Celiac disease (CeD) manifests as inflammation in the small intestine and is triggered by gluten consumption in genetically susceptible individuals. Achieving remission typically involves adhering to a gluten-free diet, but the lifelong commitment can pose social and economic challenges. Although no approved treatments exist for CeD, ongoing investigations explore new pharmacological strategies to enhance health and quality of life for those with CeD.
A significant obstacle to drug development in this field is the absence of valid and reliable objective measures to assess disease activity and the efficacy of potential therapies for 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. Alimentiv has developed a comprehensive framework for future trials in collaboration with renowned experts, emphasizing research priorities to expedite CeD drug development. Our expert panel’s guidance encompasses clinical trial design recommendations, eligibility criteria, outcome measures, gluten challenge, and disease evaluation. 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). We aim to accelerate drug development for individuals with CeD through dedicated research.
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. Our experience in IBD underscores the importance of robust and fully validated indices with clear definitions, ensuring reproducibility and agreement among expert central readers for successful implementation in clinical trials.
Systematically review the operating properties of Celiac outcome measures
Standardize histopathologic scoring conventions
Improve the reliability of histopathologic assessment
Recommend appropriate outcome measures for clinical trials
In-depth gastroenterology expertise and strong relationships with thought leaders, which position us well to support you with further development on trial design and protocol development leading to a Quality by Design approach.
Our network of over 5,000 GI sites provides you with access to a large pool of high-potential sites driving an efficient recruitment strategy and shortening recruitment timelines.
An established relationship with the Celiac Disease Foundation which enables our use of their services and therapeutic expertise for any Celiac Disease study.
Our study start-up team has extensive experience with rapid site activation and applies effective processes to ensure studies launch as efficiently as possible.
Highly trained central histopathology readers whose disease-specific expertise helps to reduce histopathologic outcome variability.
Scientific collaborators and strategic scientific partnerships that facilitate the design and incorporation of translational medicine research (e.g. immunohistochemistry) into clinical trials.
Biostatisticians whose expertise in clinical trials ensures high-quality and clinically relevant results.
