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New drug shows promise for Crohn's sufferers in Mid-Stage trial

NCT ID NCT06450197

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 9 times

Summary

This study tests a new drug called AZD7798 in 120 people with moderate to severe Crohn's disease. The goal is to see if it can reduce symptoms and improve the appearance of the gut lining. Participants are randomly assigned to receive either the drug or a placebo, and neither they nor their doctors know which they get. The trial is currently active but not recruiting new participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

120 people

The number who actually took part.

Started

Aug 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 18 to 80 years of age. 2. Diagnosis of Crohn's disease established with verifiable clinical, AND at least one of imaging, endoscopic and/or histopathologic evidence. 3. Moderate to severe active Crohn's disease. 4. Ileal/ileocecal (L1), colonic (L2), or ileocolonic (L3) disease, as classified based on the localisation of active inflammation. 5. Capable of giving signed informed consent. 6. A history of at least one of: 1. Intolerance or inadequate response to conventional treatment (oral corticosteroid, azathioprine, 6-mercaptopurine, or methotrexate), biologics, or other approved advanced therapy (eg, JAK inhibitors) OR 2. Corticosteroid dependency (defined as inability to taper below budesonide 6 mg/day or prednisolone 10 mg/day equivalent dosing without recurrent active disease) for the treatment of Crohn's disease. Exclusion Criteria: 1. Evidence, or clinical suspicion, of other forms of IBD or concomitant additional active gastrointestinal luminal inflammatory diseases. 2. Symptomatic strictures or bowel stenoses, or strictures preventing passage of endoscope throughout the colon (including at screening endoscopy). 3. Any complications of Crohn's disease where surgery is anticipated or planned prior to end of study treatment. 4. Evidence of extensive prior gastrointestinal surgical interventions. 5. Within 3 months prior to screening endoscopy visit: 1. History of toxic megacolon 2. Diagnosis of peritonitis or need for treatment of peritonitis 3. Bowel perforation or evidence of obstruction. 6. All intrabdominal abscesses are excluded. Cutaneous and perianal/perirectal abscesses and fistulae are excluded unless adequately drained at least 4 weeks prior to screening endoscopy visit with no anticipation for surgery prior to end of study treatment. 7. Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study. 8. Evidence of an increased risk of colorectal cancer. 9. Symptomatic oral Crohn's disease within one year. 10. Any of the following treatments within the specified time period prior to screening endoscopy visit 1. An anti-TNF biologic within 8 weeks prior to screening endoscopy visit 2. Any biologic targeting immune response other than an anti-TNF within 12 weeks prior to screening endoscopy visit 3. Other advanced small molecule treatments for Crohn's disease within 4 weeks prior to screening endoscopy visit 4. Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or tacrolimus (FK-506) within 4 weeks prior to screening endoscopy visit 5. Treatment with apheresis within 4 weeks prior to screening endoscopy visit 6. Administration of any live vaccine within 4 weeks prior to screening endoscopy visit to end of study 7. Faecal microbiota transplantation within 4 weeks prior to screening endoscopy visit 8. Lymphocyte-depleting treatment within 12 months prior to screening endoscopy visit 9. Any previous exposure to AZD7798. 11. Any initiation or changes in dosing of the following medications prior to screening endoscopy visit as outlined: (a) 5-aminosalicylates within 2 weeks (b) Oral corticosteroids within 2 weeks or stable doses of steroids exceeding the following dose equivalents: (i) Systemic steroids \> 20 mg/day or prednisolone equivalent (ii) Steroids with limited systemic effects (eg, budesonide and beclomethasone), exceeding maximum budesonide dose equivalent (9 mg/day) (c) Immunomodulators within 4 weeks (d) Antibiotic therapy for the treatment of Crohn's disease (e) Probiotics within 2 weeks. 12. Chronic use of nonsteroidal anti-inflammatory drugs. 13. Evidence of recent or currently active infection, including use of IV or oral antibiotics for documented infection within 30 days prior to screening endoscopy visit. 14. Evidence of chronic HBV or HCV. 15. History of TB (active or latent) unless an appropriate course of treatment has been completed. 16. Positive diagnostic TB test at screening. 17. History of serious opportunistic infection within 12 months prior to screening endoscopy visit. 18. CMV colitis within previous 12 months prior to screening endoscopy visit. 19. Positive C. difficile toxin stool test at screening. 20. Symptomatic herpes zoster infection within 3 months prior to screening endoscopy. 21. Any identified immunodeficiency. 22. Abnormal laboratory results at screening suggesting participation may be unsafe, which will prevent the patient from completing the study, or will interfere with the interpretation of the study results. 23. Reproduction: 1. Pregnant and breastfeeding patients, or those planning to breastfeed during the study 2. FOCBP unless completely abstinent or using a highly effective contraception and barrier method of contraception. 24. Prolonged QTcF interval. 25. Clinically significant cardiovascular conditions. 26. Current malignancy or history of malignancy. 27. Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, haematological disease, hepatic disease, renal disease, gastrointestinal disease or other major disease other than active Crohn's disease. 28. Current enrolment in another interventional study or treatment with any investigational drug within 4 months prior to screening endoscopy visit. 29. Unstable lifestyle factors. 30. Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 31. Investigator concerns regarding patient's willingness and ability to attend all study visits, comply with the study procedures, read in order to complete questionnaires, or to complete the study period

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Conditions

The condition(s) this trial relates to.

Crohn disease Inflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Moderate to severe Crohn's disease

Contacts and locations

Locations

  • Research Site

    Phoenix, Arizona, 85054, United States

  • Research Site

    Escondido, California, 92025, United States

  • Research Site

    La Jolla, California, 92037, United States

  • Research Site

    Orlando, Florida, 32825, United States

  • Research Site

    Idaho Falls, Idaho, 83404, United States

  • Research Site

    Kansas City, Kansas, 66160, United States

  • Research Site

    Clinton Township, Michigan, 48038, United States

  • Research Site

    St Louis, Missouri, 63156, United States

  • Research Site

    Asheville, North Carolina, 28803, United States

  • Research Site

    Charlotte, North Carolina, 28204, United States

  • Research Site

    Uniontown, Pennsylvania, 15401, United States

  • Research Site

    Garland, Texas, 75044, United States

  • Research Site

    San Antonio, Texas, 78229, United States

  • Research Site

    CABA, 1125, Argentina

  • Research Site

    CABA, C1025ABI, Argentina

  • Research Site

    Ciudad Autonoma de Bs As, C1013AAB, Argentina

  • Research Site

    Ciudad de Buenos Aires, 1128, Argentina

  • Research Site

    San Miguel de Tucumán, 4000, Argentina

  • Research Site

    Adelaide, 5000, Australia

  • Research Site

    Box Hill, 3128, Australia

  • Research Site

    Fitzroy, 3065, Australia

  • Research Site

    Melbourne, 3004, Australia

  • Research Site

    Wollongong, 2500, Australia

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Campinas, 13092133, Brazil

  • Research Site

    Jaú, 17201-130, Brazil

  • Research Site

    Porto Alegre, 90035-903, Brazil

  • Research Site

    Santo André, 09080-110, Brazil

  • Research Site

    São José do Rio Preto, 15090-000, Brazil

  • Research Site

    São Paulo, 04077020, Brazil

  • Research Site

    Gorna Oryahovitsa, 5100, Bulgaria

  • Research Site

    Sofia, 1680, Bulgaria

  • Research Site

    Sofia, 1784, Bulgaria

  • Research Site

    Lethbridge, Alberta, T1J4G9, Canada

  • Research Site

    Santiago, 7500010, Chile

  • Research Site

    Santiago, 7691236, Chile

  • Research Site

    Santiago, 8330034, Chile

  • Research Site

    Viña del Mar, 2540488, Chile

  • Research Site

    Beijing, CN-100730, China

  • Research Site

    Chengdu, 610041, China

  • Research Site

    Guangzhou, 510080, China

  • Research Site

    Guangzhou, 510655, China

  • Research Site

    Hangzhou, 310016, China

  • Research Site

    Nanchang, 330006, China

  • Research Site

    Nanjing, 210029, China

  • Research Site

    Wuhan, 430030, China

  • Research Site

    Montpellier, 34090, France

  • Research Site

    Pierre-Bénite, 69495, France

  • Research Site

    Berlin, 14163, Germany

  • Research Site

    Potsdam, 14467, Germany

  • Research Site

    Ulm, 89081, Germany

  • Research Site

    Békéscsaba, 5600, Hungary

  • Research Site

    Gyöngyös, 3200, Hungary

  • Research Site

    Milan, 20132, Italy

  • Research Site

    Milan, 20157, Italy

  • Research Site

    Roma, 00152, Italy

  • Research Site

    Rome, 00168, Italy

  • Research Site

    Hiroshima, 734-8551, Japan

  • Research Site

    Kashiwa-shi, 277-0871, Japan

  • Research Site

    Kure-shi, 737-8505, Japan

  • Research Site

    Minatoku, 108-8642, Japan

  • Research Site

    Nagasaki, 852-8501, Japan

  • Research Site

    Nagoya, 466-8560, Japan

  • Research Site

    Sakura-shi, 285-8741, Japan

  • Research Site

    Sapporo, 060-8543, Japan

  • Research Site

    Sendai, 980-8574, Japan

  • Research Site

    Johor Bahru, 80100, Malaysia

  • Research Site

    Kota Bharu, 15586, Malaysia

  • Research Site

    Kota Kinabalu, 88200, Malaysia

  • Research Site

    Kuala Lumpur, 59100, Malaysia

  • Research Site

    Kuching, 93586, Malaysia

  • Research Site

    Amsterdam, 1081 HZ, Netherlands

  • Research Site

    Bydgoszcz, 85-229, Poland

  • Research Site

    Chojnice, 89-600, Poland

  • Research Site

    Krakow, 30-363, Poland

  • Research Site

    Lublin, 20-582, Poland

  • Research Site

    Poznan, 60-529, Poland

  • Research Site

    Poznan, 61-731, Poland

  • Research Site

    Sopot, 81-756, Poland

  • Research Site

    Warsaw, 00-189, Poland

  • Research Site

    Warsaw, 04-501, Poland

  • Research Site

    Wroclaw, 53-149, Poland

  • Research Site

    Bucharest, 020125, Romania

  • Research Site

    Cluj-Napoca, 400380, Romania

  • Research Site

    Timișoara, 300002, Romania

  • Research Site

    Košice, 04013, Slovakia

  • Research Site

    Nitra, 94901, Slovakia

  • Research Site

    Prešov, 08001, Slovakia

  • Research Site

    Trnava, 91702, Slovakia

  • Research Site

    Assagay, 3610, South Africa

  • Research Site

    Plumstead, 7800, South Africa

  • Research Site

    Barcelona, 08022, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Linköping, 58185, Sweden

  • Research Site

    Stockholm, 11630, Sweden

  • Research Site

    New Taipei City, 24352, Taiwan

  • Research Site

    Taichung, 40447, Taiwan

  • Research Site

    Taipei, 10002, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Ankara, 06800, Turkey (Türkiye)

  • Research Site

    Ankara, 6500, Turkey (Türkiye)

  • Research Site

    Antalya, 07100, Turkey (Türkiye)

  • Research Site

    Izmir, 35100, Turkey (Türkiye)

  • Research Site

    İzmit, 41000, Turkey (Türkiye)

  • Research Site

    Malatya, 44280, Turkey (Türkiye)

  • Research Site

    Chernivtsі, 58022, Ukraine

  • Research Site

    Kiev, 02000, Ukraine

  • Research Site

    Kyiv, 03680, Ukraine

  • Research Site

    Kyiv, 04210, Ukraine

  • Research Site

    Ternopil, 46000, Ukraine

  • Research Site

    Vinnytsia, 21001, Ukraine

  • Research Site

    Vinnytsia, 21009, Ukraine

  • Research Site

    Hanoi, 100000, Vietnam

  • Research Site

    Hà Nội, 100000, Vietnam

  • Research Site

    Ho Chi Minh City, 700000, Vietnam

  • Research Site

    Hồ Chí Minh, 700000, Vietnam

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