← Back to Search

Anti-inflammatory

AZD7798 for Crohn's Disease (AMALTHEA Trial)

Phase 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ileal/ileocecal (L1), colonic (L2), or ileocolonic (L3) disease
Age between 18 to 80 years
Must not have
Extensive prior gastrointestinal surgical interventions
Recent treatments including anti-TNF biologics, other biologics targeting immune response, advanced small molecule treatments, specific medications, apheresis, live vaccines, faecal microbiota transplantation, lymphocyte-depleting treatment, and previous exposure to AZD7798
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 85 days

Summary

"This trial will test a new drug called AZD7798 in people with moderate to severe Crohn's disease. It will be a fair study where neither the participants nor the researchers know who is receiving

Who is the study for?
Adults aged 18-80 with moderate to severe Crohn's Disease, who haven't responded well to conventional treatments or are corticosteroid-dependent. Participants must have a confirmed diagnosis and be able to consent. Excluded are those recently on certain advanced treatments, pregnant or breastfeeding individuals, people with significant heart conditions or other major diseases, and anyone currently in another study.
What is being tested?
The trial is testing AZD7798 against a placebo in patients with Crohn's Disease. It's randomized (participants are put into groups by chance), double-blind (neither the researchers nor participants know who gets the real treatment), parallel group (different groups receive different treatments at the same time), and placebo-controlled (one group receives an inactive substance).
What are the potential side effects?
While specific side effects of AZD7798 aren't listed here, common side effects for medications treating Crohn’s can include immune system suppression leading to increased infection risk, infusion reactions, gastrointestinal symptoms like nausea or abdominal pain, headaches, and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My Crohn's disease affects my ileum, colon, or both.
Select...
I am between 18 and 80 years old.
Select...
I have moderate to severe active Crohn's disease.
Select...
I have Crohn's disease and standard treatments haven't worked well for me.
Select...
I have been diagnosed with Crohn's disease based on tests and doctor's findings.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had major surgery on my digestive system.
Select...
I have not recently used specific advanced treatments or received certain vaccines.
Select...
I do not have any active infections or a history of serious infections.
Select...
I may have another inflammatory bowel disease besides the one being treated.
Select...
I have blockages in my bowel that prevent thorough examination.
Select...
I might need surgery for my Crohn's disease before the study ends.
Select...
I have had serious intestinal issues like toxic megacolon or bowel perforation.
Select...
I regularly use anti-inflammatory medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 85 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 85 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CDAI remission
Secondary study objectives
CDAI response
CDAI score change from baseline
Endoscopic remission
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD7798Experimental Treatment1 Intervention
AZD7798
Group II: PlaceboPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,400 Previous Clinical Trials
289,122,533 Total Patients Enrolled
~128 spots leftby Apr 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top