A Study of the Safety and Tolerability of Parsaclisib in Pemphigus Vulgaris
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|ClinicalTrials.gov Identifier: NCT03780166|
Recruitment Status : Withdrawn (The study was withdrawn due to insufficient interest in study participation due to recent approval in this rare condition.)
First Posted : December 19, 2018
Last Update Posted : April 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pemphigus Vulgaris||Drug: Parsaclisib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Dose-Escalation Study of the Safety and Tolerability of Parsaclisib in Participants With Pemphigus Vulgaris|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Parsaclisib administered orally once daily at the cohort-specified dose level.
Other Name: INCB050465
- Number of treatment-emergent adverse events [ Time Frame: Up to 20 weeks ]Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
- Cmax of Parsaclisib [ Time Frame: Up to 6 weeks ]Maximum observed concentration.
- tmax of Parsaclisib [ Time Frame: Up to 6 weeks ]Time to maximum concentration.
- Cmin of Parsaclisib [ Time Frame: Up to 6 weeks ]Minimum observed concentration over the dose interval.
- AUC0-t of Parsaclisib [ Time Frame: Up to 6 weeks ]Area under the concentration-time curve from time = 0 to the last measurable concentration at time = t.
- CL/F of Parsaclisib [ Time Frame: Up to 6 weeks ]Apparent oral dose clearance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780166
|Study Director:||Kathleen Butler, MD||Incyte Corporation|