Germany-based Boehringer Ingelheim has begun enrolling patients in a global Phase III trial (Senscis) of nintedanib, a potential treatment for systemic sclerosis (SSc).
The trial will test the safety and efficacy of nintedanib in SSc patients who have developed interstitial lung disease (SSc-ILD).
It is expected to enrol a total of 520 people in clinical trial centres worldwide.
SSc is a rare disease characterised by the thickening and scarring of connective tissue of multiple organs in the body.
Cleveland Clinic Foundation physician Kristin Highland said: "People affected by SSc-ILD are often young, between 25 and 55 years old, and are faced with considerable disability related to the systemic nature of scleroderma.
"They often have significant shortness of breath and cough from lung disease and severe pain and contractures as a consequence of their skin involvement. This occurs during years when they are deeply engaged in building careers and caring for family.
"There are no approved treatments for SSc-ILD, and few drugs have been assessed in clinical trials for this disease. The Senscis trial will help to further inform the medical community about SSc-ILD and whether nintedanib could be an effective therapy for people with this condition."
The Phase III trial will evaluate twice-a-day 150mg doses of nintedanib over 52 weeks in SSc sufferers, and up to a maximum of 100 weeks in patients with SSc-ILD.
The trial’s primary endpoint is the annual rate of decline in forced vital capacity (FVC), a measure of disease progression, while key secondary endpoints include an absolute change from baseline in the modified Rodnan Skin Score (mRSS).
Boehringer Respiratory Medicine therapeutic area head Dr William Mezzanotte said: "Nintedanib, which is marketed as OFEV, is approved for a rare lung disease called idiopathic pulmonary fibrosis, or IPF, and has been shown to slow disease progression as measured by annual rate of decline in lung function.
"Because SSc-ILD and IPF share similarities in how the underlying lung scarring, or fibrosis, forms in people with the disease, we are evaluating whether nintedanib can have a beneficial impact on lung fibrosis associated with SSc.
"The Senscis study is another milestone in our ongoing commitment to furthering science that addresses the unmet needs of people affected by rare diseases and serious respiratory conditions, including fibrotic lung diseases."
OFEV / Nintedanib is a small molecule tyrosine kinase inhibitor developed by Boehringer for IPF.