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 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT03780166
Eligibility Criteria:
Inclusion Criteria:
* Clinically documented and confirmed diagnosis of pemphigus vulgaris: minimum of 6 months of pemphigus vulgaris diagnosis; positive for anti-desmoglein (DSG)1 or DSG3; Pemphigus Disease Area Index score of 8 to 45 points; active skin, scalp, or mucosal lesions.
* Disease progression after treatment with standard therapies that are known to confer clinical benefit, or intolerant to treatment; there is no limit to the number of prior treatment regimens.
* Willingness to avoid pregnancy or fathering children.
* If required, willing to receive Pneumocystis jirovecii pneumonia prophylaxis during the study period.
Exclusion Criteria:
* Pregnant or breast-feeding female.
* Participants with pemphigus vulgaris who are treatment-naive.
* Use of protocol-specified medications within defined periods before baseline.
* Evidence or history of clinically significant infection or protocol-defined medical conditions
* Laboratory values outside the protocol-defined range at screening.
* Known or suspected allergy to parsaclisib or any component of the study drug.
* Known history of clinically significant drug or alcohol abuse in the last year before baseline.
* Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03780166
Study Brief:
Protocol Section:
NCT03780166