Skip to main content
OpenTrials
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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Site, Sofia, Bulgaria

Loading trial locations.

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. Hidradenitis Suppurativa Clinical Response 75

    Time frame: Week 12

    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

    Time frame: Week 12

    Proportion of participants achieving HiSCR50

  2. Change in International Hidradenitis Suppurativa Severity Score System

    Time frame: Week 12

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

    The IHS4 score is calculated as follows: 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 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 12

    Proportion of participants achieving a Dermatology Life Quality Index (DLQI) total score of ≤5

    The 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) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)

    Time frame: Week 12

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

    The NRS is a numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine).

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
May 3, 2024

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.

Published trials that share one or more normalized conditions with this study.