Study on the Safety and Effectiveness of AZD7798 for Adults with Ileal Crohn’s Disease and an Ileostomy

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What is this study about?

This clinical trial is focused on studying Crohn’s disease, specifically in patients who have an ileostomy. Crohn’s disease is a condition that causes inflammation in the digestive tract, and an ileostomy is a surgical opening created to allow waste to leave the body. The treatment being tested in this study is called AZD7798, which is a new medication developed to help with the repair of the lining of the intestines. The study will also use a placebo, which is a substance with no active medication, to compare the effects of AZD7798.

The purpose of this study is to evaluate how safe and well-tolerated AZD7798 is when given repeatedly over a period of time. Participants in the study will receive either AZD7798 or a placebo through an injection under the skin. The study will last for up to 52 weeks, during which participants will have regular check-ups to monitor their health and the effects of the treatment. These check-ups will include assessments like blood tests, heart monitoring using an ECG (a test that records the electrical activity of the heart), and endoscopic evaluations, which involve using a camera to look inside the intestines.

Throughout the study, researchers will closely observe any side effects and changes in the condition of the participants. The goal is to determine if AZD7798 can safely help repair the intestinal lining in people with active ileal Crohn’s disease who have an ileostomy. This research could potentially lead to new treatment options for managing Crohn’s disease in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of Crohn’s disease, and presence of an ileostomy for at least 3 months.

Active ileal Crohn’s disease is verified through a video-recorded ileoscopy during the screening period.

2 induction period

During this period, the main objective is to evaluate the safety and tolerability of repeated doses of AZD7798.

The medication is administered as a lyophilisate for solution for injection and given subcutaneously.

Participants may receive either AZD7798 or a placebo, which is a 0.9% saline solution.

3 safety and tolerability evaluations

Evaluations include monitoring for adverse events, conducting clinical laboratory assessments, measuring vital signs, and performing 12-lead ECGs.

These evaluations are conducted throughout the study, with specific assessments at week 12 and continuing to week 52.

4 endoscopic assessments

At week 12, changes from baseline in endoscopic scores are assessed to evaluate the response to treatment.

Endoscopic response is defined as a 50% decrease from baseline in the SES-CD total score, while endoscopic remission is defined as a total score less than 4 with specific criteria.

5 serum concentration and ADA response

The concentration of AZD7798 in the serum is measured.

The incidence and titre of the ADA (anti-drug antibody) response are also evaluated.

Who Can Join the Study?

Must be between 18 and 80 years old at the time of signing the informed consent form.
Must have a diagnosis of Crohn’s disease, which is confirmed through clinical tests, imaging, endoscopy (a procedure to look inside the digestive tract), or histopathologic evidence (examining tissue under a microscope).
Must have an ileostomy for at least 3 months. An ileostomy is a surgical opening made in the belly to allow waste to leave the body.
Before the screening endoscopy, there should be a clinical suspicion of active inflammation in the ileum (part of the small intestine) based on at least one of the following: a previous endoscopy, imaging tests like CT or MRI, or a fecal calprotectin (FCP) test result above the normal limit. FCP is a test that checks for inflammation in the intestines.
Must have active ileal Crohn’s disease, which means there is active inflammation in the intestinal lining. This should be shown on a video-recorded ileoscopy (a type of endoscopy focused on the ileum) done during the screening period. The inflammation should be scored by a central reader who does not know the patient’s details, with a score of 4 or more on the SES CD (a scoring system for Crohn’s disease) in the ileal segment near the stoma. Having inflammation in other parts of the intestine does not exclude participation.

Who Cannot Join the Study?

Patients who have a condition called Crohn’s Disease and have had a surgery to create an opening in the belly called an ileostomy cannot participate. An ileostomy is when part of the small intestine is brought to the surface of the belly to allow waste to leave the body.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Katholieke Universiteit te Leuven	Leuven	Belgium
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Azienda Ospedaliera di Padova	Padua	Italy
Amicare Sp. z o.o. S.K.	Lodz	Poland
Karolinska University Hospital	Solna	Sweden
Region Oestergoetland	Linkoping	Sweden
Solumed Sp. z o.o. sp.k.	Poznan	Poland
Planetmed Sp. z o.o.	Wroclaw	Poland
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.	Poznan	Poland
Ayxitciya Ubu	Amsterdam	The Netherlands
Wbd Wrngnq Iit Pjnbi Ptsozhcb Koczcfu	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	16.12.2024
Italy	Not recruiting	16.12.2024
Poland	Not recruiting	16.12.2024
Sweden	Not recruiting	16.12.2024
The Netherlands	Not recruiting	16.12.2024

Trial locations

Investigated drugs:

Azd7798

AZD7798 is a medication being studied for its potential to help repair the lining of the intestines in patients with active ileal Crohn’s Disease who have an ileostomy. The trial aims to assess how safe and tolerable this medication is when given repeatedly over a period of time.

Crohn’s Disease – Crohn’s Disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of flare-ups and remission, where symptoms can vary in intensity. During flare-ups, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The exact cause of Crohn’s Disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors. The disease can affect any part of the gastrointestinal tract from the mouth to the anus, but it most commonly affects the end of the small intestine and the beginning of the colon.

Trial ID:

2024-514407-33-00

Protocol code:

D9690C00006

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of AZD7798 for Adults with Ileal Crohn’s Disease and an Ileostomy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?