drugset / Trial / NCT02768974

Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis

NCT02768974 ↗

Phase 2 Unknown 20 enrolled Protalix
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with active mild to moderate ulcerative colitis. Eligible subjects will be enrolled and randomized to receive 2 mg or 8 mg of OPRX-106 administered orally, once daily for 8 weeks.

Timeline

Start
2016-09
Primary completion
2017-02
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject OPRX-106 Protein / enzyme biologic 2 mg Oral
Subject OPRX-106 Protein / enzyme biologic 8 mg Oral

Indications