AstraZeneca Initiates Phase II Trial of AZD7798 for Crohn's Disease Mucosal Repair

Key Insights

• AstraZeneca has launched the CALLISTO Phase II clinical trial to evaluate AZD7798, an experimental treatment targeting mucosal repair in patients with active ileal Crohn's disease and ileostomy.
• The randomized, placebo-controlled study will enroll approximately 30 participants globally for a 12-week induction period followed by a 40-week open-label maintenance phase.
• The trial began recruitment on December 11, 2024, with primary completion expected after the initial 12-week induction phase.

AstraZeneca has initiated a Phase II clinical trial evaluating AZD7798, an experimental treatment designed to improve mucosal repair in patients with active ileal Crohn's disease and an ileostomy. The study, formally titled "A Participant- and Investigator-blind, Randomized, Placebo-controlled Phase II Study to Evaluate Safety, Tolerability, and Mucosal Repair With AZD7798 in Patients With Active Ileal Crohn's Disease and an Ileostomy (CALLISTO)," began recruitment on December 11, 2024.

Study Design and Objectives

The CALLISTO trial employs a randomized, parallel-group design with triple masking involving participants, care providers, and investigators to ensure unbiased results. The primary objective is to evaluate the safety, tolerability, and effect on mucosal repair of AZD7798 compared with placebo in this specific patient population.

Approximately 30 participants will be randomized globally to receive either AZD7798 or placebo during the 12-week participant- and investigator-blind induction period. The study design includes multiple phases: a screening period, the 12-week induction period, a 40-week open-label maintenance period, and a follow-up period.

Treatment Protocol and Timeline

Following the initial 12-week induction phase, all eligible participants will enter the 40-week open-label maintenance period, during which all patients will receive AZD7798. Follow-up visits are scheduled at 8 weeks and 18 weeks after the last dose of study intervention, whether administered during the induction period or the open-label maintenance phase.

Primary completion is expected after the 12-week induction phase, with the last study update submitted on July 15, 2025, indicating ongoing recruitment and progress.

Market and Clinical Implications

The initiation of this trial demonstrates AstraZeneca's commitment to developing innovative treatments in the gastrointestinal sector. Success in this trial may enhance investor confidence and position AstraZeneca favorably against competitors in the Crohn's disease treatment market.

The study specifically targets patients with active ileal Crohn's disease and an ileostomy, representing a focused approach to addressing mucosal repair in this patient population. The trial is currently recruiting participants, with detailed information available through clinical trial registries.