Moderate to Severe Crohn's DiseasePhase 2AMALTHEANCT06450197
Phase IIa Study Evaluating AZD7798 in Crohn's Disease
A Phase 2 study testing AZD7798 in people with Moderate to Severe Crohn's Disease, run by AstraZeneca at 116 sites in 26 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Moderate to Severe Crohn's Disease
- What is being tested?
- AZD7798
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 116 sitesin 26 countries
- Study dates
- 28 Aug 2024to 14 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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.
Who cannot join
- 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
Show all 45Show fewer
- 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
- Other advanced small molecule treatments for Crohn's disease within 4 weeks prior to screening endoscopy visit
- Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or tacrolimus (FK-506) within 4 weeks prior to screening endoscopy visit
- Treatment with apheresis within 4 weeks prior to screening endoscopy visit
- Administration of any live vaccine within 4 weeks prior to screening endoscopy visit to end of study
- Faecal microbiota transplantation within 4 weeks prior to screening endoscopy visit
- Lymphocyte-depleting treatment within 12 months prior to screening endoscopy visit
- Any previous exposure to AZD7798.
- 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.
- Chronic use of nonsteroidal anti-inflammatory drugs.
- 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.
- Evidence of chronic HBV or HCV.
- History of TB (active or latent) unless an appropriate course of treatment has been completed.
- Positive diagnostic TB test at screening.
- History of serious opportunistic infection within 12 months prior to screening endoscopy visit.
- CMV colitis within previous 12 months prior to screening endoscopy visit.
- Positive C. difficile toxin stool test at screening.
- Symptomatic herpes zoster infection within 3 months prior to screening endoscopy.
- Any identified immunodeficiency.
- 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.
- Reproduction:
- Pregnant and breastfeeding patients, or those planning to breastfeed during the study
- FOCBP unless completely abstinent or using a highly effective contraception and barrier method of contraception.
- Prolonged QTcF interval.
- Clinically significant cardiovascular conditions.
- Current malignancy or history of malignancy.
- 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.
- Current enrolment in another interventional study or treatment with any investigational drug within 4 months prior to screening endoscopy visit.
- Unstable lifestyle factors.
- Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- 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
Trial locations and contacts
116 sites in 26 countries.
116 sites in 26 countries
United States13 sites
Research Site
Asheville, North Carolina, 28803
Research Site
Charlotte, North Carolina, 28204
Research Site
Clinton Township, Michigan, 48038
Research Site
Escondido, California, 92025
Research Site
Garland, Texas, 75044
Research Site
Idaho Falls, Idaho, 83404
Research Site
Kansas City, Kansas, 66160
Research Site
La Jolla, California, 92037
Research Site
Orlando, Florida, 32825
Research Site
Phoenix, Arizona, 85054
Research Site
San Antonio, Texas, 78229
Research Site
St Louis, Missouri, 63156
Research Site
Uniontown, Pennsylvania, 15401
Poland10 sites
Research Site
Bydgoszcz, 85-229
Research Site
Chojnice, 89-600
Research Site
Krakow, 30-363
Research Site
Lublin, 20-582
Research Site
Poznan, 60-529
Research Site
Poznan, 61-731
Research Site
Sopot, 81-756
Research Site
Warsaw, 00-189
Research Site
Warsaw, 04-501
Research Site
Wroclaw, 53-149
Japan9 sites
Research Site
Hiroshima, 734-8551
Research Site
Kashiwa-shi, 277-0871
Research Site
Kure-shi, 737-8505
Research Site
Minatoku, 108-8642
Research Site
Nagasaki, 852-8501
Research Site
Nagoya, 466-8560
Research Site
Sakura-shi, 285-8741
Research Site
Sapporo, 060-8543
Research Site
Sendai, 980-8574
China8 sites
Research Site
Beijing, CN-100730
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Chengdu, 610041
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Guangzhou, 510080
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Guangzhou, 510655
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Hangzhou, 310016
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Nanchang, 330006
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Nanjing, 210029
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Wuhan, 430030
Ukraine7 sites
Research Site
Chernivtsі, 58022
Research Site
Kiev, 02000
Research Site
Kyiv, 03680
Research Site
Kyiv, 04210
Research Site
Ternopil, 46000
Research Site
Vinnytsia, 21001
Research Site
Vinnytsia, 21009
Brazil6 sites
Research Site
Campinas, 13092133
Research Site
Jaú, 17201-130
Research Site
Porto Alegre, 90035-903
Research Site
Santo André, 09080-110
Research Site
São José do Rio Preto, 15090-000
Research Site
São Paulo, 04077020
Turkey (Türkiye)6 sites
Research Site
Ankara, 06800
Research Site
Ankara, 6500
Research Site
Antalya, 07100
Research Site
Izmir, 35100
Research Site
İzmit, 41000
Research Site
Malatya, 44280
Argentina5 sites
Research Site
CABA, 1125
Research Site
CABA, C1025ABI
Research Site
Ciudad Autonoma de Bs As, C1013AAB
Research Site
Ciudad de Buenos Aires, 1128
Research Site
San Miguel de Tucumán, 4000
Australia5 sites
Research Site
Adelaide, 5000
Research Site
Box Hill, 3128
Research Site
Fitzroy, 3065
Research Site
Melbourne, 3004
Research Site
Wollongong, 2500
Malaysia5 sites
Research Site
Johor Bahru, 80100
Research Site
Kota Bharu, 15586
Research Site
Kota Kinabalu, 88200
Research Site
Kuala Lumpur, 59100
Research Site
Kuching, 93586
Chile4 sites
Research Site
Santiago, 7500010
Research Site
Santiago, 7691236
Research Site
Santiago, 8330034
Research Site
Viña del Mar, 2540488
Italy4 sites
Research Site
Milan, 20132
Research Site
Milan, 20157
Research Site
Roma, 00152
Research Site
Rome, 00168
Slovakia4 sites
Research Site
Košice, 04013
Research Site
Nitra, 94901
Research Site
Prešov, 08001
Research Site
Trnava, 91702
Taiwan4 sites
Research Site
New Taipei City, 24352
Research Site
Taichung, 40447
Research Site
Taipei, 10002
Research Site
Taoyuan, 333
Vietnam4 sites
Research Site
Hà Nội, 100000
Research Site
Hanoi, 100000
Research Site
Hồ Chí Minh, 700000
Research Site
Ho Chi Minh City, 700000
Bulgaria3 sites
Research Site
Gorna Oryahovitsa, 5100
Research Site
Sofia, 1680
Research Site
Sofia, 1784
Germany3 sites
Research Site
Berlin, 14163
Research Site
Potsdam, 14467
Research Site
Ulm, 89081
Romania3 sites
Research Site
Bucharest, 020125
Research Site
Cluj-Napoca, 400380
Research Site
Timișoara, 300002
France2 sites
Research Site
Montpellier, 34090
Research Site
Pierre-Bénite, 69495
South Africa2 sites
Research Site
Assagay, 3610
Research Site
Plumstead, 7800
About this study
Official title: 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.
- Conditions
- Moderate to Severe Crohn's Disease
- Being tested
- AZD7798, Placebo
- Keywords
- Crohn disease, Inflammation
- Medical subject headings
- Crohn Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7798Drug
AZD7798
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| AZD7798 | Experimental | AZD7798 Receives: Drug: AZD7798 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 12
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 12
Symptomatic remission
Decrease of average daily stool frequency and average daily abdominal pain
Measured: Week 12
Serum AZD7798 concentration
Serum AZD7798 concentration (PK)
Measured: 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
Measured: 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
Measured: Up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start28 Aug 2024
- Primary completion30 Apr 2026
- Study completion14 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450197
- Sponsor's protocol ID
- D9690C00005
- Acronym
- AMALTHEA
- Status last verified
- Oct 2026
- First submitted
- 8 May 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06450197
- Acronym / sponsor ID
- AMALTHEA / D9690C00005
- Conditions
- Moderate to Severe Crohn's Disease
- Keywords
- Crohn disease, Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 14 May 2027 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD7798 | Experimental | Drug: AZD7798AZD7798 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 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.
Key exclusion criteria (45 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD7798AZD7798 | Drug | AZD7798 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
CDAI remission
Time frame: Week 12
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
9 secondary outcomes
Endoscopic response
Time frame: Week 12
Endoscopic remission
Time frame: Week 12
Endoscopic score change from baseline
Time frame: Week 12
CDAI response
Time frame: Week 12
CDAI score change from baseline
Time frame: Week 12
Symptomatic remission
Time frame: Week 12
Serum AZD7798 concentration
Time frame: Up to 85 days
Incidence of anti-drug antibody response
Time frame: Up to 36 weeks
Titre of anti-drug antibody response
Time frame: Up to 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Moderate to Severe Crohn's Disease
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RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
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RecruitingPhase 4
PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease
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A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
116 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD7798 in people with Moderate to Severe Crohn's Disease, run by AstraZeneca at 116 sites in 26 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 116 sites in United States, Poland, Japan, China, Ukraine and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CDAI remission (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.