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

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What is this study about?

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.

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 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 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 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 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 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Endomed s.r.o. Kosice Slovakia
KBC Zagreb Zagreb Croatia
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
ASST Fatebenefratelli Sacco Milan Italy
Region Oestergoetland Linkoping Sweden
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Klinikum Ernst von Bergmann gGmbH Potsdam Germany
Elias University Emergency Hospital Bucharest Romania
San Camillo Forlanini Hospital Rome Italy
Krankenhaus Waldfriede e.V. Berlin Germany
Fakultna Nemocnica Trnava Trnava Slovakia
Promed P.Lach R.Glowacki Sp. j. Cracow Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Eb Group Sp. z o.o. Warsaw Poland
Solumed Sp. z o.o. sp.k. Poznan Poland
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD Sofia Bulgaria
Endoskopia Sp. z o.o. Sopot Poland
Planetmed Sp. z o.o. Wroclaw Poland
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD Gorna Oryahovitsa Bulgaria
Poliklinika Borzan d.o.o. Osijek Croatia
Landeskrankenanstalten-Betriebsgesellschaft Kabeg Klagenfurt am Wörthersee Austria
Ospedale San Raffaele S.r.l. Milan Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
KM Management spol. s r.o. Nitra Slovakia
Medrise Sp. z o.o. Lublin Poland
Centro Medico Teknon-Grupo Quironsalud Barcelona Spain
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Virgen del Rocío University Hospital Sevilla Spain
Universita’ Campus Bio-medico Di Roma Rome Italy
Cabinet Particular Policlinic Algomed S.R.L. Timisoara Romania
Gastro LM s.r.o. Presov Slovakia
Melita Medical sp. z o.o. Wroclaw Poland
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
Centrum Medyczne Lukamed Joanna Luka Chojnice Poland
Vgvbkdow &swio Vbqmdhl Snd z oqsw Wroclaw Poland
Gjwqpl Mvf Sygfpo Cluj Napoca Romania
&caqcqsafpspgczj Ugv Ahellcevxq Mslqnse Cqmijnh &utuvpf Amsterdam The Netherlands
Egzmd Spfbspsgjtkxw Hnskcgbe Stockholm Sweden
Ojvmqcvrpwutwjcvnetthyrpiy Aalst Belgium
Sdi Eqiktukms Hkivcges Tkygude Tilburg The Netherlands
Clzv De Naocd Vandoeuvre Les Nancy France
Meraramr Ss z oatk Bydgoszcz Poland
Shysxznqt Rlgiito Uyltvlvdgg Mpmywbf Cuobig Nijmegen The Netherlands
Fmqxsbiaj Pgrb Lp Iocozfkwoytyd Bcegbqebo Dvb Htnsxsqn Ujxkhyubwbyzv La Pou Madrid Spain
Gywepi Ufyffqqczu Fzebhhshx Frankfurt Germany
Woy Wboouz Irk Pxtho Puqarpsh Kylecfg Warsaw Poland
Cmlrqhtz Hqjouacv Dkjremn Zagreb Croatia
Skbjtowkbomgkefwjbw Bhe Uj (mrwghiobfsowaawkpwtc Halle (Saale) Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
17.06.2024
Belgium Belgium
Not recruiting
17.06.2024
Bulgaria Bulgaria
Not recruiting
17.06.2024
Croatia Croatia
Not recruiting
17.06.2024
France France
Not recruiting
17.06.2024
Germany Germany
Not recruiting
17.06.2024
Hungary Hungary
Not recruiting
17.06.2024
Italy Italy
Not recruiting
17.06.2024
Poland Poland
Not recruiting
17.06.2024
Romania Romania
Not recruiting
17.06.2024
Slovakia Slovakia
Not recruiting
17.06.2024
Spain Spain
Not recruiting
17.06.2024
Sweden Sweden
Not recruiting
17.06.2024
The Netherlands The Netherlands
Not recruiting
17.06.2024

Trial locations

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.

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 ID:
2023-510487-12-00
Protocol code:
D9690C00005
NCT ID:
NCT06450197
Trial Phase:
Therapeutic exploratory (Phase II)

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