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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01240915 | A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis | PHASE2 | COMPLETED | 105 | — | — | Feb 1, 2011 | Nov 1, 2014 | Feb 23, 2016 | 58 | United States, Belgium +6 |
Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding).
Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.
Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
The intensity grades were defined as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | The first 9 subjects will be recruited into Cohort 1 and will receive either placebo (n=3) or MultiStem low dose (n=6) as an intravenous infusion on Day 1. The first five patients enrolled constitute a subgroup of Cohort 1 and these patients will receive multiple doses, once every day for 7 days for 3 doses (Day 1 and Weeks 1 \& 2). |
| Cohort 2 | EXPERIMENTAL | This group will receive either placebo (n=3) or MultiStem high dose (n=6) as an intravenous infusion on Day 1. The subjects then receive the opposite dose of study medication at Week 8. |
| Cohort 3 | EXPERIMENTAL | These subjects (total n=88 evaluable patients) will receive either Placebo or MultiStem (1:1 randomization) as an intravenous infusion on Day 1. In addition all subjects in Cohort 3 will receive a single infusion of either MultiStem or Placebo at Week 8, depending on their randomization schedule. A total of \~22 patients will receive an additional infusion of MultiStem, \~44 patients will receive the alternative blinded therapy to that which they received for Day 1 infusion, and \~22 patients will receive an additional infusion of placebo. |
| Name | Type | Description |
|---|---|---|
| placebo | DRUG | once every 7 days for 1- 3 doses |
| MultiStem low dose | DRUG | 1-3 doses |
| MultiStem high dose | DRUG | Single dose Day 1 |
Inclusion Criteria: * Subjects must have a documented diagnosis of ulcerative colitis at least 6 months prior to screening. * Subjects must have active moderate-to-severe ulcerative colitis based on Mayo score. * Subjects must have Modified Baron endoscopic score of at least 2 determined within 7 d...