Active — Not RecruitingPhase 2

Phase IIa Study Evaluating AZD7798 in Crohn's Disease

United States120 participantsStarted 2024-08-28

Plain-language summary

This is a randomised, double-blind, parallel group, placebo-controlled Phase IIa study designed to evaluate the efficacy and safety of AZD7798 in participants with moderate to severe Crohn's disease.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 18 to 80 years of age.
✓. Diagnosis of Crohn's disease established with verifiable clinical, AND at least one of imaging, endoscopic and/or histopathologic evidence.
✓. Moderate to severe active Crohn's disease.
✓. Ileal/ileocecal (L1), colonic (L2), or ileocolonic (L3) disease, as classified based on the localisation of active inflammation.
✓. Capable of giving signed informed consent.
✓. A history of at least one of:
✓. Intolerance or inadequate response to conventional treatment (oral corticosteroid, azathioprine, 6-mercaptopurine, or methotrexate), biologics, or other approved advanced therapy (eg, JAK inhibitors) OR
✓. Corticosteroid dependency (defined as inability to taper below budesonide 6 mg/day or prednisolone 10 mg/day equivalent dosing without recurrent active disease) for the treatment of Crohn's disease.

Exclusion criteria

✕. Evidence, or clinical suspicion, of other forms of IBD or concomitant additional active gastrointestinal luminal inflammatory diseases.
✕. Symptomatic strictures or bowel stenoses, or strictures preventing passage of endoscope throughout the colon (including at screening endoscopy).
✕. Any complications of Crohn's disease where surgery is anticipated or planned prior to end of study treatment.
✕. Evidence of extensive prior gastrointestinal surgical interventions.
✕. Within 3 months prior to screening endoscopy visit:
✕. History of toxic megacolon
✕. Diagnosis of peritonitis or need for treatment of peritonitis
✕. Bowel perforation or evidence of obstruction.

What they're measuring

CDAI remission

Timeframe: Week 12

Trial details

NCT IDNCT06450197

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-01

View on ClinicalTrials.gov More Moderate to Severe Crohn's Disease trials