A Phase II Study Evaluating Safety and Mucosal Repair of AZD7798 in Patients with Crohn’s Disease and an Ileostomy - Callisto

Exclusion Criteria

• - Concomitant additional gastrointestinal luminal inflammatory diseases
• -Strictures/stenoses preventing passage of endoscope throughout the specified segment
• -Short bowel syndrome
• -Within 3 months prior to screening:
• (a) Diagnosis of peritonitis or need treatment of peritonitis
• (b) 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 which are adequately drained 4 weeks prior to randomisation, and intraabdominal fistulae between bowel segments only without complications
• -Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study (partial nutrition acceptable).
• -In patients with any remaining colon and/or rectum, evidence of an increased risk of
• colorectal cancer, including:
• (a) Adenomatous colonic/rectal polyps that have not been removed
• (b) Intestinal dysplasia
• (c) Not undertaking appropriate surveillance, if indicated, for colorectal
• dysplasia/malignancy
• - 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
• patient 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:
• (a)An anti-TNF biologic within 8 weeks prior to randomisation
• (b) Any biologic targeting immune response other than an anti-TNF (including
• vedolizumab and ustekinumab) within 12 weeks prior to randomisation.
• (c) Other advanced small molecule treatments for Crohn’s disease within 4 weeks prior to randomisation
• (d) Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or
• tacrolimus within 4 weeks prior to randomisation
• (e) Treatment with apheresis (eg, Adacolumn, Cellsorba) within 4 weeks prior to
• randomisation
• (f) Administration of any live vaccine within 4 weeks prior to randomisation, or planned
• administration of any such vaccine during the study
• (g) Faecal microbiota transplantation within 4 weeks prior to randomisation
• (h) Regular intake of NSAIDs within 12 weeks prior to screening ileoscopy and during
• the study (defined as at least 3 times per week for more than 3 months; not applicable
• to daily aspirin use up to 325 mg per day)
• (i) Lymphocyte-depleting treatment, including, but not limited to rituximab, within
• 12 months prior to randomisation
• -Any changes in dosing of the following medications prior to screening ileoscopy as
• outlined
• (a) 5-aminosalicylates within 2 weeks
• (b) 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.
• -Evidence of chronic hepatitis B or C infection
• -History of TB (active or latent) unless an appropriate course of treatment has been
• completed.
• -Positive diagnostic TB test at screening.
• - History of serious opportunistic infection 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
• -Any other abnormal laboratory results at screening, 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
• - 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.
• - Clinically significant cardiovascular conditions
• -Reproduction:
• (a) Pregnant and breastfeeding patients, or those planning to breastfeed during the study
• (b) FOCBP, unless they agree to complete abstinence or to use a highly effective
• contraceptive method AND barrier method
• -Current malignancy or history of malignancy
• - 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.
• -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
• -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
• -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 randomisation in the present study.