Landmark International Trial Seeks to Intercept and Prevent Crohn Disease Using Biomarkers

In an ambitious initiative that could redefine the future of Crohn’s disease (CD) management, the INTERCEPT project has launched Europe’s first trial focused on the early detection and prevention of this debilitating condition.

The 5-year, multimillion Euro initiative, backed by more than €38 million (nearly $40 million US) from the Innovative Health Initiative Joint Undertaking (IHI JU), is committed to transforming the incurable chronic illness to one that can be intercepted early and potentially prevented before symptoms manifest. The announcement was made January 22 by IHI JU.1

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The focus of the INTERCEPT trial will be to verify and clinically validate a panel of investigational biomarkers and to create a blood risk score that can identify individuals at high risk for developing Crohn’s disease before symptomatic onset, specifically within 5 years after an initial evaluation, according to the IHI statement.1

Crohn’s disease is one of the most common forms of inflammatory bowel disease (IBD) and affects approximately 3.1 million people in the US and the same number in Europe (CDC). Incidence is steadily rising among children and young adults, according to the US CDC.2 Characterized by diarrhea, abdominal pain, and weight loss, CD also increases the risk of complications, including colon cancer, delayed growth in pediatric patients, and mental health conditions, notably depression.2 Individuals with the disease experience unpredictable and alternating waves of remission and flare-ups. Despite advances in therapeutic interventions, nearly half of CD patients require surgery within a decade of diagnosis, and only 10% achieve long-term remission, according to IHI.1

Biomarkers are successfully used to detect the early stages of diseases including type 1 diabetes and rheumatoid arthritis. Preclinical candidate biomarkers have been identified for CD but have yet to be validated across diverse populations, the IHI stated.

“Biomarkers are key to future research and have the potential to revolutionise the treatment landscape for IBD,” Awny Farajallah, MD, chief medical officer at Takeda Pharmaceutical Company, the industry lead for INTERCEPT, said in the statement.1

“We have been able to design this project due to our colleagues in North America laying the scientific foundation of predictive biomarkers for Crohn’s Disease," Geert D’Haens, PhD, project coordinator from Stichting Amsterdam UMC, added. "Although our field is somewhat behind type 1 diabetes and rheumatoid arthritis, we are confident that we have strong and reliable biomarkers and very safe treatments to offer.”1

INTERCEPT will recruit 10,000 healthy first-degree relatives of CD patients from 7 European countries to further validate the identified biomarkers and the risk score. Of these participants, 80 individuals at the highest risk will participate in a prevention trial using an established and highly effective medical treatment aimed at halting disease progression.

“INTERCEPT is setting its sights on a future where Crohn’s Disease is highly manageable or even avoidable,” the announcement stated.1

The ambitious goal is being pursued through the collaborative efforts of 21 IHI partners from Europe, North America, and South Korea. “In intercepting Crohn’s Disease, we face complex scientific challenges that no one organisation can address alone,” Takeda’s Farahallah elaborated. “Our collaboration will unite public and private sector expertise and resources to more efficiently advance Crohn’s research and potentially benefit IBD patients.”1

Global Impact Potential

This cross-continental partnership also highlights the global impact and broader implications of the project. “For the first time, researchers from multiple European countries, North America, and South Korea are working together to predict and prevent Crohn’s disease. Our combined success could reinforce the concept that immune-mediated diseases—affecting the gut, joints, skin, and brain—can be prevented,” Jean-Frédéric Colombel, MD, director of the Inflammatory Bowel Disease Center at Icahn School of Medicine at Mount Sinai in New York, commented.

“I am honored to lead the unique collaboration of bright scientists,” project coordinator D’Haens emphasized. “It really feels like this may lead to the most significant scientific progress in the field since the initial description of the disease by Burrill Crohn in 1932.”

The INTERCEPT project officially kicks off on February 19, 2025, with a consortium meeting in Berlin, Germany.

References:
1. Innovative Health Initiative launches INTERCEPT: a pioneering trial aimed at realizing a future without Crohn's disease. News release. Innovative Health Initiative. January 22, 2025. Accessed January 22, 2025. https://www.intercept-ihi.eu/
2. Terlizzi EP, Dahlhamer JM, Xu F, Wheaton AG, Greenlund KJ. Health care utilization among U.S. adults with inflammatory bowel disease, 2015–2016. National Health Statistics Reports; no 152. Hyattsville, MD: National Center
for Health Statistics. 2021. doi.org/10.15620/cdc:100471