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Evaluating AZD7798 for treating moderate to severe Crohn's disease

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

PHASE2 · AstraZeneca · NCT06450197

This study is testing a new medication called AZD7798 to see if it can help adults with moderate to severe Crohn's disease who haven't found relief with other treatments.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment192 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorAstraZeneca (industry)
Drugs / interventionsmethotrexate
Locations191 sites (Phoenix, Arizona and 190 other locations)
Trial IDNCT06450197 on ClinicalTrials.gov

What this trial studies

This Phase IIa study is a randomized, double-blind, parallel group, placebo-controlled trial aimed at assessing the efficacy and safety of AZD7798 in patients suffering from moderate to severe Crohn's disease. Participants will be monitored for their response to the treatment compared to a placebo group. The study includes adults aged 18 to 80 who have a confirmed diagnosis of Crohn's disease and have not adequately responded to conventional therapies. The trial will focus on various disease locations, including ileal, colonic, and ileocolonic areas.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with moderate to severe active Crohn's disease and a history of inadequate response to conventional treatments.

Not a fit: Patients with other forms of inflammatory bowel disease or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with moderate to severe Crohn's disease who have not responded to existing treatments.

How similar studies have performed: Other studies have shown promise in treating Crohn's disease with novel therapies, but the specific approach of AZD7798 is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 18 to 80 years of age.
2. Diagnosis of Crohn's disease established with verifiable clinical, AND at least one of 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 equivalent dosing without recurrent active disease) for the treatment of Crohn's disease.

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:

   1. History of toxic megacolon
   2. Diagnosis of peritonitis or need for treatment of peritonitis
   3. Bowel perforation or evidence of obstruction.
6. 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.
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 or stable doses of steroids exceeding the following dose equivalents:

    (i) Systemic steroids \> 20 mg/day or prednisolone equivalent (ii) Locally targeted steroids 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.
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.
31. Investigator concerns regarding patient's willingness and ability to attend all study visits, comply with the study procedures, read in order to complete questionnaires, or to complete the study period

Where this trial is running

Phoenix, Arizona and 190 other locations

+141 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Moderate to Severe Crohn's Disease, Crohn disease, Inflammation

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.