AZD7798 for Crohn's Disease

(AMALTHEA Trial)

Recruiting at 159 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AstraZeneca

Must not be taking: Anti-TNF biologics, Cyclosporine, Thalidomide, others

Disqualifiers: Other IBD, Bowel stenoses, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

192 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop all current medications, but certain treatments must be stopped before joining. For example, some biologics and advanced therapies need to be stopped weeks before the screening visit. It's best to discuss your specific medications with the trial team.

What is the purpose of this trial?

This is a randomised, double-blind, parallel group, placebo-controlled Phase IIa study designed to evaluate the efficacy and safety of AZD7798 in participants with moderate to severe Crohn's disease.

Eligibility Criteria

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.

Inclusion Criteria

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

I am able to understand and willing to sign a consent form.

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

Exclusion Criteria

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

Reproduction-related criteria including pregnancy, breastfeeding, contraception, prolonged QTcF interval

I don't have major heart issues, other cancers, or major diseases besides Crohn's. I'm not in another study or taking experimental drugs, and I'm not under legal supervision.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD7798 or placebo in a double-blind, placebo-controlled setting to evaluate efficacy and safety

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including serum AZD7798 concentration and anti-drug antibody response

36 weeks

Treatment Details

Interventions

• AZD7798

Trial Overview 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).

Participant Groups

Group I: AZD7798 Experimental Treatment 1 Intervention

AZD7798

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology