Phase IIa Study Evaluating AZD7798 in Crohn's Disease

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Moderate to Severe Crohn's Disease

In brief

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.

Key facts

Study ID

NCT06450197

Run by

AstraZeneca

People needed

120

Starts

2024-08-28

Expected to finish

2027-05-14

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• All intrabdominal abscesses are excluded. Cutaneous and perianal/perirectal abscesses and fistulae are excluded unless adequately drained at least 4 weeks prior to screening endoscopy visit with no anticipation for surgery prior to end of study treatment.
• Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study.
• Evidence of an increased risk of colorectal cancer.
• Symptomatic oral Crohn's disease within one year.
• Any of the following treatments within the specified time period prior to screening endoscopy visit
• An anti-TNF biologic within 8 weeks prior to screening endoscopy visit
• Any biologic targeting immune response other than an anti-TNF within 12 weeks prior to screening endoscopy visit
• Other advanced small molecule treatments for Crohn's disease within 4 weeks prior to screening endoscopy visit
• Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or tacrolimus (FK-506) within 4 weeks prior to screening endoscopy visit
• Treatment with apheresis within 4 weeks prior to screening endoscopy visit
• Administration of any live vaccine within 4 weeks prior to screening endoscopy visit to end of study
• Faecal microbiota transplantation within 4 weeks prior to screening endoscopy visit
• Lymphocyte-depleting treatment within 12 months prior to screening endoscopy visit
• Any previous exposure to AZD7798.
• Any initiation or changes in dosing of the following medications prior to screening endoscopy visit as outlined: (a) 5-aminosalicylates within 2 weeks (b) Oral corticosteroids within 2 weeks or stable doses of steroids exceeding the following dose equivalents: (i) Systemic steroids > 20 mg/day or prednisolone equivalent (ii) Steroids with limited systemic effects (eg, budesonide and beclomethasone), exceeding maximum budesonide dose equivalent (9 mg/day) (c) Immunomodulators within 4 weeks (d) Antibiotic therapy for the treatment of Crohn's disease (e) Probiotics within 2 weeks.
• Chronic use of nonsteroidal anti-inflammatory drugs.
• Evidence of recent or currently active infection, including use of IV or oral antibiotics for documented infection within 30 days prior to screening endoscopy visit.

Where it is running

• Research Site — Escondido, California, United States
• Research Site — La Jolla, California, United States
• Research Site — Victorville, California, United States
• Research Site — Hamden, Connecticut, United States
• Research Site — Orlando, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Idaho Falls, Idaho, United States
• Research Site — Kansas City, Kansas, United States
• Research Site — Clinton Township, Michigan, United States
• Research Site — Liberty, Missouri, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Asheville, North Carolina, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Uniontown, Pennsylvania, United States
• Research Site — Dallas, Texas, United States
• Research Site — Garland, Texas, United States
• Research Site — Mansfield, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — CABA, Argentina
• Research Site — CABA, Argentina
• Research Site — Ciudad Autonoma de Bs As, Argentina
• Research Site — Ciudad de Buenos Aires, Argentina
• Research Site — San Miguel de Tucumán, Argentina
• Research Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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