Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04681066 | A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS | PHASE2 | COMPLETED | 216 | — | — | Mar 24, 2021 | May 15, 2024 | Oct 16, 2025 | 37 | United States, India |
Time to Solid Food Tolerance (TSFT): Number of hours from date/time of SFISD to date/time patient receives a solid meal that is tolerated, defined as eating \>/=50% of a low fat \>/= 500-calorie solid meal w/o increase in abdominal pain or vomiting within 2 hours of mealtime. If patient was discharged w/o tolerating solid food, the daily record of the modified ANMS Gastrointestinal Cardinal Symptom Index Daily Diary (mGCSI-DD) at or after hospital discharge was used to calculate TSFT. For these patients, TSFT date/time was considered to be 8am on the first of 3 consecutive days where the following criteria were met in mGCSI-DD: no vomiting, no or mild nausea, no or mild inability to finish a normal sized meal, no or mild abdominal pain. gMCP-Mod: Generalized Multiple Comparisons and Modeling--3 steps: 1) Hazard ratio (dose vs placebo) using stratified Cox regression w/ stratification by sex and hematocrit (high/low). 2) Multiple contrast test. 3) Find best-fit dose-response model.
| Arm | Type | Description |
|---|---|---|
| 2.0 mg/kg (1.25 mL/kg) | ACTIVE_COMPARATOR | administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses. |
| 1.0 mg/kg (0.625 mL/kg) | ACTIVE_COMPARATOR | administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses. |
| 0.5 mg/kg (0.3125 mL/kg) | ACTIVE_COMPARATOR | administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses. |
| Placebo (1.25, 0.625, or 0.3125 mL/kg) | PLACEBO_COMPARATOR | patients randomized to placebo will receive one of three following volumes (1.25 mL/kg, 0.625 mL/kg, and 0.3125 mL/kg. although three volumes - all patients randomized to placebo will be analyzed together as one arm. administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses. |
| Name | Type | Description |
|---|---|---|
| CM-4620 Injectable Emulsion or CM-4620-IE | DRUG | Auxora is to be administered as an IV infusion and is supplied as a translucent, white to yellowish colored, sterile, non-pyrogenic emulsion containing 1.6 mg/mL of the active pharmaceutical ingredient CM4620. CM4620-IE is supplied as an 80 mL fill in a 100 mL, single-use glass vial. The drug product is formulated as an emulsion due to the low solubility of CM4620 in aqueous solution. CM4620-IE contains egg phospholipids, medium chain triglycerides, glycerin, edetate disodium salt dehydrate (EDTA), sodium hydroxide (as needed to adjust pH), and sterile water for injection. |
| Placebo | OTHER | Matching Placebo is to be administered as an IV infusion and is supplied as a translucent, white to yellowish, sterile, non-pyrogenic emulsion carrier containing no active pharmaceutical ingredient. Placebo is supplied as an 80 mL fill in a 100 mL single-use vial. Placebo contains the same ingredients as Auxora except that it does not contain CM4620. |
Inclusion Criteria: All of the following must be met for a patient to be randomized into the study: 1. The diagnosis of acute pancreatitis has been established by the presence of abdominal pain consistent with acute pancreatitis together with at least 1 of the following 2 criteria: 1. Serum li...