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
1 other identifier
interventional
120
26 countries
152
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2024
152 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2024
CompletedFirst Posted
Study publicly available on registry
June 10, 2024
CompletedStudy Start
First participant enrolled
August 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2027
ExpectedApril 30, 2026
April 1, 2026
1.7 years
May 8, 2024
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Endoscopic response
Week 12
Endoscopic remission
Week 12
Endoscopic score change from baseline
Week 12
CDAI response
Week 12
CDAI score change from baseline
Week 12
- +4 more secondary outcomes
Study Arms (2)
AZD7798
EXPERIMENTALAZD7798
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- to 80 years of age.
- Diagnosis of Crohn's disease established with verifiable clinical, AND at least one of imaging, endoscopic and/or histopathologic evidence.
- Moderate to severe active Crohn's disease.
- Ileal/ileocecal (L1), colonic (L2), or ileocolonic (L3) disease, as classified based on the localisation of active inflammation.
- Capable of giving signed informed consent.
- A history of at least one of:
- Intolerance or inadequate response to conventional treatment (oral corticosteroid, azathioprine, 6-mercaptopurine, or methotrexate), biologics, or other approved advanced therapy (eg, JAK inhibitors) OR
- 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.
You may not qualify if:
- Evidence, or clinical suspicion, of other forms of IBD or concomitant additional active gastrointestinal luminal inflammatory diseases.
- Symptomatic strictures or bowel stenoses, or strictures preventing passage of endoscope throughout the colon (including at screening endoscopy).
- Any complications of Crohn's disease where surgery is anticipated or planned prior to end of study treatment.
- Evidence of extensive prior gastrointestinal surgical interventions.
- Within 3 months prior to screening endoscopy visit:
- History of toxic megacolon
- Diagnosis of peritonitis or need for treatment of peritonitis
- Bowel perforation or evidence of obstruction.
- 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.
- Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study.
- Evidence of an increased risk of colorectal cancer.
- Symptomatic oral Crohn's disease within one year.
- Any of the following treatments within the specified time period prior to screening endoscopy visit
- An anti-TNF biologic within 8 weeks prior to screening endoscopy visit
- Any biologic targeting immune response other than an anti-TNF within 12 weeks prior to screening endoscopy visit
- +30 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (152)
Research Site
Phoenix, Arizona, 85054, United States
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Escondido, California, 92025, United States
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La Jolla, California, 92037, United States
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Victorville, California, 92395, United States
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Hamden, Connecticut, 06518, United States
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Orlando, Florida, 32825, United States
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Tampa, Florida, 33607, United States
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Idaho Falls, Idaho, 83404, United States
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Kansas City, Kansas, 66160, United States
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Clinton Township, Michigan, 48038, United States
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Liberty, Missouri, 64068, United States
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St Louis, Missouri, 63156, United States
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Asheville, North Carolina, 28803, United States
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Charlotte, North Carolina, 28204, United States
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Winston-Salem, North Carolina, 27103, United States
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Uniontown, Pennsylvania, 15401, United States
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Dallas, Texas, 75246, United States
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Garland, Texas, 75044, United States
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Mansfield, Texas, 76063, United States
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San Antonio, Texas, 78229, United States
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CABA, 1125, Argentina
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CABA, C1025ABI, Argentina
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Ciudad Autonoma de Bs As, C1013AAB, Argentina
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Ciudad de Buenos Aires, 1128, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Adelaide, 5000, Australia
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Box Hill, 3128, Australia
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Epping, 3076, Australia
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Fitzroy, 3065, Australia
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Heidelberg, 3084, Australia
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Melbourne, 3004, Australia
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Parkville, 3050, Australia
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South Brisbane, QLD 4101, Australia
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Wollongong, 2500, Australia
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Aalst, 9300, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Campinas, 13092133, Brazil
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Jaú, 17201-130, Brazil
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Porto Alegre, 90035-903, Brazil
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Santo André, 09080-110, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 04543-011, Brazil
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Gorna Oryahovitsa, 5100, Bulgaria
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Sofia, 1680, Bulgaria
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Sofia, 1784, Bulgaria
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Lethbridge, Alberta, T1J4G9, Canada
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Vaughan, Ontario, L4L 4Y7, Canada
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Santiago, 7500010, Chile
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Santiago, 7691236, Chile
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Santiago, 8330034, Chile
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Viña del Mar, 2540488, Chile
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Beijing, CN-100730, China
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Chengdu, 610041, China
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Guangzhou, 510080, China
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Guangzhou, 510655, China
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Hangzhou, 310016, China
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Nanchang, 330006, China
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Nanjing, 210029, China
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Wuhan, 430030, China
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Amiens, 88054, France
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Lille, 59037, France
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Montpellier, 34090, France
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Pierre-Bénite, 69495, France
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Vandœuvre-lès-Nancy, 54500, France
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Berlin, 14163, Germany
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Halle, 06108, Germany
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Jena, 07747, Germany
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Kiel, 24105, Germany
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Potsdam, 14467, Germany
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Ulm, 89081, Germany
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Békéscsaba, 5600, Hungary
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Budapest, 1082, Hungary
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Gyöngyös, 3200, Hungary
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Florence, 50134, Italy
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Milan, 20132, Italy
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Milan, 20157, Italy
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Roma, 00128, Italy
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Roma, 00152, Italy
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Rome, 00168, Italy
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Chiba, 260-8677, Japan
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Hirosaki-shi, 036-8563, Japan
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Hiroshima, 734-8551, Japan
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Kashiwa-shi, 277-0871, Japan
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Kure-shi, 737-8505, Japan
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Minatoku, 108-8642, Japan
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Morioka, 020-8505, Japan
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Nagasaki, 852-8501, Japan
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Nagoya, 466-8560, Japan
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Sakura-shi, 285-8741, Japan
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Sapporo, 060-8543, Japan
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Sendai, 980-8574, Japan
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Johor Bahru, 80100, Malaysia
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Kota Bharu, 15586, Malaysia
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Kota Kinabalu, 88200, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuching, 93586, Malaysia
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Amsterdam, 1081 HZ, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Tilburg, 5022, Netherlands
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Bydgoszcz, 85-229, Poland
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Chojnice, 89-600, Poland
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Krakow, 30-363, Poland
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Lublin, 20-582, Poland
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Poznan, 60-529, Poland
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Poznan, 61-731, Poland
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Sopot, 81-756, Poland
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Warsaw, 00-189, Poland
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Warsaw, 04-501, Poland
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Wroclaw, 53-149, Poland
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Bucharest, 011461, Romania
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Bucharest, 013812, Romania
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Bucharest, 020125, Romania
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Cluj-Napoca, 400380, Romania
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Timișoara, 300002, Romania
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Košice, 04013, Slovakia
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Nitra, 94901, Slovakia
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Prešov, 08001, Slovakia
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Trnava, 91702, Slovakia
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Assagay, 3610, South Africa
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Plumstead, 7800, South Africa
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Alicante, 03010, Spain
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Barcelona, 08022, Spain
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Las Palmas de Gran Canaria, 35010, Spain
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Madrid, 28046, Spain
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Seville, 41013, Spain
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Linköping, 58185, Sweden
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Stockholm, 11630, Sweden
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New Taipei City, 24352, Taiwan
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Taichung, 40447, Taiwan
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Taipei, 10002, Taiwan
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Taoyuan, 333, Taiwan
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Ankara, 06800, Turkey (Türkiye)
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Ankara, 6500, Turkey (Türkiye)
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Antalya, 07100, Turkey (Türkiye)
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Bursa, 16059, Turkey (Türkiye)
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Istanbul, 34890, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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İzmit, 41000, Turkey (Türkiye)
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Malatya, 44280, Turkey (Türkiye)
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Chernivtsі, 58022, Ukraine
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Kiev, 02000, Ukraine
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Kyiv, 03680, Ukraine
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Kyiv, 04210, Ukraine
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Ternopil, 46000, Ukraine
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Vinnytsia, 21001, Ukraine
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Vinnytsia, 21009, Ukraine
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Hanoi, 10000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Hồ Chí Minh, 700000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2024
First Posted
June 10, 2024
Study Start
August 28, 2024
Primary Completion
May 1, 2026
Study Completion (Estimated)
May 14, 2027
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.