Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Study Drug
AZD7798 · 5 trials · 5 indications
Summary of any adverse events and also by MedDRA SOC and Preferred term
Systolic and diastolic blood pressure will be summarized by descriptive statistics
Pulse rate will be summarized by descriptive statistics
The variables platelet count, red blood cell (RBC) count, haemoglobin, haematocrit will be summarized with descriptive statistics
The variables neutrophils, lymphocytes, monocytes, eosinophils, and basophils will be summarized with descriptive statistics
The variables mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH) and percentage of reticulocytes will be summarized with descriptive statistics
The variables creatinine and blood urea nitrogen (BUN) will be summarized with descriptive statistics
The variables potassium, sodium, and calcium will be summarized with descriptive statistics
The variables ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), and ALP (alkaline phosphatase), and albumin will be summarized with descriptive statistics
The variable hs-C-reactive protein will be summarized with descriptive statistics
The variable glucose will be summarized with descriptive statistics
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
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
Standardized uptake value (SUV) is the radioactivity concentration in given region of interest normalized for injected radioactivity and body weight. Standardised uptake value ratio (SUVR) is the ratio of SUV in a given region of interest to a reference region without significant radioligand uptake
Kp is the partition coefficient that denotes radioactivity concentration ratio (area under the concentration-time curve \[AUC\] 0-60 min, intestines/AUC 0-60 min, blood). Kp denotes that denominator is the radioactivity measurement in blood (aorta), this is the reference region used in calculations. Percentage change in small bowel Kp from baseline (PET1 Visit) to PET2 visit is reported.
Kp is the partition coefficient that denotes radioactivity concentration ratio (area under the concentration-time curve \[AUC\] 0-60 min, intestines/AUC 0-60 min, blood). Kp denotes that denominator is the radioactivity measurement in blood (aorta), this is the reference region used in calculations. Percentage change in small bowel Kp from baseline (PET1 Visit) to PET3 visit is reported.
The safety and tolerability of AZD7798 following administration of single ascending doses will be assessed.
| Arm | Type | Description |
|---|---|---|
| AZD7798 | EXPERIMENTAL | AZD7798 |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Panel 1 | EXPERIMENTAL | Healthy participants will receive a single IV bolus dose of radioligand \[11\^C\]AZ14132516 between Day -7 to Day -1 followed by a single IV infusion of AZD7798 Dose Level 1 on Day 1. Thereafter, again will receive IV bolus dose of radioligand \[11\^C\]AZ14132516 on Day 14 and Day 42. |
| Panel 2 | EXPERIMENTAL | Healthy participants will receive a single IV bolus dose of radioligand \[11\^C\]AZ14132516 between Day -7 to Day -1 followed by a single IV infusion of AZD7798 Dose Level 2 on Day 1. Thereafter, again will receive IV bolus dose of radioligand \[11\^C\]AZ14132516 on Day 14 and Day 56. |
| Panel 3 | EXPERIMENTAL | Healthy participants will receive a single IV bolus dose of radioligand \[11\^C\]AZ14132516 between Day -7 to Day -1 followed by a single IV infusion of AZD7798 Dose Level 2 on Day 1. Thereafter, again will receive IV bolus dose of radioligand \[11\^C\]AZ14132516 on Day 2 and Day 42. |
| Panel 4 | EXPERIMENTAL | Participants with Crohn's disease will receive a single IV bolus dose of radioligand \[11\^C\]AZ14132516 between Day -7 to Day -1 followed by a single IV infusion of AZD7798 Dose Level 1 on Day 1. Thereafter, again will receive IV bolus dose of radioligand \[11\^C\]AZ14132516 on Day 14 and Day 42. |
| Panel 5 | EXPERIMENTAL | Participants with Crohn's disease will receive a single IV bolus dose of radioligand \[11\^C\]AZ14132516 between Day -7 to Day -1 followed by a single IV infusion of AZD7798 Dose Level 2 on Day 1. Thereafter, again will receive IV bolus dose of radioligand \[11\^C\]AZ14132516 on Day 14 and Day 42. |
| Panel 6 | EXPERIMENTAL | Participants with Crohn's disease will receive a single IV bolus dose of radioligand \[11\^C\]AZ14132516 between Day -7 to Day -1 followed by IV infusion of AZD7798 Dose Level 1 on Day 1 (Dose 1) and Day 15 (Dose 2). Thereafter, again will receive IV bolus dose of radioligand \[11\^C\]AZ14132516 on Day 14 and Day 28. |
| Part 1a - Cohort 1: AZD7798 dose 1 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 2: AZD7798 dose 2 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 3: AZD7798 dose 3 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 4: AZD7798 dose 4 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 5: AZD7798 dose 5 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 6: AZD7798 dose 6 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 7: AZD7798 dose 7 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1b - Cohort 8: AZD7798 dose 8 | EXPERIMENTAL | A total of 6 subjects will receive repeat doses of AZD7798. |
| Part 1a - Spare Cohort 9: AZD7798 dose 9 | EXPERIMENTAL | A total of 6 subjects will receive a single ascending dose of AZD7798. |
| Part 2 - Cohort 10: AZD7798 + AZD7798 | EXPERIMENTAL | A total of 4 subjects will receive a single dose on Day 1 followed by a single dose on Day 15. |
| Part 2 - Cohort 11: Placebo + AZD7798 | EXPERIMENTAL | A total of 2 subjects will receive placebo on day 1 followed by AZD7798 on day 15. |
| Part 2 - Cohort 12: AZD7798 + Placebo | EXPERIMENTAL | A total of 2 subjects will receive AZD7798 on day 1 followed by placebo on day 15. |
| Placebo: Part 1a and Part 1b | EXPERIMENTAL | A total of 2 subjects per cohort will receive placebo. |
| Part 3a - Cohort 12: AZD7798 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 3b - Cohort 13: AZD7798 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Placebo: Part 3a and Part 3b | EXPERIMENTAL | A total of 2 subjects per cohort will receive placebo. |
| Name | Type | Description |
|---|---|---|
| AZD7798 | DRUG | AZD7798 |
| Placebo | OTHER | Placebo |
| [11C]AZ14132516 | DRUG | A single microdose (≤ 10 μg) of radiopharmaceutical \[11C\]AZ14132516 will be extemporaneously prepared and administered to each participant prior to each PET examination |
Inclusion Criteria: * 18 to 80 years of age. * Diagnosis of Crohn's disease established with clinical AND at least one of imaging, endoscopic, and/or histopathologic evidence. * Ileostomy (including Kock pouch) for at least 3 months. * Prior to screening endoscopy, clinical suspicion of active ilea...
Top 15 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Duvakitug, balinatunfib, Brivekimig |
| AbbVie, Inc. | ABBV | 16 | PHASE3 | Upadacitinib, Risankizumab, Lutikizumab, Trosunilimab, ABBV-8736 |
| Eli Lilly and Company | LLY | 7 | PHASE3 | Mirikizumab, Tirzepatide, LY4395089, MORF-057 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 15 | PHASE3 | Vedolizumab, Zasocitinib, Darvadstrocel |
| Johnson & Johnson | JNJ | 24 | PHASE3 | Ustekinumab, Guselkumab, JNJ-78934804, Golimumab, Icotrokinra |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Spyre Therapeutics, Inc | SYRE | 2 | PHASE2 | SPY001, SPY002, SPY003 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Shattuck Labs, Inc. | STTK | 1 | PHASE2 | SL-325 |
| AgomAb Therapeutics NV ADR | AGMB | 2 | PHASE2 | Ontunisertib |
| Hoffmann-La Roche | RHHBY | 1 | PHASE2 | Afimkibart |
| Pfizer Inc. | PFE | 1 | PHASE2 | Etrasimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
AZD7798 is an investigational small molecule being developed for the treatment of Crohn disease, including moderate to severe Crohn disease. It is a gastrointestinal therapy and is not yet approved for commercial use. AstraZeneca is studying it in adults aged 18 and older, including patients with an ileostomy.
AZD7798 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is running the clinical program for the drug across multiple countries, including the United States, Canada, and several European and Asian nations.
AZD7798 is in Phase 2 clinical development for Crohn disease. Two Phase 2 trials are currently active but not recruiting, and two earlier Phase 1 positron emission tomography studies have been completed. The drug remains investigational and has not been approved by the FDA.
AZD7798 has been studied in four clinical trials. The Phase 2a study NCT06450197 enrolled 120 patients with moderate to severe Crohn disease, and NCT06681324 is a Phase 2 study in Crohn disease patients with an ileostomy. Completed Phase 1 PET studies include NCT06432764 and NCT06053424.
Across the four listed trials, 158 participants have been enrolled in studies of AZD7798. The largest is the Phase 2a trial NCT06450197 with 120 patients, followed by NCT06681324 with 24, and the two completed Phase 1 PET studies with 13 and 9 participants respectively.
Yes, the AZD7798 clinical program includes randomized, double-blind, placebo-controlled trials. This design is used to compare the investigational small molecule against placebo in patients with Crohn disease, including moderate to severe cases, without biomarker-based patient selection.