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.
1Initial 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).
2Treatment 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.
3Treatment 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.
4Monitoring 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.
5Study 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 Study?
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 Study?
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
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.
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.
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