Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:26 PM
Ignite Modification Date:
2025-12-24 @ 3:26 PM
NCT ID:
NCT02641392
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT02641392
Study Brief:
Protocol Section:
NCT02641392