Boehringer joins CONQUEST platform trial of SSc-ILD treatments
Effort led by Scleroderma Research Foundation aims to open next year in US
Boehringer Ingelheim has joined the CONQUEST platform trial, adding a second experimental medication to the multidrug study launched by the Scleroderma Research Foundation (SRF) to speed therapy development for interstitial lung disease (ILD) associated with scleroderma (SSc).
In a platform trial, a master protocol is used to compare multiple treatment candidates against a shared control group. New medications can be added or discontinued over time, reducing trial costs and the time to complete clinical testing.
These randomized clinical studies aim to identify candidates worthy of advancing from early testing to the next trial level — in this case, from a Phase 2b study to larger Phase 3 trials.
CONQUEST will be first platform trial of potential SSc-ILD treatments
“The addition of a second deeply committed and highly sophisticated partner to CONQUEST is a strong validation of the platform’s promise and value,” Luke Evnin, PhD, who chairs the SRF, said in a foundation press release.
“With two partners, CONQUEST is fully subscribed and fully funded, ensuring … the vision of building a global community tuned to rapid and efficient clinical development of promising novel therapeutic agents for the high unmet needs of our scleroderma patients,” Evnin added.
Scleroderma, also called systemic sclerosis, causes the skin and possibly internal organs and blood vessels to thicken and scar. When this happens in the lungs, it raises a risk of interstitial lung disease, which can make it difficult to breathe and get oxygen into the bloodstream.
“We are deeply committed to innovation in pulmonary fibrosis [lung scarring] across a range of indications,” said Ioannis Sapountzis, PhD, global head of therapeutic areas at Boehringer. The company markets Ofev (nintedanib), approved to slow lung function decline in SSc-ILD.
“We have chosen to partner with the SRF in scleroderma because we believe the benefits of highly innovative CONQUEST platform for all of the CONQUEST stakeholders — patients, clinical trial sites, and innovators — are dramatic and important,” Sapountzis added.
Scleroderma foundation planning to open trial in US in 2024
Initiation of the platform trial is targeted for the U.S. in early 2024, with other countries opening later that year, SRF reports. A goal is to complete enrollment of patients from over 130 centers in more than 22 countries by mid-2025.
According to its master protocol, people with an SSc-ILD diagnosis will be randomly divided into two groups and then assigned to receive a treatment candidate or a shared placebo for 52 weeks, about one year.
Participants may be further divided based on factors such as previous use of mycophenolate mofetil, an immunosuppressant, or by SSc subtype (limited or diffuse).
Its primary outcome measure is changes in forced vital capacity, a measure of the maximum amount of air that can be forcibly exhaled after a deep breath, from trial entry to week 52.