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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06450197




Registration number
NCT06450197
Ethics application status
Date submitted
8/05/2024
Date registered
10/06/2024
Date last updated
20/11/2024

Titles & IDs
Public title
Phase IIa Study Evaluating AZD7798 in Crohn's Disease
Scientific 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
Secondary ID [1] 0 0
D9690C00005
Universal Trial Number (UTN)
Trial acronym
AMALTHEA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to Severe Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD7798
Other interventions - Placebo

Experimental: AZD7798 - AZD7798

Placebo comparator: Placebo - Placebo


Treatment: Drugs: AZD7798
AZD7798

Other interventions: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
CDAI remission
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Endoscopic response
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Endoscopic remission
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Endoscopic score change from baseline
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
CDAI response
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
CDAI score change from baseline
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Symptomatic remission
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Serum AZD7798 concentration
Timepoint [7] 0 0
Up to 85 days
Secondary outcome [8] 0 0
Incidence of anti-drug antibody response
Timepoint [8] 0 0
Up to 36 weeks
Secondary outcome [9] 0 0
Titre of anti-drug antibody response
Timepoint [9] 0 0
Up to 36 weeks

Eligibility
Key inclusion criteria
1. 18 to 80 years of age.
2. Diagnosis of Crohn's disease established with verifiable clinical, 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 without recurrent active disease) for the treatment of Crohn's disease.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Evidence, or clinical suspicion, of other forms of IBD or concomitant additional active gastrointestinal luminal inflammatory diseases.
2. Known symptomatic strictures or bowel stenoses or strictures preventing passage of endoscope throughout the colon.
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. Undrained fistula or abscess, including intrabdominal abscesses.
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 changes in dosing of the following medications prior to screening endoscopy visit as outlined:

1. 5-aminosalicylates within 2 weeks
2. Oral corticosteroids within 2 weeks:

(i) Prednisolone (ii) Budesonide (c) Immunomodulators within 4 weeks (d) Antibiotic therapy for the treatment of Crohn's disease (e) Probiotics within 2 weeks.
12. Known or suspected history of 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/05/2027
Actual
Sample size
Target
192
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Bedford Park
Recruitment hospital [3] 0 0
Research Site - Box Hill
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Research Site - Epping
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Research Site - Fitzroy
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Research Site - Heidelberg
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Research Site - Liverpool
Recruitment hospital [8] 0 0
Research Site - Melbourne
Recruitment hospital [9] 0 0
Research Site - Parkville
Recruitment hospital [10] 0 0
Research Site - South Brisbane
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3076 - Epping
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
2170 - Liverpool
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
QLD 4101 - South Brisbane
Recruitment outside Australia
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United States of America
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Quilmes
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Klagenfurt
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Bucuresti
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Cluj Napoca
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Kosice
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Nitra
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Presov
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Plumstead
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Barcelona
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Las Palmas de Gran Canaria
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Madrid
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Sevilla
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Sweden
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Stockholm
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Taiwan
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Kaohsiung
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New Taipei City
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Taipei
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Taiwan
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Taoyuan
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Turkey
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Ankara
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Antalya
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Turkey
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Bursa
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Istanbul
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Izmir
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Izmit
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Turkey
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Malatya
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Ukraine
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Chernivts?
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Ukraine
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Kiev
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Ukraine
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Kyiv
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Ternopil
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Vinnytsia
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Vietnam
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Hanoi
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Vietnam
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Ho Chi Minh city
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Vietnam
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT06450197
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06450197