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

NCT02768974 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-09-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

OPRX-106

Oral delivery, once daily.

Sponsors & Collaborators

  • Protalix

    lead INDUSTRY

Principal Investigators

  • Einat Dekel, DVM · Sr. Director Clinical Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-02-28

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02768974 on ClinicalTrials.gov