drugset / Trial / NCT03169894
Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase 1b, open-label, dose-escalation, signal-finding, multi-center study. The study will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of MDGN-002 in adults with moderate to severe, active Crohn's disease or Ulcerative Colitis who have previously failed anti-tumor necrosis factor alpha (anti-TNFα) treatment.
Timeline
- Start
- 2017-07-14
- Primary completion
- 2021-09-14
- Completion
- 2021-10-12
Outcome
Outcome not reported
Stopped (Business): “Strategic reasons”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | QUISOVALIMAB | Monoclonal antibody | 1 mg/kg | Subcutaneous |
| Subject | QUISOVALIMAB | Monoclonal antibody | 3 mg/kg | Subcutaneous |