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Pharmacodynamic and Clinical Outcome Study of Mongersen in Patients With Crohn's Disease

NCT02685683 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-08-14

No results posted yet for this study

Summary

This study is designed to explore mechanism of action of mongersen (GED-0301) 160 mg once daily in patients with active Crohn's Disease

Conditions

Interventions

DRUG

GED-0301

During Induction period patient will receive mongersen 160 mg daily for 12 weeks. This study also offers subjects the option to continue with maintenance treatment at the discretion of the Investigator, beginning after the Week 12 Visit with alternating no IP for 4 weeks, followed by mongersen (GED-0301) 160 mg QD for 4 weeks, up through the Week 52 Visit during the Maintenance Period. At Week 52, subjects who have achieved an endoscopic improvement of \>50% from baseline based on the SES-CD, as assessed by the central reader, and clinical improvement (HBI \<7), will have the option to continue receiving treatment for an additional year, up through Year 2 (ie, the Week 100 Visit).

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Keith Usiskin, MD · Celgene

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-04
Primary Completion
2017-09-25
Completion
2017-11-09

Countries

  • Italy

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 NCT02685683 on ClinicalTrials.gov