Percentage of participants achieving HiSCR50

  2. Change in International Hidradenitis Suppurativa Severity Score System

    Time frame: Week 16

    Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)

    The IHS4 score is calculated as follows: number of nodules (multiplied by 1) + number of abscesses (multiplied by 2) + number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.

  3. Dermatology Life Quality Index (DLQI)

    Time frame: Week 16

    Percentage of participants achieving a DLQI total reduction of ≥4 minimal clinically important difference among participants with a baseline DLQI ≥4. DLQI produces a numeric score that can range from 0 to 30. A higher score indicates greater health related quality of life impairment.

  4. Reduction from Numerical Rating Scale (NRS30 & NR550) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)

    Time frame: Week 16

    Percentage of participants achieving at least ≥30% (and ≥50%) reduction and at least 2-unit reduction from Baseline in Numerical Rating Scale (NRS30 & NRS50) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3

  5. Patient Global Impression-Severity of Illness-Hidradenitis Suppurativa at Week 16

    Time frame: Week 16

    Percentage of participants with minimal or absent symptoms using the Patient Global Impression - Severity of Illness - Hidradenitis Suppurativa at Week 16. Participants choose the response that best describes the severity of their disease. The question is rated on a 7-point scale ranging from 0 to 6 (0=absent; 1=minimal; 2=mild; 3=moderate; 4=moderately severe; 5=severe; 6=very severe).

  6. Resolution of draining tunnels (DT100)

    Time frame: Week 16 and Week 52

    Percentage of participants with zero draining tunnels in the subgroup of participants with at least one draining tunnel at baseline (DT100)

Sponsors and collaborators

Lead sponsor

MoonLake Immunotherapeutics AG

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 13, 2024
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.

View the official ClinicalTrials.gov record (opens in a new tab)

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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