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:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT02733094
Eligibility Criteria:
* Key Inclusion Criteria:
* Confirmed diagnosis of Pyoderma gangrenosum
* Biopsy-proven, non-healing ulcer with primarily neutrophil infiltration, regardless of size and location
* Characterization of target lesion (size, PGA, duration)
* 18-75 years of age
* Body weight ≥ 40 kg and ≤ 160 kg
* Signed informed consent
* Key Exclusion Criteria:
* Permanent severe diseases, especially those affecting the immune system
* Pregnancy or breast feeding
* History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
* Myocardial infarction or cardiac arrhythmia which requires drug therapy
* Evidence of severe renal dysfunction or significant hepatic disease
* History of irritable bowel disease
* History of lymphoproliferative disorders
* Evidence for active infection including but not limited to active tuberculosis, HIV or hepatitis B/C that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
* History of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02733094
Study Brief:
Protocol Section:
NCT02733094