A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris
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|ClinicalTrials.gov Identifier: NCT03780166|
Recruitment Status : Not yet recruiting
First Posted : December 19, 2018
Last Update Posted : December 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pemphigus Vulgaris||Drug: INCB050465||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris|
|Estimated Study Start Date :||February 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||October 2020|
INCB050465 administered orally once daily at the cohort-specified dose level.
- 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 INCB050465 [ Time Frame: Up to 6 weeks ]Maximum observed concentration.
- tmax of INCB050465 [ Time Frame: Up to 6 weeks ]Time to maximum concentration.
- Cmin of INCB050465 [ Time Frame: Up to 6 weeks ]Minimum observed concentration over the dose interval.
- AUC0-t of INCB050465 [ 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 INCB050465 [ 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
|Contact: Incyte Corporation Call Center (US)||firstname.lastname@example.org|
|Contact: Incyte Corporation Call Center (ex-US)||+800 email@example.com|
|Study Director:||Kathleen Butler, MD||Incyte Corporation|