Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT04274166
Eligibility Criteria:
Inclusion Criteria:
1\. Must give written informed consent. 2. Has a diagnosis of pyoderma gangrenosum, as determined by the investigator based on the following diagnostic criteria4:
a. Diagnosis requires both major criteria and at least two minor criteria i. Major criteria
1. Rapid progression of a painful, necrolytic cutaneous ulcer with an irregular, violaceous, and undermined border
2. Other causes of cutaneous ulceration have been excluded ii. Minor criteria
1\. History suggestive of pathergy or clinical finding of cribriform scarring 2. Systemic diseases associated with PG 3. Histopathologic findings (sterile dermal neutrophilia, ± mixed inflammation, ± lymphocytic vasculitis) 4. Treatment response (rapid response to systemic steroid treatment)
3\. PG global assessment of moderate to severe, with at least one ulcer measuring at least 3 cm in diameter.
4\. 18 years of age or greater. 5. Must require systemic therapy for their pyoderma gangrenosum, as determined by the investigator prior to Baseline. Currently prescribed low-dose corticosteroids (≤ 10 mg/day), and other medications within one week prior to investigational drug administration, may be continued with no change in dose or frequency during the study.
Exclusion Criteria:
1. Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
2. Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed).
3. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
4. Treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
5. Treatment with high dose (\>10 mg/day) systemic steroids (prednisone) within one week prior to investigational drug administration. Treatment with cyclosporine, thalidomide, methotrexate, mycophenolate mofetil, azathioprine, or other systemic immunosuppressant agents within the 14 days prior to investigational drug administration (requirement of a 2-week washout).
6. Known HIV+, known viral hepatitis infection, known tuberculosis infection.
7. Any subject with a current or history of a malignancy in the last five years (excluding treated basal cell carcinoma).
8. Clinically significant abnormal laboratory measures at screening.
9. Known Irritable Bowel Disease-associated PG
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04274166
Study Brief:
Protocol Section:
NCT04274166