A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

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.

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

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Shabana Pasha, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20348164

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