CONQUEST platform trial of SSc-ILD now enrolling patients in US

Study currently includes therapies developed by Sanofi, Boehringer Ingelheim

Andrea Lobo, PhD avatar

by Andrea Lobo, PhD |

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CONQUEST, a platform clinical trial launched by the Scleroderma Research Foundation (SRF), is now enrolling people with interstitial lung disease associated with systemic scleroderma (SSc-ILD) at centers in the U.S.

The study is analyzing two investigational therapies using a master protocol to compare both treatments with a shared placebo group. It currently includes investigational therapies developed by Sanofi and Boehringer Ingelheim for SSc-ILD, but new medications may be added or removed.

The main goal of trials like CONQUEST is to identify treatments that are worthy of advancing from early clinical testing to the next phase of development, in this case from Phase 2b to larger Phase 3 trials, thereby contributing to developing new therapies.

“By establishing a network of high-performing centers, and with the vital participation of people living with this disease, we can accelerate efforts to advance novel therapies for treating scleroderma,” Gregory Gordon, MD, SRF’s chief medical officer, said in a foundation press release.“We look forward to how CONQUEST will benefit the scleroderma community by enabling the successful development of new drugs.”

SSc is a type of scleroderma wherein scar tissue accumulates in the skin and internal organs such as the lungs, heart, kidneys, and gastrointestinal tract. SSc-ILD occurs when scar tissue builds up in the lungs, impairing their ability to take in and transfer oxygen to the bloodstream. This can cause patients to have shortness of breath and fatigue.

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Enrolling in CONQUEST

About 430 patients are expected to enroll in CONQUEST through the first round. Its participants will be randomly assigned to one of the two treatments, or a placebo, for 52 weeks, or about a year. Since a single placebo is used as a common control, fewer patients will receive it, meaning about two-thirds will be given an active therapy.

Eligible patients must be 18 years and older, have an SSc-ILD diagnosis and SSc symptoms, excluding Raynaud’s disease, starting within the last five years. Patients with early Raynaud’s disease, one of the earliest symptoms of scleroderma in which the fingers and toes feel numb and change color in response to cold temperatures or stress, are allowed to enter the trial.

The participants may be further divided by SSc subtype or if they previously used mycophenolate mofetil, an immunosuppressant.

The first patient was enrolled in April and the trial is quickly expanding to sites across the U.S. It’s planned for more than 30 countries, with the predicted geographic distribution being about a third in the U.S., a third in Europe, and the remainder elsewhere in the world.

The trial’s primary goal is to assess the effects of experimental therapies in forced vital capacity, a lung function parameter that measures the maximum amount of air a person can forcibly exhale after a deep breath, over 52 weeks. The long-term goal of CONQUEST is to bring in new therapies to test to establish a continuous flow of potentially new therapies for SSc.

“This groundbreaking effort is a testament to our unwavering commitment to ultimately find a cure for this disease and it would not be possible without the dedicated patients who join us as clinical trial participants,” Gordon said.