Combined Phase 3 Double-blind Randomized Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn s Disease

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Crohn’s Disease
  • Age: Between 18 - 75 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Male subjects or non-pregnant, non-lactating female subjects, ages 18 to 75 years, inclusive based on the date of the screening visit
    2. Subjects must have the ability to understand and sign a written informed consent form
    3. Female subjects of childbearing potential must have a negative pregnancy test at screening and baseline
    4. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the protocol.
    5. Subjects have moderately or severely active CD as per the protocol
    6. Meet one of the following TB screening criteria:
      • No evidence of active or latent TB
      • Previously treated for TB
      • Newly identified latent TB during screening
    7. Subjects with laboratory results as per the protocol
    8. Subjects willing to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose.
    9. Subjects who are up to date on colorectal cancer screening and surveillance as standard of care according to local guidelines.

You may not be eligible for this study if the following are true:

    1. Subjects who are pregnant or lactating
    2. Subjects who are unwilling to abide by protocol-specified contraceptive methods
    3. Female subjects who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting for the purpose of current or future fertilization during the course of the study and up to 35 days after the last dose of the study drug
    4. Male subjects unwilling to refrain from sperm donation during the study and for at least 90 days after the last dose of study drug
    5. Subjects who have known hypersensitivity to filgotinib, its metabolites, or formulation excipients
    6. Subjects currently have complications of CD as described in the protocol
    7. Subjects who have any current or prior abscesses
    8. Subjects who history of major surgery or trauma within 30 days prior to screening
    9. Subjects with presence of UC, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
    10. Subjects with history of total colectomy, subtotal colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study
    11. Subjects who have dependence on parenteral nutrition
    12. Subjects who have history or evidence of incompletely resected colonic mucosal dysplasia
    13. Subjects with stool sample positive for certain medical conditions as listed in the protocol
    14. Subjects infected with HIV, hepatitis B, or hepatitis C
    15. Subjects with Child-Pugh Class C hepatic impairment
    16. Subjects with active TB or history of latent TB that has not been treated.
    17. Subjects with history of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder, or multiple myeloma
    18. Subjects with history of treatment with lymphocyte-depleting therapies, including but not limited to alemtuzumab, cyclophosphamide, total lymphoid irradiation, and rituximab
    19. Subjects who have history of cytapheresis =2 months prior to screening
    20. Subjects who use any prohibited concomitant medications as per the protocol
    21. Subjects who have administration of a live or attenuated vaccine within 30 days of randomization
    22. Subjects currently on any chronic systemic (oral or intravenous) anti-infective therapy for chronic infection
    23. Subjects with the history of disseminated Staphylococcus aureus
    24. Subjects with history of symptomatic herpes zoster or herpes simplex within 12 weeks of screening, or any history of disseminated herpes simplex, disseminated herpes zoster, ophthalmic zoster, or central nervous system zoster

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