RECRUITING

Phase IIa Study Evaluating AZD7798 in Crohn's Disease

Conditions

Moderate to Severe Crohn's Disease Crohn disease Inflammation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Double-blind, Placebo-controlled Phase IIa Study to Evaluate the Efficacy and Safety of AZD7798 in Patients With Moderate to Severe Crohn's Disease

Quick Facts

Study Start:2024-08-28

Study Completion:2027-05-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06450197

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 1. Intolerance or inadequate response to conventional treatment (oral corticosteroid, azathioprine, 6-mercaptopurine, or methotrexate), biologics, or other approved advanced therapy (eg, JAK inhibitors) OR 2. 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.	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: 1. History of toxic megacolon 2. Diagnosis of peritonitis or need for treatment of peritonitis 3. 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 1. An anti-TNF biologic within 8 weeks prior to screening endoscopy visit 2. Any biologic targeting immune response other than an anti-TNF within 12 weeks prior to screening endoscopy visit 3. Other advanced small molecule treatments for Crohn's disease within 4 weeks prior to screening endoscopy visit 4. Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or tacrolimus (FK-506) within 4 weeks prior to screening endoscopy visit 5. Treatment with apheresis within 4 weeks prior to screening endoscopy visit 6. Administration of any live vaccine within 4 weeks prior to screening endoscopy visit to end of study 7. Faecal microbiota transplantation within 4 weeks prior to screening endoscopy visit 8. Lymphocyte-depleting treatment within 12 months prior to screening endoscopy visit 9. Any previous exposure to AZD7798. 11. Any changes in dosing of the following medications prior to screening endoscopy visit as outlined: 1. 5-aminosalicylates within 2 weeks 2. Oral corticosteroids 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 appropriate course of treatment has been completed. 16. Positive diagnostic TB test at screening. 17. History of serious opportunistic infection within 12 months prior to screening endoscopy visit. 18. CMV colitis within previous 12 months prior to screening endoscopy visit. 19. Positive C. difficile toxin stool test at screening. 20. Symptomatic herpes zoster infection within 3 months prior to screening endoscopy. 21. Any identified immunodeficiency. 22. Abnormal laboratory results at screening suggesting participation may be unsafe, which will prevent the patient from completing the study, or will interfere with the interpretation of the study results. 23. Reproduction: 1. Pregnant and breastfeeding patients, or those planning to breastfeed during the study 2. FOCBP unless completely abstinent or using a highly effective contraception and barrier method of contraception. 24. Prolonged QTcF interval. 25. Clinically significant cardiovascular conditions. 26. Current malignancy or history of malignancy. 27. Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, haematological disease, hepatic disease, renal disease, gastrointestinal disease or other major disease other than active Crohn's disease. 28. Current enrolment in another interventional study or treatment with any investigational drug within 4 months prior to screening endoscopy visit. 29. Unstable lifestyle factors. 30. Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.

Inclusion Criteria

Exclusion 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:
1. Intolerance or inadequate response to conventional treatment (oral corticosteroid, azathioprine, 6-mercaptopurine, or methotrexate), biologics, or other approved advanced therapy (eg, JAK inhibitors) OR
2. 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.

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:
1. History of toxic megacolon
2. Diagnosis of peritonitis or need for treatment of peritonitis
3. 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
1. An anti-TNF biologic within 8 weeks prior to screening endoscopy visit
2. Any biologic targeting immune response other than an anti-TNF within 12 weeks prior to screening endoscopy visit
3. Other advanced small molecule treatments for Crohn's disease within 4 weeks prior to screening endoscopy visit
4. Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or tacrolimus (FK-506) within 4 weeks prior to screening endoscopy visit
5. Treatment with apheresis within 4 weeks prior to screening endoscopy visit
6. Administration of any live vaccine within 4 weeks prior to screening endoscopy visit to end of study
7. Faecal microbiota transplantation within 4 weeks prior to screening endoscopy visit
8. Lymphocyte-depleting treatment within 12 months prior to screening endoscopy visit
9. Any previous exposure to AZD7798.
11. Any changes in dosing of the following medications prior to screening endoscopy visit as outlined:
1. 5-aminosalicylates within 2 weeks
2. Oral corticosteroids 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 appropriate course of treatment has been completed.
16. Positive diagnostic TB test at screening.
17. History of serious opportunistic infection within 12 months prior to screening endoscopy visit.
18. CMV colitis within previous 12 months prior to screening endoscopy visit.
19. Positive C. difficile toxin stool test at screening.
20. Symptomatic herpes zoster infection within 3 months prior to screening endoscopy.
21. Any identified immunodeficiency.
22. Abnormal laboratory results at screening suggesting participation may be unsafe, which will prevent the patient from completing the study, or will interfere with the interpretation of the study results.
23. Reproduction:
1. Pregnant and breastfeeding patients, or those planning to breastfeed during the study
2. FOCBP unless completely abstinent or using a highly effective contraception and barrier method of contraception.
24. Prolonged QTcF interval.
25. Clinically significant cardiovascular conditions.
26. Current malignancy or history of malignancy.
27. Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, haematological disease, hepatic disease, renal disease, gastrointestinal disease or other major disease other than active Crohn's disease.
28. Current enrolment in another interventional study or treatment with any investigational drug within 4 months prior to screening endoscopy visit.
29. Unstable lifestyle factors.
30. Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479

information.center@astrazeneca.com

Study Locations (Sites)

Research Site

Phoenix, Arizona, 85054

United States

Research Site

La Jolla, California, 92037

United States

Research Site

Hamden, Connecticut, 06518

United States

Research Site

Orlando, Florida, 32825

United States

Research Site

Tampa, Florida, 33607

United States

Research Site

Idaho Falls, Idaho, 83404

United States

Research Site

Kansas City, Kansas, 66160

United States

Research Site

Ann Arbor, Michigan, 48109

United States

Research Site

Clinton Township, Michigan, 48038

United States

Research Site

Liberty, Missouri, 64068

United States

Research Site

Saint Louis, Missouri, 63156

United States

Research Site

Asheville, North Carolina, 28801

United States

Research Site

Charlotte, North Carolina, 28204

United States

Research Site

Winston-Salem, North Carolina, 27103

United States

Research Site

Cleveland, Ohio, 44195

United States

Research Site

Uniontown, Pennsylvania, 15401

United States

Research Site

Dallas, Texas, 75246

United States

Research Site

Garland, Texas, 75044

United States

Research Site

Mansfield, Texas, 76063

United States

Research Site

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-28

Study Completion Date2027-05-21

Study Record Updates

Study Start Date2024-08-28

Study Completion Date2027-05-21

Terms related to this study

Keywords Provided by Researchers

Crohn disease
Inflammation

Additional Relevant MeSH Terms

Moderate to Severe Crohn's Disease