drugset / Trial / NCT03800420
Efficacy and Safety of BBT-401-1S in Ulcerative Colitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is randomized, placebo-controlled, dose-escalation, multicenter, Phase 2 study to evaluate the efficacy and safety of BBT-401-1S in patients with active ulcerative colitis. This study consists of three cohorts with 16-week treatment period per cohort that will be conducted sequentially.
Timeline
- Start
- 2019-04-22
- Primary completion
- 2020-05-18
- Completion
- 2020-07-31
Outcome
Outcome not reported
Stopped: “to carry out the rest of the study with new CRO and modified protocol as a multi-regional study.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BBT-401-1S | Peptide | — | Oral |