drugset / Trial / NCT02647866
Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis
RandomizedSequentialQuadruple-blindTreatment
Summary
The purpose of this study is to determine the safety and tolerability of administration of multiple ascending doses of KHK4083 and to select the highest dose tolerated by subjects with moderately active Ulcerative Colitis (UC) followed by a Long-term Extension Therapy (LTE) phase for eligible subjects with a clinical response.
Timeline
- Start
- 2016-06
- Primary completion
- 2018-09
- Completion
- 2018-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rocatinlimab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Rocatinlimab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Rocatinlimab | Monoclonal antibody | 10 mg/kg | Intravenous |