Drugs / MONGERSEN SODIUM
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02957474 | Nov → Dec 2016 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02367183 | Apr 2015 → Sep 2016 | Crohn disease | Celgene Corporation | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02685683 | Apr 2016 → Sep 2017 | Crohn disease | Celgene Corporation | Terminated | No outcome recorded |
| Phase 2 | NCT02601300 | Dec 2015 → Sep 2016 | ulcerative colitis | Celgene Corporation | Completed | No outcome recorded |
| Phase 33 trials · 1 missed | ||||||
| Phase 3 | NCT02974322 | Dec 2017 → Nov 2018 | Crohn disease | Celgene Corporation | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT02641392 | Jul 2016 → Jan 2018 | Crohn disease | Celgene Corporation | Terminated | No outcome recorded |
| Phase 3 | NCT02596893 | Dec 2015 → Jan 2018 | Crohn disease | Celgene Corporation | Terminated | Missed primary |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MONGERSEN SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707383 ↗ |
| Known as | GED-0301 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02685683 ↗ |
| Known as | GED-0301 SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707383 ↗ |
| Known as | Mongersen | “The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease.” NCT02974322 ↗3“Effects of Mongersen (GED-0301) on Endoscopic and Clinical Outcomes in Patients With Active Crohn's Disease.” PMID 28847751 ↗ Aug 2017 “An Efficacy and Safety Study of Mongersen (GED-0301) in Subjects With Active Ulcerative Colitis” NCT02601300 ↗ “Mongersen (GED-0301) for Active Crohn's Disease: Results of a Phase 3 Study.” PMID 31850931 ↗ May 2020 |
| Action | Inhibit | “The batch of Mongersen used in this study, but not two batches used in the phase III study, inhibited Smad7 expression in HCT-116 cells.” PMID 33871807 ↗ Apr 2021 |
| Modality | Antisense oligonucleotide | “GED-0301 is an antisense oligodeoxynucleotide” PMID 28847751 ↗ Aug 2017 |
| Route | Oral | “receiving oral GED-0301 (160 mg/day)” PMID 28847751 ↗ Aug 2017 |
| Target | SMAD7 | “an antisense oligodeoxynucleotide to Smad7” PMID 31850931 ↗ May 2020 |