Celiac disease is an immune-mediated condition triggered by gluten consumption in genetically susceptible individuals, leading to inflammation of the small intestine. While a gluten-free diet is the standard approach for achieving remission, it poses lifelong social and economic challenges. With no approved pharmacological treatments currently available, ongoing research is exploring innovative therapeutic options to improve health outcomes for those with CeD.
Since a fully validated histologic index for CeD activity is unavailable, regulatory agencies recommend employing a histologically clinically accepted scale alongside signs and symptoms as co-primary endpoints in clinical trials assessing CeD improvement or resolution.
A major hurdle in CeD drug development is the lack of validated and objective measures to assess disease activity and therapeutic efficacy. Since a fully validated histologic index is unavailable, regulatory agencies recommend using clinically acceptable histologic scales alongside clinical signs and symptoms as co-primary endpoints in trials.
Alimentiv Is addressing these challenges and developed a comprehensive framework for future trials in collaboration with renowned experts. Our commitment and work are focused on research priorities that accelerate CeD drug development with the support of expert panel’s guidance:
Background & aims: There is a need to develop safe and effective pharmacologic options for the treatment of celiac disease (CeD); however, consensus on the appropriate design and configuration of randomized controlled trials (RCTs) in this population is lacking.
Objective: Although several pharmacological agents have emerged as potential adjunctive therapies to a gluten-free diet for coeliac disease, there is currently no widely accepted measure of disease activity used in clinical trials.
Our commitment extends to identifying future research priorities, including studies comparing the performance characteristics of endoscopic, histologic, and patient-reported outcome (PRO) instruments, which are crucial for defining the most suitable tools in randomized controlled trials (RCTs).
Alimentiv brings the same evidence-based passion that has positioned us as leaders in clinical trial design and implementation in inflammatory bowel disease (IBD) to CeD drug discovery. With our proven track record in developing and validating outcome measures in inflammatory bowel disease (IBD), we are accelerating drug development for patients with CeD through dedicated research, including:
Standardized histopathologic scoring conventions.
Improved reliability of histopathologic assessments.
Evidence-based recommendations for clinical trial outcome measures.
At Alimentiv, we are committed to advancing CeD drug development through scientific & medical innovation, expert collaboration, and operational excellence.
Gastroenterology Expertise & Thought Leader Engagement: Leveraging strong industry relationships to refine trial design and protocol development using a Quality by Design approach.
Extensive GI Site Network: Access to 5,000+ GI sites in more than 60+ countries, enhancing recruitment efficiency and reducing trial timelines.
Efficient Study Start-Up Processes: A dedicated team with proven success in rapid site activation.
Expert Central Histopathology Readers: Specialized readers ensuring accurate and consistent histopathologic assessments.
Translational Medicine & Scientific Collaborations: Integrating advanced biomarker research techniques, such as immunohistochemistry, to enhance trial outcomes.
Biostatistical Excellence: Ensuring robust trial methodologies and clinically meaningful results.
At Alimentiv, our team is committed to advancing CeD drug development through scientific innovation, expert collaboration, and operational excellence.
Join us at DDW to explore Alimentiv’s groundbreaking research.
When: May 3–6, 2025 in San Diego, CABooth #4549
