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Development of drugs for celiac disease: review of endpoints for Phase 2 and 3 trials

Klaus Gottlieb1, Jill Dawson2, Fez Hussain2

  • 1Immunology and Internal Medicine - Medical Strategy & Science, Quintiles, Durham, NC, USA, Corporate Communications, Quintiles, Durham, NC, USA and Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA klaus.gottlieb@quintiles.com.

Gastroenterology Report
|March 1, 2015
PubMed

Insights

Celiac disease treatments are advancing beyond the gluten-free diet, with new drugs in development. This review discusses emerging therapies and critical regulatory endpoints for clinical trials.

Area of Science:

  • Gastroenterology
  • Clinical Pharmacology
  • Regulatory Science

Background:

  • Celiac disease is a chronic autoimmune disorder triggered by gluten ingestion.
  • Currently, a strict gluten-free diet is the only established treatment.
  • Emerging therapies offer new hope for celiac disease management.

Purpose of the Study:

  • To review novel drug development for celiac disease.
  • To explore potential regulatory endpoints for clinical trials.
  • To provide guidance on trial design for regulatory approval.

Main Methods:

  • Review of ongoing Phase 2 drug trials for celiac disease.
  • Analysis of potential clinical trial endpoints: patient-reported outcomes, histology, serology, and gene expression.
  • Discussion of regulatory requirements for Phase 2 and Phase 3 trials.

Main Results:

  • Several drug candidates show promising results in Phase 2 trials.
  • Significant discussion is needed regarding standardized regulatory endpoints.
  • Regulatory requirements differ between proof-of-concept and registration trials.

Conclusions:

  • New therapeutic avenues for celiac disease are emerging.
  • Defining clear regulatory endpoints is crucial for drug approval.
  • Understanding regulatory expectations is key for successful clinical development.
Keywords:
celiac diseaseclinical trialsendpoints

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