Crohn's DiseasePhase 2CALLISTONCT06681324
Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy
A Phase 2 study testing AZD7798 in people with Crohn's Disease, run by AstraZeneca at 17 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- AZD7798
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 17 sitesin 7 countries
- Study dates
- 11 Dec 2024to 3 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- Diagnosis of peritonitis or need treatment of peritonitis
- Bowel perforation or evidence of obstruction
Show all 71Show fewer
- 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:
- Adenomatous colonic/rectal polyps that have not been removed
- Intestinal dysplasia
- Not undertaking appropriate surveillance, if indicated, for colorectal dysplasia/malignancy
- 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:
- An anti-TNF biologic within 8 weeks prior to randomization, unless therapeutic drug monitoring is performed, and drug concentrations are undetectable.
- 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.
- Other advanced small molecule treatments for Crohn's disease (including JAK inhibitors or S1P modulators) within 4 weeks prior to randomization
- Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or tacrolimus within 4 weeks prior to randomization
- Treatment with apheresis (eg, Adacolumn, Cellsorba) within 4 weeks prior to randomization
- Administration of any live vaccine within 4 weeks prior to randomization, or planned administration of any such vaccine during the study
- Faecal microbiota transplantation within 4 weeks prior to randomization
- 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)
- 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
- 5-aminosalicylates within 2 weeks
- Oral corticosteroids within 2 weeks. Also excluded if on stable dosing of steroids exceeding the following dose equivalents:
- 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:
- HBV: HBsAg positive or HBcAb positive
- 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:
- HIV infection (patients with positive results of HIV testing by the central laboratory will be excluded)
- Splenectomy
- 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
- Primary immune deficiency diseases, excluding selective IgA deficiency.
- Abnormal laboratory results at screening:
- Haemoglobin < 8 g/dL
- 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
- Lymphocytes < 500/μL (or < 0.5 × 109/L)
- 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%)
- eGFR according to CKD-EPI formula < 30 mL/min
- 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:
- 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
- Decompensated heart failure requiring hospitalisation, or Class III/IV heart failure, within 6 months prior to screening
- 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
- 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:
- Pregnant and breastfeeding participants, or those planning to breastfeed during the study
- 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:
- 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;
- 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.
Trial locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
United Kingdom5 sites
Research Site
Birmingham, B15 2GW
Research Site
Cambridge, CB2 0XY
Research Site
London, E1 1FR
Research Site
London, NW10 7NS
Research Site
London, WC1E 6AG
Italy3 sites
Research Site
Padova, 35121
Research Site
Roma, 00168
Research Site
Rozzano, 20089
Ukraine3 sites
Research Site
Kyiv, 02002
Research Site
Kyiv, 04210
Research Site
Vinnytsia, 21029
Netherlands2 sites
Research Site
Amsterdam, 1081 HV
Research Site
Nijmegen, 6525 GA
About this study
Official title: 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)
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.
Read the detailed description
This is a participant-and investigator-blind, randomized, parallel-group, placebo controlled phase II study designed to evaluate safety, tolerability, and mucosal repair with AZD7798 in participants with active ileal Crohn's disease and an ileostomy. This study will include a screening period, an induction period, an open-label maintenance period, and a follow-up period. Approximately 30 participants will be randomized globally to receive either AZD7798 or placebo during 12-week participant- and investigator- blind induction period. At week 12 after induction period, all eligible participants will enter 40-week open label maintenance period. Follow-up visits will take place 8 weeks and 18 weeks after the last dose of study intervention, whether this occurs during the induction period or the open-label maintenance period.
- Conditions
- Crohn's Disease
- Being tested
- AZD7798, Placebo
- Keywords
- Crohn's disease, ileostomy, inflammation, small bowel, stoma
- Medical subject headings
- Crohn Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7798Drug
AZD7798
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| AZD7798 | Experimental | AZD7798 Receives: Drug: AZD7798 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Summary of any adverse events and also by MedDRA SOC and Preferred term
Measured: from Week 0 to Week 12
Number of participants with abnormal Vital signs: Blood pressure
Systolic and diastolic blood pressure will be summarized by descriptive statistics
Measured: from Week 0 to Week 12
Number of participants with abnormal Vital signs: Pulse rate
Pulse rate will be summarized by descriptive statistics
Measured: from Week 0 to Week 12
Number of participants with abnormal values in haematology: complete blood count (CBC)
The variables platelet count, red blood cell (RBC) count, haemoglobin, haematocrit will be summarized with descriptive statistics
Measured: from Week 0 to Week 12
Number of participants with abnormal values in haematology: white blood cell (WBC) count
The variables neutrophils, lymphocytes, monocytes, eosinophils, and basophils will be summarized with descriptive statistics
Measured: from Week 0 to Week 12
Number of participants with abnormal values in haematology: RBC
The variables mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH) and percentage of reticulocytes will be summarized with descriptive statistics
Measured: from Week 0 to Week 12
Number of participants with abnormal values in clinical chemistry: kidney function
The variables creatinine and blood urea nitrogen (BUN) will be summarized with descriptive statistics
Measured: from Week 0 to Week 12
Number of participants with abnormal values in clinical chemistry: electrolytes
The variables potassium, sodium, and calcium will be summarized with descriptive statistics
Measured: from Week 0 to Week 12
Number of participants with abnormal values in clinical chemistry: liver function
The variables ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), and ALP (alkaline phosphatase), and albumin will be summarized with descriptive statistics
Measured: from Week 0 to Week 12
Number of participants with abnormal values in clinical chemistry: hs-CRP
The variable hs-C-reactive protein will be summarized with descriptive statistics
Measured: from Week 0 to Week 12
Number of participants with abnormal values in clinical chemistry: glucose
The variable glucose will be summarized with descriptive statistics
Measured: from Week 0 to Week 12
Number of participants with abnormal values in ECG readings
12-lead ECGs will be obtained using an ECG machine, that automatically measures RR/HR, PR, QRS, QT and Corrected QT (QTc) intervals, and summarized with descriptive statistics
Measured: from Week 0 to Week 12
Secondary outcomes (18)
Difference in mean change from baseline in endoscopic score between active and placebo
Simple Endoscopic Score for Crohn's Disease (SES-CD) is based on the evaluation of ileum, and the presence and size of ulcerations and the extent of the inflammatory area and stenosis are assessed. The segment is scored from 0 to 12, higher scores indicating more active disease
Measured: Week 12
Number of participants with endoscopic response
Endoscopic response is defined as ≥ 50% decrease from baseline in SES-CD total score and based on the evaluation of ileum and the presence and size of ulcerations and the extent of the inflammatory area and stenosis are assessed. The segment is scored from 0 to 12, higher scores indicating more active disease
Measured: Week 12
Number of participants with endoscopic remission
Endoscopic remission is defined as SES-CD total score < 4 and at least 2 point reduction from baseline with no sub score > 1 in any individual variable. SES-CD is based on the evaluation of ileum, and the presence and size of ulcerations and the extent of the inflammatory area and stenosis are assessed. The segment is scored from 0 to 12, higher scores indicating more active disease
Measured: Week 12
Serum AZD7798 concentration
Serum AZD7798 concentration (PK)
Measured: up to 52 Weeks
Incidence of anti-drug antibody response
Incidence of anti-drug antibody (ADA) response - number and percentages with a positive ADA result
Measured: up to 52 Weeks
Titre of anti-drug antibody response
Titre of anti-drug antibody (ADA) response - immunogenicity titre will be summarized descriptively as a continuous variable, only for ADA positive tests
Measured: up to 52 Weeks
Number of participants with adverse events in active treatment
Summary of any adverse events and also by MedDRA SOC and Preferred term
Measured: from Week 12 to Week 52
Number of participants with abnormal vital signs: Blood pressure
Systolic and diastolic blood pressure will be summarized by descriptive statistics
Measured: from Week 12 to Week 52
Number of participants with abnormal vital signs: Pulse rate
Pulse rate will be summarized by descriptive statistics
Measured: from Week 12 to Week 52
Number of participants with abnormal values in haematology: complete blood count (CBC)
The variables platelet count, red blood cell (RBC) count, haemoglobin, haematocrit will be summarized with descriptive statistics
Measured: from Week 12 to Week 52
Number of participants with abnormal values in haematology: white blood cell (WBC) count
The variables neutrophils, lymphocytes, monocytes, eosinophils, and basophils will be summarized with descriptive statistics
Measured: from Week 12 to Week 52
Number of participants with abnormal values in haematology: RBC
The variables mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH) and percentage of reticulocytes will be summarized with descriptive statistics
Measured: from Week 12 to Week 52
Number of participants with abnormal values in clinical chemistry: kidney function
The variables creatinine and blood urea nitrogen (BUN) will be summarized with descriptive statistics
Measured: from week 12 to week 52
Number of participants with abnormal values in clinical chemistry: electrolytes
The variables potassium, sodium, and calcium will be summarized with descriptive statistics
Measured: from Week 12 to Week 52
Number of participants with abnormal values in clinical chemistry: liver function
The variables ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), and ALP (alkaline phosphatase), and albumin will be summarized with descriptive statistics
Measured: from Week 12 to Week 52
Number of participants with abnormal values in clinical chemistry: hs-CRP
The variable hs-C-reactive protein will be summarized with descriptive statistics
Measured: from Week 12 to Week 52
Number of participants with abnormal values in clinical chemistry: glucose
The variable glucose will be summarized with descriptive statistics
Measured: from Week 12 to Week 52
Number of participants with abnormal values in ECG readings
12-lead ECGs will be obtained using an ECG machine, that automatically measures RR/HR, PR, QRS, QT and Corrected QT (QTc) intervals, and summarized with descriptive statistics
Measured: from week 12 to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start11 Dec 2024
- Primary completion10 Aug 2026
- Study completion3 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 2:1 to receive either AZD7798 or placebo during 12-week participant- and Investigator- blind induction period. At week 12 after induction period, all eligible participants will enter 40-week open label maintenance period.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681324
- Sponsor's protocol ID
- D9690C00006
- Acronym
- CALLISTO
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06681324
- Acronym / sponsor ID
- CALLISTO / D9690C00006
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, ileostomy, inflammation, small bowel, stoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 3 Sep 2027 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a participant-and investigator-blind, randomized, parallel-group, placebo controlled phase II study designed to evaluate safety, tolerability, and mucosal repair with AZD7798 in participants with active ileal Crohn's disease and an ileostomy. This study will include a screening period, an induction period, an open-label maintenance period, and a follow-up period. Approximately 30 participants will be randomized globally to receive either AZD7798 or placebo during 12-week participant- and investigator- blind induction period. At week 12 after induction period, all eligible participants will enter 40-week open label maintenance period. Follow-up visits will take place 8 weeks and 18 weeks after the last dose of study intervention, whether this occurs during the induction period or the open-label maintenance period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomized 2:1 to receive either AZD7798 or placebo during 12-week participant- and Investigator- blind induction period. At week 12 after induction period, all eligible participants will enter 40-week open label maintenance period.
| Arm | Type | Receives |
|---|---|---|
| AZD7798 | Experimental | Drug: AZD7798AZD7798 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (71 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD7798AZD7798 | Drug | AZD7798 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Number of participants with adverse events
Time frame: from Week 0 to Week 12
Summary of any adverse events and also by MedDRA SOC and Preferred term
Number of participants with abnormal Vital signs: Blood pressure
Time frame: from Week 0 to Week 12
Systolic and diastolic blood pressure will be summarized by descriptive statistics
Number of participants with abnormal Vital signs: Pulse rate
Time frame: from Week 0 to Week 12
Pulse rate will be summarized by descriptive statistics
Number of participants with abnormal values in haematology: complete blood count (CBC)
Time frame: from Week 0 to Week 12
The variables platelet count, red blood cell (RBC) count, haemoglobin, haematocrit will be summarized with descriptive statistics
Number of participants with abnormal values in haematology: white blood cell (WBC) count
Time frame: from Week 0 to Week 12
The variables neutrophils, lymphocytes, monocytes, eosinophils, and basophils will be summarized with descriptive statistics
Number of participants with abnormal values in haematology: RBC
Time frame: from Week 0 to Week 12
The variables mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH) and percentage of reticulocytes will be summarized with descriptive statistics
Number of participants with abnormal values in clinical chemistry: kidney function
Time frame: from Week 0 to Week 12
The variables creatinine and blood urea nitrogen (BUN) will be summarized with descriptive statistics
Number of participants with abnormal values in clinical chemistry: electrolytes
Time frame: from Week 0 to Week 12
The variables potassium, sodium, and calcium will be summarized with descriptive statistics
Number of participants with abnormal values in clinical chemistry: liver function
Time frame: from Week 0 to Week 12
The variables ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), and ALP (alkaline phosphatase), and albumin will be summarized with descriptive statistics
Number of participants with abnormal values in clinical chemistry: hs-CRP
Time frame: from Week 0 to Week 12
The variable hs-C-reactive protein will be summarized with descriptive statistics
Number of participants with abnormal values in clinical chemistry: glucose
Time frame: from Week 0 to Week 12
The variable glucose will be summarized with descriptive statistics
Number of participants with abnormal values in ECG readings
Time frame: from Week 0 to Week 12
12-lead ECGs will be obtained using an ECG machine, that automatically measures RR/HR, PR, QRS, QT and Corrected QT (QTc) intervals, and summarized with descriptive statistics
18 secondary outcomes
Difference in mean change from baseline in endoscopic score between active and placebo
Time frame: Week 12
Number of participants with endoscopic response
Time frame: Week 12
Number of participants with endoscopic remission
Time frame: Week 12
Serum AZD7798 concentration
Time frame: up to 52 Weeks
Incidence of anti-drug antibody response
Time frame: up to 52 Weeks
Titre of anti-drug antibody response
Time frame: up to 52 Weeks
Number of participants with adverse events in active treatment
Time frame: from Week 12 to Week 52
Number of participants with abnormal vital signs: Blood pressure
Time frame: from Week 12 to Week 52
Number of participants with abnormal vital signs: Pulse rate
Time frame: from Week 12 to Week 52
Number of participants with abnormal values in haematology: complete blood count (CBC)
Time frame: from Week 12 to Week 52
Number of participants with abnormal values in haematology: white blood cell (WBC) count
Time frame: from Week 12 to Week 52
Number of participants with abnormal values in haematology: RBC
Time frame: from Week 12 to Week 52
Number of participants with abnormal values in clinical chemistry: kidney function
Time frame: from week 12 to week 52
Number of participants with abnormal values in clinical chemistry: electrolytes
Time frame: from Week 12 to Week 52
Number of participants with abnormal values in clinical chemistry: liver function
Time frame: from Week 12 to Week 52
Number of participants with abnormal values in clinical chemistry: hs-CRP
Time frame: from Week 12 to Week 52
Number of participants with abnormal values in clinical chemistry: glucose
Time frame: from Week 12 to Week 52
Number of participants with abnormal values in ECG readings
Time frame: from week 12 to week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD7798 in people with Crohn's Disease, run by AstraZeneca at 17 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 71 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom, Italy, Ukraine, Netherlands, Sweden and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: from Week 0 to Week 12). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.