The purpose of this study is to evaluate safety, tolerability, and effect on mucosal repair of AZD7798 compared with placebo in participants with active ileal Crohn's disease and an ileostomy.
This is a participant-and investigator-blind, randomized, parallel-group, placebo controlled phase II study designed to evaluate safety, tolerability, and mucosal repair with AZD7798 in participants with active ileal Crohn's disease and an ileostomy. This study will include a screening period, an induction period, an open-label maintenance period, and a follow-up period. Approximately 30 participants will be randomized globally to receive either AZD7798 or placebo during 12-week participant- and investigator- blind induction period. At week 12 after induction period, all eligible participants will enter 40-week open label maintenance period. Follow-up visits will take place 8 weeks and 18 weeks after the last dose of study intervention, whether this occurs during the induction period or the open-label maintenance period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
24
Research Site
Leuven, Belgium
Research Site
Padova, Italy
Research Site
Roma, Italy
Number of participants with adverse events
Summary of any adverse events and also by MedDRA SOC and Preferred term
Time frame: from Week 0 to Week 12
Number of participants with abnormal Vital signs: Blood pressure
Systolic and diastolic blood pressure will be summarized by descriptive statistics
Time frame: from Week 0 to Week 12
Number of participants with abnormal Vital signs: Pulse rate
Pulse rate will be summarized by descriptive statistics
Time frame: from Week 0 to Week 12
Number of participants with abnormal values in haematology: complete blood count (CBC)
The variables platelet count, red blood cell (RBC) count, haemoglobin, haematocrit will be summarized with descriptive statistics
Time frame: from Week 0 to Week 12
Number of participants with abnormal values in haematology: white blood cell (WBC) count
The variables neutrophils, lymphocytes, monocytes, eosinophils, and basophils will be summarized with descriptive statistics
Time frame: from Week 0 to Week 12
Number of participants with abnormal values in haematology: RBC
The variables mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH) and percentage of reticulocytes will be summarized with descriptive statistics
Time frame: from Week 0 to Week 12
Number of participants with abnormal values in clinical chemistry: kidney function
The variables creatinine and blood urea nitrogen (BUN) will be summarized with descriptive statistics
Time frame: from Week 0 to Week 12
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Research Site
Rozzano, Italy
Research Site
Amsterdam, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Warsaw, Poland
Research Site
Linköping, Sweden
Research Site
Stockholm, Sweden
Research Site
Kyiv, Ukraine
...and 7 more locations
Number of participants with abnormal values in clinical chemistry: electrolytes
The variables potassium, sodium, and calcium will be summarized with descriptive statistics
Time frame: from Week 0 to Week 12
Number of participants with abnormal values in clinical chemistry: liver function
The variables ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), and ALP (alkaline phosphatase), and albumin will be summarized with descriptive statistics
Time frame: from Week 0 to Week 12
Number of participants with abnormal values in clinical chemistry: hs-CRP
The variable hs-C-reactive protein will be summarized with descriptive statistics
Time frame: from Week 0 to Week 12
Number of participants with abnormal values in clinical chemistry: glucose
The variable glucose will be summarized with descriptive statistics
Time frame: from Week 0 to Week 12
Number of participants with abnormal values in ECG readings
12-lead ECGs will be obtained using an ECG machine, that automatically measures RR/HR, PR, QRS, QT and Corrected QT (QTc) intervals, and summarized with descriptive statistics
Time frame: from Week 0 to Week 12
Difference in mean change from baseline in endoscopic score between active and placebo
Simple Endoscopic Score for Crohn's Disease (SES-CD) is based on the evaluation of ileum, and the presence and size of ulcerations and the extent of the inflammatory area and stenosis are assessed. The segment is scored from 0 to 12, higher scores indicating more active disease
Time frame: Week 12
Number of participants with endoscopic response
Endoscopic response is defined as ≥ 50% decrease from baseline in SES-CD total score and based on the evaluation of ileum and the presence and size of ulcerations and the extent of the inflammatory area and stenosis are assessed. The segment is scored from 0 to 12, higher scores indicating more active disease
Time frame: Week 12
Number of participants with endoscopic remission
Endoscopic remission is defined as SES-CD total score \< 4 and at least 2 point reduction from baseline with no sub score \> 1 in any individual variable. SES-CD is based on the evaluation of ileum, and the presence and size of ulcerations and the extent of the inflammatory area and stenosis are assessed. The segment is scored from 0 to 12, higher scores indicating more active disease
Time frame: Week 12
Serum AZD7798 concentration
Serum AZD7798 concentration (PK)
Time frame: up to 52 Weeks
Incidence of anti-drug antibody response
Incidence of anti-drug antibody (ADA) response - number and percentages with a positive ADA result
Time frame: up to 52 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
Time frame: up to 52 Weeks
Number of participants with adverse events in active treatment
Summary of any adverse events and also by MedDRA SOC and Preferred term
Time frame: from Week 12 to Week 52
Number of participants with abnormal vital signs: Blood pressure
Systolic and diastolic blood pressure will be summarized by descriptive statistics
Time frame: from Week 12 to Week 52
Number of participants with abnormal vital signs: Pulse rate
Pulse rate will be summarized by descriptive statistics
Time frame: from Week 12 to Week 52
Number of participants with abnormal values in haematology: complete blood count (CBC)
The variables platelet count, red blood cell (RBC) count, haemoglobin, haematocrit will be summarized with descriptive statistics
Time frame: from Week 12 to Week 52
Number of participants with abnormal values in haematology: white blood cell (WBC) count
The variables neutrophils, lymphocytes, monocytes, eosinophils, and basophils will be summarized with descriptive statistics
Time frame: from Week 12 to Week 52
Number of participants with abnormal values in haematology: RBC
The variables mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH) and percentage of reticulocytes will be summarized with descriptive statistics
Time frame: from Week 12 to Week 52
Number of participants with abnormal values in clinical chemistry: kidney function
The variables creatinine and blood urea nitrogen (BUN) will be summarized with descriptive statistics
Time frame: from week 12 to week 52
Number of participants with abnormal values in clinical chemistry: electrolytes
The variables potassium, sodium, and calcium will be summarized with descriptive statistics
Time frame: from Week 12 to Week 52
Number of participants with abnormal values in clinical chemistry: liver function
The variables ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), and ALP (alkaline phosphatase), and albumin will be summarized with descriptive statistics
Time frame: from Week 12 to Week 52
Number of participants with abnormal values in clinical chemistry: hs-CRP
The variable hs-C-reactive protein will be summarized with descriptive statistics
Time frame: from Week 12 to Week 52
Number of participants with abnormal values in clinical chemistry: glucose
The variable glucose will be summarized with descriptive statistics
Time frame: from Week 12 to Week 52
Number of participants with abnormal values in ECG readings
12-lead ECGs will be obtained using an ECG machine, that automatically measures RR/HR, PR, QRS, QT and Corrected QT (QTc) intervals, and summarized with descriptive statistics
Time frame: from week 12 to week 52