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An Efficacy and Safety Study of Mongersen (GED-0301) in Subjects With Active Ulcerative Colitis

NCT02601300 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2018-10-17

Study results available
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Summary

This is a phase 2, open-label, multicenter study to explore the efficacy and safety of oral GED- 0301 in subjects with active UC, defined as a modified Mayo score (MMS) ≥ 4 and ≤ 9 and a Mayo endoscopic subscore≥ 2.

Approximately 40 subjects will be enrolled using an Interactive Voice Response System (IVRS) or an Interactive Web Response System (IWRS) to receive open-label, oral GED-0301 160 mg for duration of 52 week treatment. Enrollment of subjects with previous exposure to TNF-α blockers will be limited to approximately 15 subjects. The number of subjects with extensive colitis is targeted to comprise approximately 50% of the entire study population.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

GED-0301

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Keith Usiskin, M.D · Celgene Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-14
Primary Completion
2016-09-06
Completion
2017-08-08

Countries

  • United States
  • Bulgaria
  • Canada
  • Hungary
  • Poland
  • Slovakia

Study Locations

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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 NCT02601300 on ClinicalTrials.gov