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Anti-inflammatory

AZD7798 for Crohn's Disease (AMALTHEA Trial)

Phase 2

Waitlist Available

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

Awards & highlights

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

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My Crohn's disease affects my ileum, colon, or both.

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I am between 18 and 80 years old.

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I have moderate to severe active Crohn's disease.

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I have Crohn's disease and standard treatments haven't worked well for me.

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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:

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I have had major surgery on my digestive system.

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I have not recently used specific advanced treatments or received certain vaccines.

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I do not have any active infections or a history of serious infections.

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I may have another inflammatory bowel disease besides the one being treated.

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I have blockages in my bowel that prevent thorough examination.

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I might need surgery for my Crohn's disease before the study ends.

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I have had serious intestinal issues like toxic megacolon or bowel perforation.

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I regularly use anti-inflammatory medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 85 days

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

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,352 Previous Clinical Trials

288,646,617 Total Patients Enrolled

~128 spots leftby Apr 2026

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