A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease



Status:Terminated
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:12 - Any
Updated:1/31/2019
Start Date:July 25, 2016
End Date:January 4, 2018

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A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

The purpose of this study is to assess long-term safety data of GED-0301 for a period of up
to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3
GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of
age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will
receive active treatment, this study is double-blinded for the entire 208 weeks for the
purpose of preserving the blind of the subject's treatment allocation in the initial, core
Phase 3 GED-0301 study.

The GED-0301-CD-003 trial was not initiated; see detailed description.

This is a long-term active treatment study in patients with Crohn's disease (CD). Subjects
who met the early escape criteria in Study GED-0301-CD-002, or subjects who completed Study
GED-0301-002 or GED-0301-003, may be eligible for this study. Primary objective is to assess
long-term safety of GED 0301. Additional efficacy and patient reported outcomes will be
explored.

There are 5 possible treatment groups for GED-0301-CD-002 Subjects (Groups 1-5). There are 3
possible treatment groups for GED-0301-CD-003 subjects (Groups 1-3). Treatment is assigned
based on clinical improvement achieved or not achieved from the core GED-0301 study.

1. continuous GED-0301 160 mg once daily for 12 weeks, followed by alternating placebo once
daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks, through Week 208;

2. alternating GED-0301 160 mg once daily for 4 weeks with placebo once daily for 4 weeks,
through Week 208;

3. alternating placebo once daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks,
through Week 208;

4. continuous GED-0301 40 mg once daily through Week 208;

5. alternating placebo once daily for 4 weeks, followed by GED-0301 40 mg once daily for 4
weeks, through Week 208.

The GED-0301-CD-003 trial was not initiated; the GED-0301 program was terminated; no safety
findings were noted.

Inclusion Criteria for Adult Subjects:

Subjects must satisfy the following criteria to be screened and enrolled in the study:

- Male or female ≥ 18 years of age.

- Subject must have participated in the GED-0301-CD-002 or GED 0301 CD 003 study.

- Subject must use protocol approved contraception.

Inclusion Criteria for Adolescent Subjects:

Adolescent subjects must satisfy the following criteria to be screened and enrolled in the
study

- Male or female 12 to 17 years of age.

- Subject must have participated in the GED 0301 CD 003 study.

- Subject is able to swallow the IP tablets.

- Subject must use protocol approved contraception.

Exclusion Criteria for Adult and Adolescent Subjects:

The presence of any of the following will exclude a subject from screening and enrollment:

- Subject had experienced a serious adverse event (SAE) related to the investigational
product while participating in the previous Phase 3 GED-0301 study.

- Subject has initiated biologic agents, such as TNF-α blockers or integrin antagonists.

- Subject is pregnant or breastfeeding.

- Subject has developed a known hypersensitivity to oligonucleotides, GED 0301 or any
ingredient in the investigational product.
We found this trial at
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Arlington, Texas 76012
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Atlanta, Georgia 30342
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Baton Rouge, Louisiana 70809
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Belton, Missouri 64012
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Chattanooga, Tennessee 37421
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Chesterfield, Michigan 48098
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Chevy Chase, Maryland 20815
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Concord, New South Wales
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3409 Worth Street
Dallas, Texas 75231
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4370 Medical Arts Drive
Flower Mound, Texas 75028
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Pratt, Kansas 67124
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San Antonio, Texas 78229
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San Diego, California 92123
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Seattle, Washington 98101
(888) 862-2737
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Vancouver, Washington 98664
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Wilmington, North Carolina 28403
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