The Willow Study
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study.
IRAS ID
233267
Contact name
Anthony De Soyza
Contact email
Sponsor organisation
Insmed Incorporated
Eudract number
2017-002533-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 4 days
Research summary
Non Cystic Fibrosis Bronchiectasis (NCFBE) is a disease characterised by irreversible enlargement of bronchi and bronchioles that may lead to obstructed breathing caused by abnormal mucus production. Bronchiectasis symptoms typically include a dry or wet cough, and breathlessness. People with this disease often get lung infections.
The characteristic of this inflammatory lung disease is the accumulation of neutrophils (a type of white blood cell) in the tissue of the lung. Neutrophils contain granules (loaded with a variety of anti-microbial agents). Azurophilic granules are believed to be the first to form during neutrophil maturation in the bone marrow, characterised by the expression of Neutrophil Serine Proteases (NSPs) (Anti-microbial enzymes). Dipeptidyl peptidase I (DPP1) is an enzyme that activates these NSPs and is the target for the study drug. INS1007 is an inhibitor of DPP1 and it is hypothesised that INS1007 will have beneficial effects via decreasing inflammation, which will in turn lead to a decrease in pulmonary exacerbation and an improvement in lung function. There is also the potential benefit of INS1007 modifying NCFBE progression by reducing the accelerated rate of lung function decline or lung tissue destruction.
Currently, there is no standard-of-care for prophylactic treatment of NCFBE. The primary goal of treatment is to treat the underlying cause, prevent disease progression, maintain or improve lung function, and improve symptoms and quality of life.
There is no therapy approved by regulatory authorities in the US or Europe for NCFBE.The Willow Study is a Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Study where participants will be given oral INS1007 Daily for 24 Weeks. About 240 participants aged 18-85 will be included in the study across multiple countries. The purpose of The Willow Study is to evaluate the effect of INS1007 compared with placebo on time to first pulmonary exacerbation over the 24-week treatment period.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0678
Date of REC Opinion
22 Mar 2018
REC opinion
Further Information Favourable Opinion