CVAY736X2207 efficacy, safety, and tolerability of VAY736
Research type
Research Study
Full title
A subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis
IRAS ID
239530
Contact name
Nikhil Hirani
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2017-002667-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 30 days
Research summary
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, lung disease that causes scarring of the lung tissue, making it harder to breathe. It is associated with an average survival of 2-5 years from initial diagnosis. IPF affects approximately 1.5 million patients worldwide. Recently, nintedanib and pirfenidone were shown to slow the rate of IPF progression by targeting the biology of fibroblasts (wound healing cells). However, it was shown that nintedanib and pirfenidone cannot halt the progression of IPF disease. Furthermore, neither nintedanib nor pirfenidone was able to demonstrate a significant impact on IPF death. Therefore, a considerable unmet medical need remains.
The drug being studied in this study, VAY736, may improve lung function in patients with IPF using a remodelling process.
In IPF, B cell abnormalities are common and plasma (part of the blood component) concentrations of B cell activating factor (BAFF) are elevated, showing a potential link between IPF, abnormal B cells, and autoimmune inflammation (attack of healthy cells that cause infection). B cell markers, such as CXCL13, are also significantly increased in IPF. Together, these findings support the idea of specifically targeting B cells to inhibit scarring in patients with IPF.The main purpose of this study is to investigate the safety (side effects), tolerability (how well the drug is tolerated in the body) and efficacy (how well the study drug works) of 300mg VAY736 subcutaneously every 4 weeks for 48 weeks as potential therapy for the treatment of idiopathic pulmonary fibrosis (IPF).
Participants will be required to undergo a series of study assessments during the visits including the collection of blood samples and completion of lung function tests to see how well your lungs work. The total duration of the study for each participant will be approximately 75 weeks of treatment and follow-up assessments. The length of study participations will depend upon which treatment the participant has been assigned to receive (VAY736 or placebo) and their individual response to the study treatment.
The study is sponsored by Novartis. Around 84 research participants at approximately 40 sites, in countries throughout Europe and North America will take part in this study.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0077
Date of REC Opinion
18 May 2018
REC opinion
Further Information Favourable Opinion