rVA576 in Adult Mild to Moderate Bullous Pemphigoid Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04035733|
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bullous Pemphigoid (BP)||Biological: rVA576||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated 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|
|Estimated Primary Completion Date :||March 30, 2020|
|Estimated Study Completion Date :||March 30, 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
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): NCT04035733
|Contact: Miles Nunn, MD||02080040267||Miles.Nunn@akaritx.com|
|Contact: Wynne Westonfirstname.lastname@example.org|
|University of Lubeck||Recruiting|
|Contact: Detlef Zillikens, Prof|
|Groningen, Hanzeplein 1, Netherlands, 9700 RB|
|Contact: Barbara Horvath, MD 0031 50 361 2520 email@example.com|