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

  • STATUS
    Recruiting
  • End date
    Nov 19, 2023
  • participants needed
    210
  • sponsor
    MoonLake Immunotherapeutics AG
Updated on 19 September 2022
antibiotics
abscess
adalimumab

Summary

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.

Details
Condition Hidradenitis Suppurativa
Treatment Placebo, Adalimumab, Sonelokimab (M1095)
Clinical Study IdentifierNCT05322473
SponsorMoonLake Immunotherapeutics AG
Last Modified on19 September 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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