rVA576 in Adult Mild to Moderate Bullous Pemphigoid Subjects
|ClinicalTrials.gov Identifier: NCT04035733|
Recruitment Status : Completed
First Posted : July 29, 2019
Last Update Posted : November 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bullous Pemphigoid (BP)||Biological: rVA576||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A Phase IIa open-label single arm study of safety and efficacy of rVA576 in adult mild to moderate Bullous Pemphigoid subjects|
|Masking:||None (Open Label)|
|Official Title:||A Phase IIa Open-label Single Arm Study of Safety and Efficacy of rVA576 in Adult Mild to Moderate Bullous Pemphigoid Subjects|
|Actual Study Start Date :||September 25, 2018|
|Actual Primary Completion Date :||March 12, 2020|
|Actual Study Completion Date :||April 29, 2020|
|Experimental: Open-label single arm study||
BP subjects will be treated with 30 mg once daily rVA576 regime for 6 weeks.
- Safety parameter [ Time Frame: 42 days ]
Proportion of participants reporting grade 3, 4 and 5 adverse events, which are related/possibly related to rVA576 during the treatment period.
Treatment emergent adverse events (TEAEs) consist of:
- Change from baseline in physical examination
- Clinical laboratory tests
- Vital signs The Common Terminology Criteria for Adverse Events (CTCAE v4.03) will be used to grade adverse events.
- Efficacy Parameter [ Time Frame: 42 days ]Change in BPDAI between baseline (Day 1) and Day 42.
- Quality of life questionnaire [ Time Frame: 42 days ]Change in quality of life questionnaire between baseline (Day 1) and Day 42
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035733
|University of Lubeck|
|Groningen, Hanzeplein 1, Netherlands, 9700 RB|