3 completed, 3 terminated, 1 withdrawn. 3 Phase 3, 2 Phase 1, 2 Phase 2.
By phase and status
Follow GED0301: new trials by email Literature Review of GED0301 trials Research Report on GED0301
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease GED-0301, Placebo - Crohn Disease | Phase 3 | Withdrawn | | 2017-12-01 | 2017-11-14 |
A Study to Evaluate the Effect of Food, Formulation Strength, and a Proton Pump Inhibitor on GED 0301 Pharmacokinetics in Healthy Adult Subjects GED-0301, Omeprazole - Healthy Volunteers | Phase 1 | Completed | 18 | 2016-11-01 | 2017-01-12 |
A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease GED-0301, Placebo - Crohn's Disease | Phase 3 | Terminated | 310 | 2016-07-25 | 2019-01-29 |
Pharmacodynamic and Clinical Outcome Study of Mongersen in Patients With Crohn's Disease GED-0301 - Crohn's Disease | Phase 2 | Terminated | 18 | 2016-04-04 | 2018-08-14 |
An Efficacy and Safety Study of Mongersen (GED-0301) in Subjects With Active Ulcerative Colitis GED-0301 - Colitis, Ulcerative | Phase 2 | Completed | 41 | 2015-12-14 | 2018-10-17 |
Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease GED-0301, Placebo - Crohn Disease | Phase 3 | Terminated | 701 | 2015-12-08 | 2019-08-28 |
A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease GED-0301, Placebo - Crohn Disease | Phase 1 | Completed | 64 | 2015-04-08 | 2019-01-10 |
Conditions studied
Crohn Disease (5) · Colitis, Ulcerative (1) · Irritable Bowel Syndrome (1)
Sponsors
Celgene (7)
Countries
Canada (5) · Hungary (5) · Slovakia (5) · United States (5) · Australia (4) · Italy (4) · Poland (4) · United Kingdom (4) · Austria (3) · Belgium (3) · Bulgaria (3) · Croatia (3) · Czechia (3) · Denmark (3) · France (3)
Top investigators
Guillermo Rossiter, MD (3) · Denesh Chitkara, MD (1) · Keith Usiskin, M.D (1) · Keith Usiskin, MD (1) · Maria Palminsano, MD (1)
Results publications
PMID 28847751, PMID 31850931, PMID 33871807