A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1414

Inclusion Criteria

1. Subject is a male or female = 18 years of age at the time of signing the informed consent form (ICF).
2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
4. Subject must have completed through Week 12 in the previous GED-0301 study AND either:
Completed participation through the last study treatment visit
at Week 52 in Study GED-0301-CD-002 or at Week 12 in Study GED-0301-CD-003 OR Met the early escape criteria” and were discontinued after Week 12 in Study GED-0301-CD-002.
5. Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and enrollment (Visits 1 and 2). While on IP and for at least 28 days after taking the last dose of IP, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options
6. Male subjects when engaging in sexual activity with females who are able to become pregnant must use barrier contraception while on IP and for at least 28 days after the last dose.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1343
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 71

Exclusion Criteria

1. Subject had experienced a serious adverse event related to the IP while participating in the previous Phase 3 GED-0301 study.
2. Subject has any continuing serious medical condition, laboratory abnormality, or psychiatric illness that occurred while participating in the previous Phase 3 GED-0301 study.
3. Subject has or had a flare or worsening of CD that, in the opinion of the Investigator, would not be in the best interest for the subject to participate in this long-term active treatment study.
4. Subject has initiated biologic agents, such as TNF-a blockers or integrin antagonists.
5. Subject has been diagnosed with colorectal cancer or colorectal dysplasia (with the exception of adenomatous colonic polyps that have been completely resected) while participating in the previous Phase 3 GED-0301 study.
6. Subject has a newly diagnosed malignancy while participating in the previous Phase 3 GED-0301 study.
7. Subject is pregnant or breastfeeding.
8. Subject has been newly diagnosed with substance abuse.
9. Subject has developed a known hypersensitivity to oligonucleotides, GED-0301 or any ingredient in the IP.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety of oral GED-0301 in subjects with Crohn’s disease;Secondary Objective: Secondary objectives are not included in this study.;Primary end point(s): Safety of GED-0301, assessed by type, frequency and severity of adverse events, and its relationship to investigational product, discontinuation due to adverse events, and clinically significant changes in electrocardiograms (ECGs), vital signs, and/or laboratory findings;Timepoint(s) of evaluation of this end point: Through Week 208 and 4 weeks postdose

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints are not included in this study.;Timepoint(s) of evaluation of this end point: not applicable

Updated 8/3/2020

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

Recruitment & Eligibility

Study & Design

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