Moderate to Severe Crohn's Disease
Conditions
Interventions
AZD7798 or Placebo
Sponsors
Ageishi Yuji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 to 80 years of age. 2. Diagnosis of Crohn's disease established with verifiable clinical, imaging, endoscopic and/or histopathologic evidence. 3. Moderate to severe active Crohn's disease. 4. Ileal/ileocecal (L1), colonic (L2), or ileocolonic (L3) disease, as classified based on the localisation of active inflammation. 5. Capable of giving signed informed consent. 6. A history of at least one of: a. Intolerance or inadequate response to conventional treatment (oral corticosteroid, azathioprine, 6-mercaptopurine, or methotrexate), biologics, or other approved advanced therapy (eg, JAK inhibitors) OR b. Corticosteroid dependency (defined as inability to taper below budesonide 6 mg/day or prednisolone 10 mg/day without recurrent active disease) for the treatment of Crohn's disease.
Exclusion criteria
Exclusion criteria: 1. Evidence, or clinical suspicion, of other forms of IBD or concomitant additional active gastrointestinal luminal inflammatory diseases. 2. Known symptomatic strictures or bowel stenoses or strictures preventing passage of endoscope throughout the colon. 3. Any complications of Crohn's disease where surgery is anticipated or planned prior to end of study treatment. 4. Evidence of extensive prior gastrointestinal surgical interventions. 5. Within 3 months prior to screening endoscopy visit: a. History of toxic megacolon b. Diagnosis of peritonitis or need for treatment of peritonitis c. Bowel perforation or evidence of obstruction. 6. Undrained fistula or abscess, including intrabdominal abscesses. 7. Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study. 8. Evidence of an increased risk of colorectal cancer. 9. Symptomatic oral Crohn's disease within one year. 10. Any of the following treatments within the specified time period prior to screening endoscopy visit a. An anti-TNF biologic within 8 weeks prior to screening endoscopy visit b. Any biologic targeting immune response other than an anti-TNF within 12 weeks prior to screening endoscopy visit c. Other advanced small molecule treatments for Crohn's disease within 4 weeks prior to screening endoscopy visit d. Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or tacrolimus (FK-506) within 4 weeks prior to screening endoscopy visit e. Treatment with apheresis within 4 weeks prior to screening endoscopy visit f. Administration of any live vaccine within 4 weeks prior to screening endoscopy visit to end of study g. Faecal microbiota transplantation within 4 weeks prior to screening endoscopy visit h. Lymphocyte-depleting treatment within 12 months prior to screening endoscopy visit i.Any previous exposure to AZD7798. 11. Any 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: (i) Prednisolone (ii) Budesonide (c) Immunomodulators within 4 weeks (d) Antibiotic therapy for the treatment of Crohn's disease (e) Probiotics within 2 weeks. 12. Known or suspected history of chronic use of nonsteroidal anti-inflammatory drugs. 13. 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. 14. Evidence of chronic HBV or HCV. 15. History of TB (active or latent) unless an appropr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CDAI remission [ Time Frame: Week 12 ] Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. It is based on: number of loose stools, abdominal pain, general well-being, extraintestinal complications, antidiarrheal agents used in the previous 7 days, abdominal mass felt on palpation, hematocrit and body weight | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, France, Germany, Hungary, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Romania, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United States of America, Vietnam
Contacts
Public ContactYuji Ageishi
Astrazeneka K.K
Outcome results
None listed