A Double-blind, Placebo-controlled Phase IIa Study to Evaluate the Efficacy and Safety of AZD7798 in Patients with Moderate to Severe Crohns Disease [AMALTHEA] (NCT06450197)

This is a randomised, double-blind, parallel group, placebo-controlled Phase IIa study designed to evaluate the efficacy and safety of AZD7798 subcutaneous (SC) every 4 weeks (Q4W) in participants with moderate to severe Crohns disease. The objectives of this study will be evaluated in a broad Crohns disease population, and in predefined subpopulations, according to the areas of active inflammation (ileal/ileocecal [L1], colonic [L2], ileocolonic [L3]).

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Miles Sparrow

Key inclusion data

Eligible participants must be 18 to 80 years of age inclusive and have a diagnosis of Crohns disease established with verifiable clinical, AND at least one of imaging, endoscopic, and/or histopathologic evidence.