Spesolimab in Pyoderma Gangrenosum (NCT06092216) | Clinical Trial Compass
TerminatedPhase 2
Spesolimab in Pyoderma Gangrenosum
Stopped: The funding sponsor terminated our study and will conduct a multicenter national study in its place.
United States5 participantsStarted 2023-09-23
Plain-language summary
The purpose of this research study is to assess the feasibility of using spesolimab in participants with moderate to severe pyoderma gangrenosum. Pyoderma gangrenosum is a rare, inflammatory, autoimmune condition which results in ulceration of skin. The study will also investigate the body's immune response to the spesolimab (when the body detects and defends itself against substances that appear unknown and harmful).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female subjects ≥ 18 years of age at the time of signing the informed consent document
* Subject is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures
* Subject is able to adhere to the study visit schedule and other protocol requirements.
* Subject has clinically diagnosed ulcerative PG with PARACELSUS score greater than or equal to 10
* Subject has at least one clinically measurable ulcerative PG lesion on body that has failed to respond to at least one prior therapy such as (but not limited to) topical corticosteroids, intralesional triamcinolone, prednisone, cyclosporine, IL-23 inhibitor, IL-17 inhibitors, IL-1 inhibitors, or TNF-α- blocker therapy
* Subject has moderate to severe PG as determined by a GPG severity score of ≥3
* Subject is judged to be in otherwise good overall health as judged by the investigator, based on medical history, limited physical examination, and laboratory testing. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
* Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
* Option 1: A…
What they're measuring
1
Change in Global Pyoderma Gangrenosum (GPG) Severity Score