Ofatumumab Injection in Subjects with Pemphigus Vulgaris (OPV116910)
Research type
Research Study
Full title
OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris
IRAS ID
138505
Contact name
Karen Harman
Contact email
Sponsor organisation
Glaxo Group Ltd
Eudract number
2013-001370-20
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
116301, US IND
Research summary
Pemphigus vulgaris is an autoimmune disorder that occurs when the immune system attacks and destroys healthy body tissue instead of germs and other foreign invaders. B-cells are a type of white blood cell in the immune system that play an important role in producing these autoimmune attacks. In people with pemphigus vulgaris, B-cells produce proteins called anti DSG antibodies that cause blisters and sores.
The study drug Ofatumumab works with the body’s immune system to help destroy the B-cells.
The purpose of this study being run by GlaxoSmithKline and Stiefel is to test ofatumumab in people with pemphigus vulgaris. This study is testing a new form of ofatumumab for injection under the skin (subcutaneous injection). This form is not approved for doctors to prescribe to patients.
This study will compare ofatumumab with a placebo (a liquid with no drug in it). About 68 people will get an injection of ofatumumab and about 68 people will get an injection of placebo. This will be administered under the skin every 4 weeks.
About 136 participants in about 15 countries will take part in this study.
This study consists of a screening period (2 weeks - 3 months), a dosing period (56 weeks), and a follow-up period (4 weeks). Participants will take part in this study for about 15 to 18 months.
If the participant’s lab values have not returned to baseline at the Follow-up Visit they will be asked to stay in an Individualised Follow-up Period. Alternatively, they may have the opportunity to join an extension study
This study involves procedures including: physical exam, weight, height, blood pressure, heart rate, temperature, ECG (records the electrical activity of the heart), blood and urine tests, biopsy, surveys, and skin exam. Participants will also be asked questions including full medical history, medications, how they are feeling.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
14/EM/1083
Date of REC Opinion
27 Aug 2014
REC opinion
Further Information Favourable Opinion