Approval Probability
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MultiStem low dose · 1 trial · 1 indication
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...
MultiStem low dose is an investigational small molecule being studied for the treatment of moderate to severe ulcerative colitis, a form of inflammatory bowel disease. It is being evaluated for its safety and potential clinical benefit in patients with this condition.
MultiStem low dose is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research to evaluate the drug's safety and efficacy in ulcerative colitis.
MultiStem low dose is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and potential benefits in patients with moderate to severe ulcerative colitis.
MultiStem low dose has been studied in a Phase 2 clinical trial with the identifier NCT01240915. This completed, randomized, double-blind, controlled study enrolled 105 participants with moderate to severe ulcerative colitis across multiple countries, including the United States, Belgium, Canada, Germany, Hungary, Italy, Slovakia, and Sweden.
MultiStem low dose is a specific dosage form of the investigational drug MultiStem. The clinical trial NCT01240915 investigated the safety and possible clinical benefit of MultiStem in patients with moderate to severe ulcerative colitis, with the low dose being one of the doses evaluated in the study.