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Completed

NCT Number: NCT05322473

Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa

This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Site, Sofia, 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

  • Participant is ≥18 years of age;
  • Participant has been diagnosed with hidradenitis suppurativa as determined by the investigator and has a history of signs and symptoms of hidradenitis suppurativa dating back at least 6 months prior to the Screening Visit;
  • Participant has a total abscess and/or inflammatory nodule (AN) count of ≥5;
  • Participant has hidradenitis suppurativa lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (i.e., be Hurley Stage II or III);
  • Participant 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;
  • Participant must be, in the opinion of the investigator, at both the Screening Visit and study treatment initiation, a suitable candidate for treatment with adalimumab per approved local product information.

Exclusion criteria

  • Participants with known hypersensitivity to sonelokimab or any of its excipients;
  • Participants with known hypersensitivity to adalimumab or any of its excipients;
  • Participant has a draining fistula count of ≥20 at the Screening Visit;
  • Participant has any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of hidradenitis suppurativa;
  • Prior exposure to more than 2 biologic response modifiers;
  • Participant has a diagnosis of ulcerative colitis or Crohn's disease.

Treatment and study plan

Sonelokimab (M1095)

Drug

randomized treatment; parallel-group

Adalimumab

Drug

randomized treatment; parallel-group

Placebo

Other

randomized treatment; parallel-group

Primary outcomes

  1. Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 12

    Time frame: At Week 12

    HiSCR75 was 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. A non-responder imputation (NRI) method was used for missing data.

Secondary outcomes

  1. Percentage of Participants Achieving HiSCR50 at Week 12

    Time frame: At Week 12

    HiSCR50 was defined as at least a 50% reduction from baseline in abscess and AN count, with no increase from baseline in abscess or draining fistula count. An NRI method was used for missing data.

  2. Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 12

    Time frame: Baseline and Week 12

    The IHS4 is a validated tool to dynamically assess hidradenitis suppurativa (HS) severity. The IHS4 score was calculated as: number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of ≤3 signified mild, score of 4 to 10 signified moderate, and score of ≥11 signified severe disease. A negative change from baseline indicated an improvement in HS severity.

  3. Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of ≤5 at Week 12

    Time frame: At Week 12

    The DLQI is an instrument designed to assess the impact of the disease on a participant's dermatology-specific quality of life (QoL). The DLQI total score ranged from 0 to 30, with higher scores indicating greater health-related QoL impairment. A negative change from baseline indicated an improvement in health-related QoL. An NRI method was used for missing data.

  4. Percentage of Participants Achieving a Numerical Rating Scale (NRS) 30 in Patient's Global Assessment (PGA) of Skin Pain at Week 12, in Participants With Baseline NRS ≥3

    Time frame: At Week 12

    The PGA of Skin Pain NRS in the past 24 hours was used to assess pain "at its worst" due to HS in the last 24 hours and was completed by the participant using the electronic Diary device. NRS scores ranged from 0 to 10, with higher scores indicating greater skin pain. The weekly averages score was calculated based on the available daily scores from the 7 days on or prior to the nominal day of the visit. The average of the 7 days on or before the date of first dose of trial treatment was used as baseline. A PGA skin pain responder was a participant who achieved NRS30, defined as at least 30% reduction and at least 1-unit reduction from baseline in NRS in PGA skin pain. An NRI method was used for missing data.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

MoonLake Immunotherapeutics AG

Industry

Registry information

Official study title

Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Moderate to Severe Hidradenitis Suppurativa

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2022
Registry last updated
Sep 9, 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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