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.
The GED-0301-CD-003 trial was not initiated; see detailed description.
Brief Title
A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Crohn's Disease
Eligibility Criteria
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.
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.
Inclusion Criteria
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.
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.
Gender
All
Gender Based
false
Keywords
Crohn's Disease
GED 0301
Mongersen
Safety
Irritable Bowel Disease
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
12 Years
NCT Id
NCT02641392
Org Class
Industry
Org Full Name
Celgene
Org Study Id
GED-0301-CD-004
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
Primary Outcomes
Outcome Description
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.
Outcome Measure
Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208
Outcome Time Frame
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
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Dana Lukin
Investigator Email
dlukin@montefiore.org
Investigator Phone
917-769-8594
Categories Mesh Debug
Digestive System --- CROHN DISEASE
Digestive System --- INFLAMMATORY BOWEL DISEASES
Digestive System --- GASTROENTERITIS
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL DISEASES
Digestive System --- GASTROINTESTINAL DISEASES
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Gastrointestinal (GI) Cancers --- INTESTINAL DISEASES
Digestive System --- INTESTINAL DISEASES
Gastrointestinal (GI) Cancers --- COLONIC DISEASES
Digestive System --- COLONIC DISEASES
MeSH Terms
CROHN DISEASE
IRRITABLE BOWEL SYNDROME
INFLAMMATORY BOWEL DISEASES
GASTROENTERITIS
GASTROINTESTINAL DISEASES
DIGESTIVE SYSTEM DISEASES
INTESTINAL DISEASES
COLONIC DISEASES, FUNCTIONAL
COLONIC DISEASES
GED0301
COUNTERFEIT DRUGS
SUBSTANDARD DRUGS
PHARMACEUTICAL PREPARATIONS