Last updated 31 days ago

Phase IIa Study Evaluating AZD7798 in Crohn's Disease

192 patients around the world

Available in Spain, Chile, Brazil, Argentina, United States, Mexico

AstraZeneca

192Patients around the world

This study is for people with

Crohn's disease

Moderate to severe crohn's disease

Requirements for the patient

To 80 Years

All Gender

Medical requirements

: 18 to 80 years of age.
Diagnosis of Crohn's disease established with verifiable clinical, imaging, endoscopic and/or histopathologic evidence.
Moderate to severe active Crohn's disease.
Ileal/ileocecal (L1), colonic (L2), or ileocolonic (L3) disease, as classified based on the localisation of active inflammation.
Capable of giving signed informed consent.
A history of at least one of:
Intolerance or inadequate response to conventional treatment (oral corticosteroid, azathioprine, 6-mercaptopurine, or methotrexate), biologics, or other approved advanced therapy (eg, JAK inhibitors) OR
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.

: Evidence, or clinical suspicion, of other forms of IBD or concomitant additional active gastrointestinal luminal inflammatory diseases.
Known symptomatic strictures or bowel stenoses or strictures preventing passage of endoscope throughout the colon.
Any complications of Crohn's disease where surgery is anticipated or planned prior to end of study treatment.
Evidence of extensive prior gastrointestinal surgical interventions.
Within 3 months prior to screening endoscopy visit:
History of toxic megacolon
Diagnosis of peritonitis or need for treatment of peritonitis
Bowel perforation or evidence of obstruction.
Undrained fistula or abscess, including intrabdominal abscesses.
Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study.
Evidence of an increased risk of colorectal cancer.
Symptomatic oral Crohn's disease within one year.
Any of the following treatments within the specified time period prior to screening endoscopy visit
An anti-TNF biologic within 8 weeks prior to screening endoscopy visit
Any biologic targeting immune response other than an anti-TNF within 12 weeks prior to screening endoscopy visit
Other advanced small molecule treatments for Crohn's disease within 4 weeks prior to screening endoscopy visit
Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or tacrolimus (FK-506) within 4 weeks prior to screening endoscopy visit
Treatment with apheresis within 4 weeks prior to screening endoscopy visit
Administration of any live vaccine within 4 weeks prior to screening endoscopy visit to end of study
Faecal microbiota transplantation within 4 weeks prior to screening endoscopy visit
Lymphocyte-depleting treatment within 12 months prior to screening endoscopy visit
Any previous exposure to AZD7798.
Any changes in dosing of the following medications prior to screening endoscopy visit as outlined:
5-aminosalicylates within 2 weeks
Oral corticosteroids within 2 weeks:
(i) Prednisolone
(ii) Budesonide
(c) Immunomodulators within 4 weeks
(d) Antibiotic therapy for the treatment of Crohn's disease
(e) Probiotics within 2 weeks.
Known or suspected history of chronic use of nonsteroidal anti-inflammatory drugs.
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.
Evidence of chronic HBV or HCV.
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 endoscopy visit.
CMV colitis within previous 12 months prior to screening endoscopy visit.
Positive C. difficile toxin stool test at screening.
Symptomatic herpes zoster infection within 3 months prior to screening endoscopy.
Any identified immunodeficiency.
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.
Reproduction:
Pregnant and breastfeeding patients, or those planning to breastfeed during the study
FOCBP unless completely abstinent or using a highly effective contraception and barrier method of contraception.
Prolonged QTcF interval.
Clinically significant cardiovascular conditions.
Current malignancy or history of malignancy.
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.
Current enrolment in another interventional study or treatment with any investigational drug within 4 months prior to screening endoscopy visit.
Unstable lifestyle factors.
Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.

StudyAMALTHEA

SponsorAstraZeneca

Conditions

Moderate to severe crohn's disease

Requirements

To 80 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06450197