chronic bowel inflammation inflammatory bowel disease
Conditions
Interventions
Subjects will receive blinded-active GED-0301 treatment during the 208-week
Long-term Active Treatment Period. GED-0301 will be provided as 40-mg
film-coated tablets or matching placebo tablets in b
Sponsors
Celgene Corporation
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
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.;Inclusion Criteria for Adolscent Subjects: 1. male or female, 12 to 17 years of age at the time of assent/informed consent in core GED-0301-CD-003 study and must affirmatively agree to participate in this study by signing an assent with a parent/legal guardian who can understand and voluntarily sign an ICF. Adolescent subjects who turn 18 by the screening visit for GED-0301-CD- 004 study must also understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. 2. able to swallow the IP tablets. 3. willing and able to adhere to study visit schedule and protocol requirements, and a parent or legal guardian willing to supervise adherence to protocol requirements. 4. must have completed through the Week 12 Visit in Study GED-0301- CD-003. 5. Females of childbearing potential (FCBP)5 must have a negative pregnancy test at screening and enrollment (Visits 1 and 2). FCBP must either practice true abstinence from heterosexual contact or use one of the approved contraceptive options while on IP and for at least 28 days after taking the last dose of IP.
Exclusion criteria
Exclusion criteria: 1. Subject had experienced a serious adverse event related to the IP while participating in the core Phase 3 GED-0301 study. 2. Subject has any continuing serious medical condition, laboratory abnormality, or psychiatric illness that occurred while participating in the core 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 while, or after participating in the core Phase 3 GED-0301 study. 5. Subject diagnosed with colorectal cancer or confirmed diagnosis of colorectal dysplasia (with the exception of adenomatous colonic polyps that have been completely resected) while participating in the core Phase 3 GED-0301 study. 6. newly diagnosed malignancy while participating in the previous Phase 3 GED-0301 study. 7. pregnant or breastfeeding. 8. Subject has been newly diagnosed with substance abuse. 9. New condition that may put subject at risk or confound the ability to interpret data from the study. 9. known hypersensitivity to oligonucleotides, GED-0301 or any ingredient in the IP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Through Week 208 and 4 weeks postdose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are not included for adult subjects in this study. Secondary endpoints for Adolescents subjects from GED-0301-CD-003: - The proportion of subjects with clinical remissiona at Week 40. - The proportion of subjects with endoscopic remission defined as SESCD | — |
Countries
Netherlands
Outcome results
None listed