Deucravacitinib in PG (NCT05821374) | Clinical Trial Compass
WithdrawnEarly Phase 1
Deucravacitinib in PG
Stopped: Issues with funding and IND holder
United States0Started 2024-04-29
Plain-language summary
The main goal of this study is to see if the study drug called "Deucravacitinib" is safe and effective in treating people with pyoderma gangrenosum (PG).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Men and women between the ages of 18-70 years old
* Diagnosed with pyoderma gangrenosum requiring one major and at least 4 minor criteria
* Women must not be pregnant, lactating, or planning pregnancy during the study period
* Women of child-bearing potential must be on birth control for the duration of the treatment period.
* Subjects must agree to the use of at least one of the following contraception methods for the entire duration of the study until at least 30 days after taking their last dose of study drug:
* Women: Hormonal contraception (oral, injections, patch, implant, or vaginal-ring); Spiral (with or without hormones); any sterilization methods; a partner who has had a vasectomy; or sexual abstinence.
* Other acceptable methods of contraception are male or female condoms (with or without spermicide) or a cap, diaphragm, or sponge with spermicide.
* Willing to discontinue topical and/or systemic therapies, with the exception of oral rescue therapy with steroids.
* The wash period for systemic therapies will largely depend on the specific treatment but, in general, will be at least 6 months for biologics and 3 months for other immune- suppressants such as cyclosporine, mycophenolate mofetil, methotrexate, etc. No wash out period is required for topicals.
* Capable and willing to sign Institutional Review Board/IEC-approved written informed consent form in accordance with regulatory and institutional guidelines before the performance of any pro…
What they're measuring
1
Change in Physician's Global Assessment (PGA)
Timeframe: Baseline; Days 8, 15, 29, 57, and 85; Follow up Day 115
2
Change from baseline in ulcer size measured by calculating the area of the ulcers in centimeters squared using a digital application.
Timeframe: Baseline; Days 8, 15, 29, 57, and 85; Follow up Day 115