6 completed, 1 withdrawn. 7 Phase 2, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 6, Withdrawn 1 |
| Phase 1 | 1 | Withdrawn 1 |
Follow VBP15 compound: new trials by email Literature Review of VBP15 compound trials Research Report on VBP15 compound
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 to Assess Vamorolone in Becker Muscular Dystrophy (BMD) Vamorolone, Placebo - Becker Muscular Dystrophy | Phase 2 | Completed | ReveraGen BioPharma, Inc. | 46 | 2022-07-07 | 2026-09-15 |
| A Study to Assess Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD) Vamorolone - Duchenne Muscular Dystrophy | Phase 2 | Completed | Santhera Pharmaceuticals | 54 | 2022-03-21 | 2025-10-24 |
| Proof of Concept Trial of Vamorolone in Pediatric Ulcerative Colitis Vamorolone 4% suspension for oral dosing - Pediatric Ulcerative Colitis | Phase 1 / Phase 2 | Withdrawn | ReveraGen BioPharma, Inc. | 2020-09-01 | 2020-09-29 | |
| A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) Vamorolone, Prednisone, Placebo - Duchenne Muscular Dystrophy | Phase 2 | Completed | ReveraGen BioPharma, Inc. | 121 | 2018-06-29 | 2023-03-09 |
| Long-term Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) Vamorolone 0.25 mg/day/day, Vamorolone 0.75 mg/day/day, Vamorolone 2.0 mg/day/day - Duchenne Muscular Dystrophy | Phase 2 | Completed | ReveraGen BioPharma, Inc. | 46 | 2017-02-02 | 2021-05-20 |
| An Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) Vamorolone 0.25 mg/day/day, Vamorolone 0.75 mg/day/day, Vamorolone 2.0 mg/day/day - Duchenne Muscular Dystrophy | Phase 2 | Completed | ReveraGen BioPharma, Inc. | 48 | 2016-07-28 | 2019-07-23 |
| A Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) Vamorolone 0.25 mg/kg/day, Vamorolone 0.75 mg/kg/day, Vamorolone 2.0 mg/kg/day - Duchenne Muscular Dystrophy | Phase 2 | Completed | ReveraGen BioPharma, Inc. | 48 | 2016-06-01 | 2019-01-02 |
Muscular Dystrophy, Duchenne (6) · Muscular Dystrophies (2) · Pediatric ulcerative colitis (1)
ReveraGen BioPharma, Inc. (6) · Santhera Pharmaceuticals (1)
Canada (5) · United States (5) · Australia (4) · Israel (4) · Sweden (4) · United Kingdom (4) · Belgium (1) · Czechia (1) · Greece (1) · Italy (1) · Netherlands (1) · Spain (1)
Paula R Clemens, MD (3) · Paula Clemens, M.D. (2) · Jean K Mah, M.D. (1) · Laurie Conklin, MD (1) · Michela Guglieri, M.D. (1)
PMID 32956407, PMID 42613652, PMID 32434278, PMID 38521535, PMID 35076703, PMID 36036925, PMID 38335499, PMID 40957504, PMID 41774261, PMID 42139656, PMID 42202243, PMID 42547787
R44NS095423 (2), U34AR068616 (2)