Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of AZD7798 compared to placebo in patients with moderate to severe Crohn's disease

Fast replyInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with moderate to severe Crohn's Disease, a condition that causes inflammation in the digestive system. The study will test a new medication called AZD7798, which is given as an injection under the skin. Some participants will receive the actual medication, while others will receive a placebo.

The purpose of this study is to determine how effective and safe AZD7798 is in treating Crohn's Disease. The medication will be provided as a freeze-dried powder that is mixed into a solution before injection. The study will look at how well the treatment works in reducing disease symptoms and improving the condition of the intestines.

During the study, participants will receive subcutaneous (under the skin) injections of either AZD7798 or placebo for up to 48 weeks. The study will monitor various aspects of the disease, including symptoms such as abdominal pain and stool frequency, as well as examining the healing of the intestinal lining. Blood samples will be taken to measure the amount of medication in the body and to check for the development of antibodies against the study drug.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your eligibility for the study will be evaluated based on your Crohn's disease diagnosis and current condition.

    A video recording of your intestines (ileocolonoscopy) will be performed to assess inflammation levels.

    Your disease activity will be measured using a special score called CDAI (Crohn's Disease Activity Index).

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either AZD7798 or a placebo (inactive substance).

    Neither you nor your doctor will know which treatment you are receiving during the study.

  3. Step 3

    Treatment administration

    You will receive injections under the skin (subcutaneous) of either AZD7798 or placebo.

    The medication comes in the form of a solution prepared from a freeze-dried powder.

  4. Step 4

    Monitoring and evaluation

    Your disease activity will be regularly monitored using the CDAI score.

    The effectiveness of the treatment will be measured by checking if your CDAI score becomes less than 150 (indicating remission).

    Additional evaluations will include checking your stool frequency and abdominal pain levels.

    Another video recording of your intestines will be performed to measure changes in inflammation.

  5. Step 5

    Study duration

    The study is scheduled to run from June 2024 to May 2027.

    Blood samples will be taken to measure the amount of medication in your body and check for antibodies against the study drug.

Who can join the trial?

6 criteria

  • Age between 18 and 80 years old at the time of signing the consent form
  • Must have a confirmed diagnosis of Crohn's disease proven by clinical examination and at least one of the following: - Medical imaging - Endoscopic examination (examination of the digestive tract using a small camera) - Tissue examination
  • Must be able to understand and sign an informed consent form
  • Must have at least one of these conditions: - Poor response or intolerance to standard treatments (including corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate) or biological medications - Dependence on corticosteroid medications
  • Must have moderate to severe active disease shown by: - A CDAI score (measure of disease activity) between 220-450, or 200-450 for disease in the ileum area - Active inflammation of the intestine confirmed by camera examination with specific severity scores (SES-CD score of 6 or higher, or 4 or higher for ileal disease)
  • Disease must be located in one of these areas: - Ileum/ileocecal region (end part of small intestine) - Colon (large intestine) - Both ileum and colon

Who cannot join the trial?

17 criteria

  • History of severe allergic reactions or anaphylaxis to any medications
  • Current or recent (within 3 months) treatment with other biological therapies (medications made from living organisms)
  • Active or latent tuberculosis (TB) infection
  • Serious infections requiring hospitalization or IV antibiotics in the past 3 months
  • History of cancer in the past 5 years (except successfully treated non-melanoma skin cancer)
  • Severe liver disease or abnormal liver function tests
  • Severe kidney disease or significantly reduced kidney function
  • History of demyelinating disorders (conditions affecting nerve coating) like multiple sclerosis
  • Uncontrolled high blood pressure
  • Severe heart disease or heart failure
  • Pregnant or breastfeeding women
  • Active substance abuse or alcohol dependency
  • Participation in other clinical trials within the past 30 days
  • Major surgery planned during the study period
  • Current intestinal strictures (narrowing of the intestine) with obstructive symptoms
  • Active infection with hepatitis B, hepatitis C, or HIV
  • Mental health conditions that could interfere with study participation
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

AZD7798 is an investigational medication being studied for treating moderate to severe Crohn's Disease. This medication is being tested to see if it can help patients achieve remission of their Crohn's Disease symptoms. It is being compared to a placebo to determine its effectiveness and safety in controlling inflammation and reducing disease activity in patients with Crohn's Disease.

What is already known about the treatment

AZD7798 - An investigational medication being studied in clinical trials for the treatment of moderate to severe Crohn's Disease. This experimental drug is currently undergoing Phase IIa testing to evaluate its efficacy and safety in achieving disease remission, as measured by the Crohn's Disease Activity Index (CDAI). While the specific mechanism of action and administration route are not publicly disclosed in the current trial data, the drug is being tested in a double-blind, placebo-controlled study known as AMALTHEA, indicating its potential role in managing inflammatory bowel conditions. As this is an investigational compound, it is not yet approved for general medical use and is only available through clinical trials.

Investigated diseases

Crohn's Disease - A chronic inflammatory bowel disease that can affect any part of the digestive tract, from the mouth to the anus. The condition typically causes inflammation of the deep layers of the digestive tract, leading to abdominal pain, severe diarrhea, fatigue, and weight loss. The disease often develops gradually, with symptoms worsening over time, and can affect different parts of the digestive tract in different people. The inflammation can spread deep into the layers of affected bowel tissue, and healthy parts of the digestive tract can be interspersed between inflamed areas. Crohn's Disease is characterized by periods of active symptoms alternating with periods of remission.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510487-12-00Protocol codeD9690C00005Estimated enrolment193 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).