Phase IIa Study Evaluating AZD7798 in Crohn's Disease (AMALTHEA)

A Double-blind, Placebo-controlled Phase IIa Study to Evaluate the Efficacy and Safety of AZD7798 in Patients With Moderate to Severe Crohn's Disease

This is a randomised, double-blind, parallel group, placebo-controlled Phase IIa study designed to evaluate the efficacy and safety of AZD7798 in participants with moderate to severe Crohn's disease.

Study Overview

• Status: Active, not recruiting
• Conditions: Moderate to Severe Crohn's Disease
• Intervention / Treatment: Other: Placebo; Drug: AZD7798

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • CABA, Argentina, C1025ABI
    • Research Site
  • CABA, Argentina, 1125
    • Research Site
  • Ciudad Autonoma de Bs As, Argentina, C1013AAB
    • Research Site
  • Ciudad de Buenos Aires, Argentina, 1128
    • Research Site
  • San Miguel de Tucumán, Argentina, 4000
    • Research Site
• Australia
  • Adelaide, Australia, 5000
    • Research Site
  • Box Hill, Australia, 3128
    • Research Site
  • Epping, Australia, 3076
    • Research Site
  • Fitzroy, Australia, 3065
    • Research Site
  • Heidelberg, Australia, 3084
    • Research Site
  • Melbourne, Australia, 3004
    • Research Site
  • Parkville, Australia, 3050
    • Research Site
  • South Brisbane, Australia, QLD 4101
    • Research Site
  • Wollongong, Australia, 2500
    • Research Site
• Belgium
  • Aalst, Belgium, 9300
    • Research Site
  • Ghent, Belgium, 9000
    • Research Site
  • Leuven, Belgium, 3000
    • Research Site
  • Liège, Belgium, 4000
    • Research Site
• Brazil
  • Campinas, Brazil, 13092133
    • Research Site
  • Jaú, Brazil, 17201-130
    • Research Site
  • Porto Alegre, Brazil, 90035-903
    • Research Site
  • Santo André, Brazil, 09080-110
    • Research Site
  • São José do Rio Preto, Brazil, 15090-000
    • Research Site
  • São Paulo, Brazil, 04543-011
    • Research Site
• Bulgaria
  • Gorna Oryahovitsa, Bulgaria, 5100
    • Research Site
  • Sofia, Bulgaria, 1784
    • Research Site
  • Sofia, Bulgaria, 1680
    • Research Site
• Canada
  • Alberta
    • Lethbridge, Alberta, Canada, T1J4G9
      • Research Site
  • Ontario
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Research Site
• Chile
  • Santiago, Chile, 8330034
    • Research Site
  • Santiago, Chile, 7500010
    • Research Site
  • Santiago, Chile, 7691236
    • Research Site
  • Viña del Mar, Chile, 2540488
    • Research Site
• China
  • Beijing, China, CN-100730
    • Research Site
  • Chengdu, China, 610041
    • Research Site
  • Guangzhou, China, 510080
    • Research Site
  • Guangzhou, China, 510655
    • Research Site
  • Hangzhou, China, 310016
    • Research Site
  • Nanchang, China, 330006
    • Research Site
  • Nanjing, China, 210029
    • Research Site
  • Wuhan, China, 430030
    • Research Site
• France
  • Amiens, France, 88054
    • Research Site
  • Lille, France, 59037
    • Research Site
  • Montpellier, France, 34090
    • Research Site
  • Pierre-Bénite, France, 69495
    • Research Site
  • Vandœuvre-lès-Nancy, France, 54500
    • Research Site
• Germany
  • Berlin, Germany, 14163
    • Research Site
  • Halle, Germany, 06108
    • Research Site
  • Jena, Germany, 07747
    • Research Site
  • Kiel, Germany, 24105
    • Research Site
  • Potsdam, Germany, 14467
    • Research Site
  • Ulm, Germany, 89081
    • Research Site
• Hungary
  • Budapest, Hungary, 1082
    • Research Site
  • Békéscsaba, Hungary, 5600
    • Research Site
  • Gyöngyös, Hungary, 3200
    • Research Site
• Italy
  • Florence, Italy, 50134
    • Research Site
  • Milan, Italy, 20132
    • Research Site
  • Milan, Italy, 20157
    • Research Site
  • Roma, Italy, 00128
    • Research Site
  • Roma, Italy, 00152
    • Research Site
  • Rome, Italy, 00168
    • Research Site
• Japan
  • Chiba, Japan, 260-8677
    • Research Site
  • Hirosaki-shi, Japan, 036-8563
    • Research Site
  • Hiroshima, Japan, 734-8551
    • Research Site
  • Kashiwa-shi, Japan, 277-0871
    • Research Site
  • Kure-shi, Japan, 737-8505
    • Research Site
  • Minatoku, Japan, 108-8642
    • Research Site
  • Morioka, Japan, 020-8505
    • Research Site
  • Nagasaki, Japan, 852-8501
    • Research Site
  • Nagoya, Japan, 466-8560
    • Research Site
  • Sakura-shi, Japan, 285-8741
    • Research Site
  • Sapporo, Japan, 060-8543
    • Research Site
  • Sendai, Japan, 980-8574
    • Research Site
• Malaysia
  • Johor Bahru, Malaysia, 80100
    • Research Site
  • Kota Bharu, Malaysia, 15586
    • Research Site
  • Kota Kinabalu, Malaysia, 88200
    • Research Site
  • Kuala Lumpur, Malaysia, 59100
    • Research Site
  • Kuching, Malaysia, 93586
    • Research Site
• Netherlands
  • Amsterdam, Netherlands, 1081 HZ
    • Research Site
  • Nijmegen, Netherlands, 6525 GA
    • Research Site
  • Tilburg, Netherlands, 5022
    • Research Site
• Poland
  • Bydgoszcz, Poland, 85-229
    • Research Site
  • Chojnice, Poland, 89-600
    • Research Site
  • Krakow, Poland, 30-363
    • Research Site
  • Lublin, Poland, 20-582
    • Research Site
  • Poznan, Poland, 60-529
    • Research Site
  • Poznan, Poland, 61-731
    • Research Site
  • Sopot, Poland, 81-756
    • Research Site
  • Warsaw, Poland, 00-189
    • Research Site
  • Warsaw, Poland, 04-501
    • Research Site
  • Wroclaw, Poland, 53-149
    • Research Site
• Romania
  • Bucharest, Romania, 011461
    • Research Site
  • Bucharest, Romania, 020125
    • Research Site
  • Bucharest, Romania, 013812
    • Research Site
  • Cluj-Napoca, Romania, 400380
    • Research Site
  • Timișoara, Romania, 300002
    • Research Site
• Slovakia
  • Košice, Slovakia, 04013
    • Research Site
  • Nitra, Slovakia, 94901
    • Research Site
  • Prešov, Slovakia, 08001
    • Research Site
  • Trnava, Slovakia, 91702
    • Research Site
• South Africa
  • Assagay, South Africa, 3610
    • Research Site
  • Plumstead, South Africa, 7800
    • Research Site
• Spain
  • Alicante, Spain, 03010
    • Research Site
  • Barcelona, Spain, 08022
    • Research Site
  • Las Palmas de Gran Canaria, Spain, 35010
    • Research Site
  • Madrid, Spain, 28046
    • Research Site
  • Seville, Spain, 41013
    • Research Site
• Sweden
  • Linköping, Sweden, 58185
    • Research Site
  • Stockholm, Sweden, 11630
    • Research Site
• Taiwan
  • New Taipei City, Taiwan, 24352
    • Research Site
  • Taichung, Taiwan, 40447
    • Research Site
  • Taipei, Taiwan, 10002
    • Research Site
  • Taoyuan, Taiwan, 333
    • Research Site
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 6500
    • Research Site
  • Ankara, Turkey (Türkiye), 06800
    • Research Site
  • Antalya, Turkey (Türkiye), 07100
    • Research Site
  • Bursa, Turkey (Türkiye), 16059
    • Research Site
  • Istanbul, Turkey (Türkiye), 34890
    • Research Site
  • Izmir, Turkey (Türkiye), 35100
    • Research Site
  • Malatya, Turkey (Türkiye), 44280
    • Research Site
  • İzmit, Turkey (Türkiye), 41000
    • Research Site
• Ukraine
  • Chernivtsі, Ukraine, 58022
    • Research Site
  • Kiev, Ukraine, 02000
    • Research Site
  • Kyiv, Ukraine, 03680
    • Research Site
  • Kyiv, Ukraine, 04210
    • Research Site
  • Ternopil, Ukraine, 46000
    • Research Site
  • Vinnytsia, Ukraine, 21009
    • Research Site
  • Vinnytsia, Ukraine, 21001
    • Research Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Research Site
  • California
    • Escondido, California, United States, 92025
      • Research Site
    • La Jolla, California, United States, 92037
      • Research Site
    • Victorville, California, United States, 92395
      • Research Site
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Research Site
  • Florida
    • Orlando, Florida, United States, 32825
      • Research Site
    • Tampa, Florida, United States, 33607
      • Research Site
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Research Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Research Site
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Research Site
  • Missouri
    • Liberty, Missouri, United States, 64068
      • Research Site
    • St Louis, Missouri, United States, 63156
      • Research Site
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Research Site
    • Charlotte, North Carolina, United States, 28204
      • Research Site
    • Winston-Salem, North Carolina, United States, 27103
      • Research Site
  • Pennsylvania
    • Uniontown, Pennsylvania, United States, 15401
      • Research Site
  • Texas
    • Dallas, Texas, United States, 75246
      • Research Site
    • Garland, Texas, United States, 75044
      • Research Site
    • Mansfield, Texas, United States, 76063
      • Research Site
    • San Antonio, Texas, United States, 78229
      • Research Site
• Vietnam
  • Hanoi, Vietnam, 10000
    • Research Site
  • Ho Chi Minh City, Vietnam, 700000
    • Research Site
  • Hà Nội, Vietnam, 100000
    • Research Site
  • Hồ Chí Minh, Vietnam, 700000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo
Experimental: AZD7798	Drug: AZD7798; AZD7798

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CDAI remission	Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. It is based on: number of loose stools, abdominal pain, general well-being, extraintestinal complications, antidiarrheal agents used in the previous 7 days, abdominal mass felt on palpation, hematocrit and body weight	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic response	Simple Endoscopic Score for Crohn's Disease (SES-CD) is based on the evaluation of five defined bowel segments (rectum, sigmoid + descending colon, transverse colon, ascending colon, and terminal ileum), and in these segments the presence and size of ulcerations and the extent of the inflammatory area and stenosis are assessed	Week 12
Endoscopic remission	Simple Endoscopic Score for Crohn's Disease (SES-CD) is based on the evaluation of five defined bowel segments (rectum, sigmoid + descending colon, transverse colon, ascending colon, and terminal ileum), and in these segments the presence and size of ulcerations and the extent of the inflammatory area and stenosis are assessed	Week 12
Endoscopic score change from baseline	Simple Endoscopic Score for Crohn's Disease (SES-CD) is based on the evaluation of five defined bowel segments (rectum, sigmoid + descending colon, transverse colon, ascending colon, and terminal ileum), and in these segments the presence and size of ulcerations and the extent of the inflammatory area and stenosis are assessed	Week 12
CDAI response	Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. It is based on: number of loose stools, abdominal pain, general well-being, extraintestinal complications, antidiarrheal agents used in the previous 7 days, abdominal mass felt on palpation, hematocrit and body weight	Week 12
CDAI score change from baseline	Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. It is based on: number of loose stools, abdominal pain, general well-being, extraintestinal complications, antidiarrheal agents used in the previous 7 days, abdominal mass felt on palpation, hematocrit and body weight	Week 12
Symptomatic remission	Decrease of average daily stool frequency and average daily abdominal pain	Week 12
Serum AZD7798 concentration	Serum AZD7798 concentration (PK)	Up to 85 days
Incidence of anti-drug antibody response	Incidence of anti-drug antibody (ADA) response - number and percentages with a positive ADA result	Up to 36 weeks
Titre of anti-drug antibody response	Titre of anti-drug antibody (ADA) response - immunogenicity titre will be summarized descriptively as a continuous variable, only for ADA positive tests	Up to 36 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 14, 2027

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; Crohn disease
• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Pathological Conditions, Signs and Symptoms; Inflammation; Crohn Disease; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: D9690C00005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No