VIS954 for Treating Inflammatory Skin Problems

Sponsor ID
381-201-00028
Clinicaltrials.gov ID
NCT07933445
EudraCT ID
N/A
EUCTIS ID
2026-525969-41-00
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
844-687-8522 or [email protected]
Will Be Recruiting
Sponsor ID
381-201-00028
Trial Details
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Age
18 - 85 Years
Therapeutic Area
  • Unmapped
    • Sex
    Female & Male
    Trial Dates
    Nov 2026 - Mar 2029
    Healthy Volunteers
    No
    • Key Inclusion Criteria
    • Participant must be at least 18 years of age or have reached the legal age of consent in their country, whichever is higher.
    • HS- Adults with moderate-to-severe HS of at least 6 months' duration, classified as Hurley Stage II or III, with an inadequate response, intolerance, or contraindication to prior standard systemic antibiotic therapy.
    • PG-Adults with clinically confirmed moderate-to-severe ulcerative PG requiring systemic therapy and presenting with at least one active ulcerative lesion of less than 6 months' duration.
    • BP-Adults with newly diagnosed or relapsing classical BP, confirmed by clinical presentation and direct immunofluorescence and/or BP180/BP230 serology, with moderate disease activity.
    • Key Exclusion Criteria
    • Participants cannot join the study if they have another active skin condition, medical condition, or mental health condition that, in the study doctor's opinion, could affect the study results, increase safety risks, require restricted medications during the study, or make participation unsuitable.
    • HS-Lack of adequate response, as determined by the investigator.
    • PG-Presence of active infection involving the target ulcer or non-PG mimics that may interfere with assessment of pyoderma gangrenosum disease activity or treatment response.
    • BP- Participants with any pemphigoid disease other than classic BP, BP secondary to medications, or any severe comorbid illness.

    Study Summary

    This is a phase 2, multicenter, basket study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of VIS954 in adults with inflammatory skin diseases (ISDs).

    Additional Study Details

    Phase
    Phase 2
    Study Drug
    Drug: VIS954
    Type
    Interventional
    Masking
    Double
    Estimated Enrollment
    108
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Key Inclusion Criteria
    • 1. Participant must be at least 18 years of age or have reached the legal age of consent in their country, whichever is higher.

    Exclusion Criteria

    Inclusion and Exclusion Criteria
    • Key Inclusion Criteria
    • Participant must be at least 18 years of age or have reached the legal age of consent in their country, whichever is higher.
    • HS- Adults with moderate-to-severe HS of at least 6 months' duration, classified as Hurley Stage II or III, with an inadequate response, intolerance, or contraindication to prior standard systemic antibiotic therapy.
    • PG-Adults with clinically confirmed moderate-to-severe ulcerative PG requiring systemic therapy and presenting with at least one active ulcerative lesion of less than 6 months' duration.
    • BP-Adults with newly diagnosed or relapsing classical BP, confirmed by clinical presentation and direct immunofluorescence and/or BP180/BP230 serology, with moderate disease activity.
    • Key Exclusion Criteria
    • Participants cannot join the study if they have another active skin condition, medical condition, or mental health condition that, in the study doctor's opinion, could affect the study results, increase safety risks, require restricted medications during the study, or make participation unsuitable.
    • HS-Lack of adequate response, as determined by the investigator.
    • PG-Presence of active infection involving the target ulcer or non-PG mimics that may interfere with assessment of pyoderma gangrenosum disease activity or treatment response.
    • BP- Participants with any pemphigoid disease other than classic BP, BP secondary to medications, or any severe comorbid illness.

    Locations

    No locations found.

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