A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
- Registration Number
- NCT02641392
- Lead Sponsor
- Celgene
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 310
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GED-0301 (160 mg) followed by Placebo intermittent 160 mg GED-0301 GED-0301 160 mg once daily (QD) for 12 weeks, followed by alternating Placebo (PBO) QD for 4 weeks with GED 0301 160 mg QD for 4 weeks, up to 208 weeks, if the subject previously received Placebo in the prior GED-0301 Study Intermittent GED-0301 160 mg and placebo GED-0301 Alternating GED-0301 160 mg once daily (QD) for 4 weeks with placebo (PBO) QD for 4 weeks, up to 208 weeks, depending on previous response in the prior GED-0301 study Intermittent GED-0301 160 mg and placebo Placebo Alternating GED-0301 160 mg once daily (QD) for 4 weeks with placebo (PBO) QD for 4 weeks, up to 208 weeks, depending on previous response in the prior GED-0301 study Intermittent placebo and GED-0301 40 mg Placebo Alternating PBO once daily (QD) for 4 weeks with GED-0301 40 mg QD for 4 weeks with, up to 208 weeks, depending on previous response in the prior GED-0301 study Continuous GED-0301 40 mg GED-0301 GED-0301 40 mg once daily (QD) for up to 208 weeks Intermittent placebo and GED-0301 160 mg GED-0301 Alternating PBO QD for 4 weeks with GED-0301 160 mg QD for 4 weeks, through Week 208 Intermittent placebo and GED-0301 160 mg Placebo Alternating PBO QD for 4 weeks with GED-0301 160 mg QD for 4 weeks, through Week 208 Intermittent placebo and GED-0301 40 mg GED-0301 Alternating PBO once daily (QD) for 4 weeks with GED-0301 40 mg QD for 4 weeks with, up to 208 weeks, depending on previous response in the prior GED-0301 study
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208 From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of GED-0301 and up to 28 days after the last GED- 0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale; Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (231)
Medical Associates Research Group Inc.
🇺🇸San Diego, California, United States
Atlanta Gastroenterology Associates, LLC
🇺🇸Atlanta, Georgia, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Health Science Research Center, LLC
🇺🇸Pratt, Kansas, United States
Via Christi Research a division of Via Christi Hospitals Wichita Inc
🇺🇸Wichita, Kansas, United States
Gastroenterology Associates LLC
🇺🇸Baton Rouge, Louisiana, United States
Metropolitan Gastroenterology
🇺🇸Chevy Chase, Maryland, United States
Clinical Research Institute of Michigan, LLC
🇺🇸Chesterfield, Michigan, United States
Gastroenterology Associates of Western Michigan PLC
🇺🇸Wyoming, Michigan, United States
Ehrhardt Clinical Research LLC
🇺🇸Belton, Missouri, United States
Scroll for more (221 remaining)Medical Associates Research Group Inc.🇺🇸San Diego, California, United States