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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy

A Participant- and Investigator-blind, Randomized, Placebo-controlled Phase II Study to Evaluate Safety, Tolerability, and Mucosal Repair With AZD7798 in Patients With Active Ileal Crohn's Disease and an Ileostomy (CALLISTO)

Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy (NCT06681324) is a Phase 2 interventional studying Crohn's Disease, sponsored by AstraZeneca. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to evaluate safety, tolerability, and effect on mucosal repair of AZD7798 compared with placebo in participants with active ileal Crohn's disease and an ileostomy.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Crohn's Disease and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 18 to 80 years of age. - Diagnosis of Crohn's disease established with clinical AND at least one of imaging, endoscopic, and/or histopathologic evidence. - Ileostomy (including Kock pouch) for at least 3 months. - Prior to screening endoscopy, clinical suspicion of active ileal inflammation based on at least one of the following: previous endoscopy, imaging (CT, MRI, IUS), or FCP above upper reference limit. - Active ileal Crohn's disease as determined by active intestinal mucosal inflammation, as demonstrated on video recorded ileoscopy performed during the screening period and scored by a blinded central reader with agreement on the SES CD ≥ 4 of the ileal segment from 5 to 25 cm (20cm length) proximal to the stoma. Participants with inflammation in additional intestinal segments are not excluded. - Capable of giving signed willing to sign a consent form. Who Should NOT Join This Trial: - Concomitant additional gastrointestinal luminal inflammatory diseases including, but not limited to, infectious enteritis, ischaemic bowel, inflammation and strictures caused by previous radiation therapy - Strictures/stenoses preventing passage of endoscope throughout the specified segment (up to 25 cm of ileum) - Short bowel syndrome - Within 3 months prior to screening: 1. Diagnosis of peritonitis or need treatment of peritonitis 2. Bowel perforation or evidence of obstruction - All intrabdominal, cutaneous and perianal/perirectal abscesses and fistulae are excluded with exception of: cutaneous and perianal/perirectal abscesses and/or fistulae which are adequately drained 4 weeks prior to randomization, and intra-abdominal fistulae between bowel segments only without complications - Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study (partial nutrition acceptable). - In participants with any remaining colon and/or rectum, evidence of an increased risk of colorectal cancer, including: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 18 to 80 years of age. * Diagnosis of Crohn's disease established with clinical AND at least one of imaging, endoscopic, and/or histopathologic evidence. * Ileostomy (including Kock pouch) for at least 3 months. * Prior to screening endoscopy, clinical suspicion of active ileal inflammation based on at least one of the following: previous endoscopy, imaging (CT, MRI, IUS), or FCP above upper reference limit. * Active ileal Crohn's disease as determined by active intestinal mucosal inflammation, as demonstrated on video recorded ileoscopy performed during the screening period and scored by a blinded central reader with agreement on the SES CD ≥ 4 of the ileal segment from 5 to 25 cm (20cm length) proximal to the stoma. Participants with inflammation in additional intestinal segments are not excluded. * Capable of giving signed informed consent. Exclusion Criteria: * Concomitant additional gastrointestinal luminal inflammatory diseases including, but not limited to, infectious enteritis, ischaemic bowel, inflammation and strictures caused by previous radiation therapy * Strictures/stenoses preventing passage of endoscope throughout the specified segment (up to 25 cm of ileum) * Short bowel syndrome * Within 3 months prior to screening: 1. Diagnosis of peritonitis or need treatment of peritonitis 2. Bowel perforation or evidence of obstruction * All intrabdominal, cutaneous and perianal/perirectal abscesses and fistulae are excluded with exception of: cutaneous and perianal/perirectal abscesses and/or fistulae which are adequately drained 4 weeks prior to randomization, and intra-abdominal fistulae between bowel segments only without complications * Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study (partial nutrition acceptable). * In participants with any remaining colon and/or rectum, evidence of an increased risk of colorectal cancer, including: 1. Adenomatous colonic/rectal polyps that have not been removed 2. Intestinal dysplasia 3. Not undertaking appropriate surveillance, if indicated, for colorectal dysplasia/malignancy 4. Family history of early onset colorectal cancer, established diagnosis of HNPCC pancolitis for \>8years duration without up-to-date colorectal cancer surveillance (can be performed during screening endoscopy if considered clinically appropriate by Investigator) * Reversal of ileostomy or formation of J-pouch planned prior to end of study period. * High-output stoma (eg, \> 2000 mL/24 hours) associated with volume depletion and/or electrolyte disturbance to the extent that, in the opinion of the Investigator, it may put the participant at undue risk because of participation in the study, or impact their ability to participate in the study or interfere with the interpretation of study data. * Any of the following treatments within the specified time period: 1. An anti-TNF biologic within 8 weeks prior to randomization, unless therapeutic drug monitoring is performed, and drug concentrations are undetectable. 2. Any biologic targeting immune response other than an anti-TNF (including vedolizumab and ustekinumab) within 12 weeks prior to randomization unless validated therapeutic drug monitoring is performed, and drug concentrations are indetectable. Biologics not targeting immune response (eg, denosumab) will not be contraindicated. 3. Other advanced small molecule treatments for Crohn's disease (including JAK inhibitors or S1P modulators) within 4 weeks prior to randomization 4. Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or tacrolimus within 4 weeks prior to randomization 5. Treatment with apheresis (eg, Adacolumn, Cellsorba) within 4 weeks prior to randomization 6. Administration of any live vaccine within 4 weeks prior to randomization, or planned administration of any such vaccine during the study 7. Faecal microbiota transplantation within 4 weeks prior to randomization 8. Regular intake of NSAIDs within 12 weeks prior to screening ileoscopy and during the study (defined as at least times per week for more than 3 months; not applicable to daily aspirin use up to 325 mg per day) 9. Lymphocyte-depleting treatment, including, but not limited to rituximab, within 12 months prior to randomization * Any changes in dosing of the following medications prior to screening ileoscopy as outlined 1. 5-aminosalicylates within 2 weeks 2. Oral corticosteroids within 2 weeks. Also excluded if on stable dosing of steroids exceeding the following dose equivalents: (i) Systemic steroids \> 20 mg/day prednisolone dose or equivalent (ii) Locally targeted steroids exceeding maximum budesonide dose or equivalent \[9 mg/day\] (c) Immunomodulators (thiopurines or methotrexate) within 4 weeks (d) Antibiotic therapy for the treatment of Crohn's disease, eg, ciprofloxacin or metronidazole within 2 weeks (e) Probiotics within 2 weeks * Evidence of recent or currently active infection, including use of IV or oral antibiotics for documented infection within 30 days prior to screening. Topical antimicrobials or antimicrobials for the treatment of uncomplicated urinary tract infection may be allowed at the Medical Monitor's discretion. * Evidence of chronic hepatitis B or C infection defined as: 1. HBV: HBsAg positive or HBcAb positive 2. HCV: Positive result for HCV Ab is exclusionary unless HCV RNA is undetectable, and at least 12 weeks post anti-viral treatment of HCV (if treated). * History of TB (active or latent) unless an appropriate course of treatment has been completed. * Positive diagnostic TB test at screening (defined as positive QuantiFERON test). In cases where the QuantiFERON test is indeterminate, the patient may have the test repeated once and if their second test is negative, they will be eligible. In the event a second test is also indeterminate, the Investigator has the option to undertake PPD testing. If the PPD reaction is \<5mm, then the patient is eligible. If the reaction is ≥ 5 mm, or PPD testing is not undertaken, the patient is not eligible. If there has been a history of completed treatment for TB and, per specialist opinion, a positive QuantiFERON test reflects previous infection only and no current active or latent infection, the participant could be included. * History of serious opportunistic infection (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) within 12 months prior to screening * Symptomatic herpes zoster infection within 3 months prior to screening. * Positive C. difficile toxin test at screening. * Any identified immunodeficiency, congenital and/or acquired aetiologies, including, but not limited to: 1. HIV infection (patients with positive results of HIV testing by the central laboratory will be excluded) 2. Splenectomy 3. Previous allogenic bone marrow transplant or history of organ or cell-based transplantation (eg, islet cell transplantation or autologous stem cell transplantation) with the exception of corneal transplant 4. Primary immune deficiency diseases, excluding selective IgA deficiency. * Abnormal laboratory results at screening: 1. Haemoglobin \< 8 g/dL 2. Neutrophil count \< 1,500/μL (or \< 1.5 × 109/L); a re-test is allowed during screening in cases of mild neutropenia clinically suspected to be transient 3. Lymphocytes \< 500/μL (or \< 0.5 × 109/L) 4. Liver function tests: AST/ALT/ALP \> 2 × ULN; or TBL ≥ 1.5 × ULN (isolated bilirubin \> 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%) 5. eGFR according to CKD-EPI formula \< 30 mL/min 6. Any other abnormal laboratory results at screening, which, in the opinion of the Investigator, will prevent the participant from completing the study or will interfere with the interpretation of the study results * Prolonged QTcF interval \> 450 ms (or \> 480 ms for patients with bundle branch block) or congenital long-QT syndrome or family history of long-QT syndrome or sudden cardiac death in age \< 40 years. In case of borderline result or concern for artifact, triplicate ECGs should be collected within a 10-minute period, and the averaged value calculated for decision making. * Clinically significant cardiovascular conditions including: 1. Acute coronary syndrome (acute myocardial infarction, unstable angina), coronary intervention with percutaneous coronary intervention/coronary artery bypass surgery, stroke, transient ischaemic attack within 6 months prior to screening 2. Decompensated heart failure requiring hospitalisation, or Class III/IV heart failure, within 6 months prior to screening 3. Untreated second degree, Mobitz II or third degree atrioventricular-block, significant sinus node dysfunction/pause or therapy-requiring tachyarrhythmia. Patients with atrial fibrillation/flutter and optimally controlled ventricular rate (resting rate \< 100 bpm) may be eligible as judged by the Investigator 4. Hypertrophic cardiomyopathy or clinically significant valvular heart disease which, in the opinion of the Investigator, will prevent the patient from completing the study or will interfere with the interpretation of the study results. * Reproduction: 1. Pregnant and breastfeeding participants, or those planning to breastfeed during the study 2. FOCBP, unless they agree to complete abstinence or to use a highly effective contraceptive method AND barrier method from enrollment until 18 weeks following last drug administration. FONCBP may be included. * Current malignancy or history of malignancy, except for: 1. Basal cell carcinoma, localised squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided the patient is in remission and curative therapy was completed at least 12 months prior to screening; 2. Other non-gastrointestinal malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to screening. * Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, haematological disease, hepatic disease including large duct primary sclerosing cholangitis with jaundice, recurrent cholangitis or cirrhosis, renal disease, gastrointestinal disease, or other major disease other than active Crohn's disease. Gilbert's syndrome is not exclusionary. Small duct primary sclerosing cholangitis is not exclusionary if liver biomarkers are normal and there is no concern for cirrhosis. * Current enrolment in another interventional study or treatment with any investigational drug within 4 months (or 5 half-lives, whichever is longer) prior to screening * Unstable lifestyle factors, such as alcohol use to excess or recreational drug use, to the extent that in the opinion of the Investigator they would interfere with the ability of a patient to complete the study. * Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. * Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) * Judgement by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements. * Previous randomization in the present study. * 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. * Hypersensitivity to the IMP or any of its excipients.

Treatments Being Tested

DRUG

AZD7798

AZD7798

OTHER

Placebo

Placebo

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Research Site
Leuven, Belgium
Research Site
Padova, Italy
Research Site
Roma, Italy
Research Site
Rozzano, Italy
Research Site
Amsterdam, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Lodz, Poland
Research Site
Poznan, Poland
Research Site
Poznan, Poland
Research Site
Warsaw, Poland
Research Site
Wroclaw, Poland
Research Site
Gothenburg, Sweden
Research Site
Linköping, Sweden
Research Site
Stockholm, Sweden
Research Site
Kyiv, Ukraine
Research Site
Kyiv, Ukraine
Research Site
Vinnytsia, Ukraine
Research Site
Birmingham, United Kingdom
Research Site
Cambridge, United Kingdom
Research Site
London, United Kingdom

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06681324), the sponsor (AstraZeneca), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06681324 clinical trial studying?

The purpose of this study is to evaluate safety, tolerability, and effect on mucosal repair of AZD7798 compared with placebo in participants with active ileal Crohn's disease and an ileostomy. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06681324?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06681324?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06681324. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06681324. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.