Ensayos clínicos

Inclusion Criteria:

• Male or female subjects aged 12 to 75 years (at Screening), inclusive with adolescents (12 to 17 years) with a body weight ≥ 45 kg.
  • Note: Countries or sites with local restrictions that prohibit enrollment of adolescents (aged 12 to 17 years) will only enroll subjects who are 18 years of age or older. Enrollment of adolescent subjects will begin only after the applicable regulatory requirements for enrolling subjects in that age group have been satisfied and the necessary health authority agreements have been granted. Where national or regional guidelines for the definition of adolescence differ from the definition stated above, the national or regional guidelines may be used to determine eligibility.
• Crohn's disease for ≥ 3 months on endoscopy and on histological exam
• Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy
• Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
• Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
• Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease).

Exclusion Criteria:

• Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention.
• Extensive small bowel resection (> 100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition.
• Current stoma, ileal-anal pouch anastomosis, or fistula.
• Subject has a known active bacterial, viral, fungal (excluding fungal infection of nail beds, minor upper respiratory tract infections, and minor skin infections), mycobacterial infection (including tuberculosis [TB] or atypical mycobacterial disease) or any major episode of infection that required hospitalization or treatment with intravenous (IV) antibiotics within 30 days of Screening or oral antibiotics within 14 days of Screening:
  • In the case of known SARS-CoV-2 infection, symptoms must have completely resolved, SARS-CoV-2 re-test results must be negative, and based on Investigator assessment in consultation with the Clinical Trial Physician / Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment.

Eligibility last updated 11/23/21. Questions regarding updates should be directed to the study team contact.