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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06450197
Registration number
NCT06450197
Ethics application status
Date submitted
8/05/2024
Date registered
10/06/2024
Date last updated
10/06/2024
Titles & IDs
Public title
Phase IIa Study Evaluating AZD7798 in Crohn's Disease
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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
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Secondary ID [1]
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D9690C00005
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Universal Trial Number (UTN)
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Trial acronym
AMALTHEA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Moderate to Severe Crohn's Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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CDAI remission
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Assessment method [1]
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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
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Endoscopic response
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Assessment method [1]
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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
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Endoscopic remission
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Assessment method [2]
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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
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Endoscopic score change from baseline
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Assessment method [3]
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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
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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CDAI response
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Assessment method [4]
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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
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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CDAI score change from baseline
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Assessment method [5]
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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
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Symptomatic remission
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Assessment method [6]
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Decrease of average daily stool frequency and average daily abdominal pain
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Timepoint [6]
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Week 12
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Secondary outcome [7]
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Serum AZD7798 concentration
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Assessment method [7]
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Serum AZD7798 concentration (PK)
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Timepoint [7]
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Up to 85 days
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Secondary outcome [8]
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Incidence of anti-drug antibody response
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Assessment method [8]
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Incidence of anti-drug antibody (ADA) response - number and percentages with a positive ADA result
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Timepoint [8]
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Up to 36 weeks
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Secondary outcome [9]
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Titre of anti-drug antibody response
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Assessment method [9]
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Titre of anti-drug antibody (ADA) response - immunogenicity titre will be summarized descriptively as a continuous variable, only for ADA positive tests
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Timepoint [9]
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Up to 36 weeks
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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.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
17/06/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
21/05/2027
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Actual
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Sample size
Target
192
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - South Brisbane
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Recruitment postcode(s) [1]
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QLD 4101 - South Brisbane
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Recruitment outside Australia
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United States of America
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Michigan
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Texas
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Buenos Aires
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Klagenfurt am Wörthersee
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Campinas
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Curitiba
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Jaú
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Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06450197
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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AstraZeneca Clinical Study Information Center
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Phone
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1-877-240-9479
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06450197
Download to PDF