AZD7798 for Crohn's Disease

(AMALTHEA Trial)

Recruiting at 196 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, AZD7798, to evaluate its effectiveness and safety for individuals with moderate to severe Crohn's disease, a condition that causes inflammation in the digestive tract. Participants will receive either the experimental treatment or a placebo (a harmless pill with no active ingredients) for comparison. The trial seeks individuals with Crohn's disease who have not responded well to other treatments or who cannot reduce their steroid medication without symptom recurrence. As a Phase 2 trial, it focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

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.

Is there any evidence suggesting that AZD7798 is likely to be safe for humans?

Research has shown that AZD7798 is generally safe for most people. In studies where participants took one or more doses of AZD7798, no major safety issues emerged. Some individuals experienced mild cytokine release syndrome, a mild reaction that can occur when the immune system activates. Overall, these findings suggest AZD7798 is reasonably safe for humans, but ongoing studies continue to assess its safety and effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's disease?

AZD7798 is unique because it targets the underlying inflammatory pathways in Crohn's disease differently than current treatments. Unlike standard options such as corticosteroids or biologics like TNF inhibitors, AZD7798 is designed to work by modulating specific immune responses, potentially offering a more tailored approach to controlling the disease. Researchers are excited about this treatment because it could provide a new option for patients who have not responded well to existing therapies, potentially reducing inflammation more effectively and with fewer side effects.

What evidence suggests that AZD7798 might be an effective treatment for Crohn's disease?

Research has shown that AZD7798, which participants in this trial may receive, might help people with moderate to severe Crohn's disease. This treatment reduces certain immune cells in the gut that cause inflammation. Early studies suggest that AZD7798 can lower these immune cells, potentially relieving symptoms. Although more research is needed, this approach appears promising for improving life for those with Crohn's. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06450197

Phase IIa Study Evaluating AZD7798 in Crohn's Disease This is a randomised, double-blind, parallel group, placebo-controlled Phase IIa study designed to evaluate the efficacy and safety of AZD7798 in ...

2. academic.oup.com academic.oup.com/ecco-jcc/article/19/Supplement_1/i2048/7971861

effects of the CCR9-depleting monoclonal antibody AZD7798 An ongoing PET imaging study will assess the effects of AZD7798 on CCR9+ cell depletion/repletion in the gut following multiple doses, ...

3. clinicaltrials.eu clinicaltrials.eu/inn/azd7798/

AZD7798: A Promising New Treatment for Crohn's Disease These trials aim to evaluate the safety, efficacy, and potential benefits of AZD7798 in patients with moderate to severe Crohn's disease, including those with ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06450197/phase-iia-study-evaluating-azd7798-in-crohns-disease

Phase IIa Study Evaluating AZD7798 in Crohn's Disease This is a randomised, double-blind, parallel group, placebo-controlled Phase IIa study designed to evaluate the efficacy and safety of AZD7798 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05452304

Study Details | NCT05452304 | AZD7798 Safety, ... Part 1a: This is a First-In-Human (FIH), single ascending dose (SAD) sequential group study. Up to 7 dose levels of AZD7798 are planned to be investigated.

6. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D9690C00006

Study Evaluating AZD7798 for treatment in Crohn's ... The purpose of this study is to evaluate safety, tolerability, and effect on mucosal repair of AZD7798 compared with placebo in participants with active ...