Approval Probability
TA Base Rate
Adjusted LOA
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Also known as Mongersen
GED-0301 · 2 trials · 2 indications
Clinical remission was defined as a modified Mayo score of ≤ 2, with no individual subscore \> 1, at Week 8. The MMS was based on a modification of the total Mayo score (TMS) which included the stool frequency, rectal bleeding, and endoscopic subscores of the TMS and excluded the Physician's Global Assessment (PGA) subscore, since this was a global measure that is subjective in nature. The MMS ranges from 0 to 9 points with higher scores indicating greater disease severity. The endoscopy subscores was centrally reviewed. Two-sided confidence intervals for the within-group percentage were based on the Wilson score method.
The change from baseline in the Simplified Endoscopic Activity Score for Crohn's disease (SES-CD) score at Induction Week 12.
| Arm | Type | Description |
|---|---|---|
| GED-0301 160 mg once daily (QD) | EXPERIMENTAL | Patients will receive oral GED-0301 160 mg once daily (QD)for duration of 52 week treatment. |
| GED-0301 160mg QD 12 WK | EXPERIMENTAL | GED-0301 160 mg once daily (QD) for 12 weeks |
| GED-0301 160 mg QD 8 WK | EXPERIMENTAL | GED-0301 160 mg QD for 8 weeks followed by 4 weeks of placebo |
| GED-0301 160 mg QD 4 WK | EXPERIMENTAL | GED-0301 160 mg QD for 4 weeks followed by 8 weeks of placebo |
| Name | Type | Description |
|---|---|---|
| GED-0301 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: Inclusion Criteria: * Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Subject is able to understand and voluntarily sign an informed consent form (ICF)prior...
GED-0301 was studied for the treatment of inflammatory bowel diseases, specifically ulcerative colitis and Crohn disease. Clinical development focused on patients with active disease. It is an investigational therapy and has not been approved for any indication.
GED-0301 was developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the clinical studies evaluating the drug in ulcerative colitis and Crohn disease.
GED-0301 reached Phase 2 clinical development. A Phase 2 study evaluated it in active ulcerative colitis, and a Phase 1 study evaluated it in active Crohn disease. Both studies are completed, and the drug remains investigational rather than approved.
GED-0301 was evaluated in two completed trials. NCT02601300 was a Phase 2 efficacy and safety study in active ulcerative colitis with 41 participants across the United States, Bulgaria, Canada, Hungary, Poland, and Slovakia. NCT02367183 was a Phase 1 randomized, double-blind study in active Crohn disease with 64 participants.
Yes, GED-0301 is also known as mongersen. The two names refer to the same investigational compound. The Phase 2 ulcerative colitis study was titled as a study of mongersen (GED-0301), confirming the names are used interchangeably.