A Phase 2 Randomized Double-Blind Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe 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. Subjects willing to complete all study specific procedures and visits and complete the consent form
    2. Subjects diagnosed with CD as per the protocol
    3. Subjects who are between the ages of 18 and 75 years old
    4. Female Subjects of child-bearing potential have negative pregnancy test, not lactate, and agree to used effective contraception for the duration of the study and 33 days after the completion of the treatment
    5. Male Subjects who are sexually active must use effective contraception methods for the duration of the study and 33 days after the completion of the treatment

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

    1. Subjects who have severe or fulminant colitis that is likely to require surgery or hospitalization
    2. Subjects who have presence of a diagnosis of alternative forms of colitis, stoma, gastric or ileoanal pouch, previous proctocolectomy or total colectomy, symptomatic, obstructive disease such as stenosis or obstructive strictures, abscess or suspected abscess, pouchitis, short bowel syndrome, or history of bowel perforation
    3. Subjects with history of intra-abdominal abscess or diverticulitis or have history of infectious (bacterial, viral, fungal, parasitic, etc.) colitis
    4. Subjects who use of therapeutic enema or suppository, other than required for ileocolonoscopy, within 7 days prior to screening
    5. Subjects who had prior treatment with specific lymphocyte-depleting agents
    6. Subjects who had previous exposure to BMS-986165 in any study
    7. Subjects with previous stem cell transplantation
    8. Subjects with previous treatment with investigational agents
    9. Subjects who are pregnant or lactating
    10. Subjects with history of malignancy other than treated carcinoma
    11. Subjects who has inability to tolerate oral medication, or undergo venipuncture
    12. Subjects who had significant blood loss
    13. Subjects with the inability to comply with restrictions and prohibited treatments
    14. Subjects who had clinically significant abnormalities on chest x-ray or ECG or in laboratory testing as per the protocol
    15. Subjects who have history of any significant drug allergy
    16. Subjects who are prisoners or subjects who are involuntarily incarcerated or detained for treatment of either psychiatric or physical illness



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