TD-1473 in Crohn's Disease

Condition: Crohn's disease

Eligibility

Key Inclusion Criteria

  • At least 18 years old
  • History of Crohn's disease with involvement of at least the ileum or any portion of the colon at a minimum
  • Must have up-to-date colorectal cancer screening, per locally adopted guidelines

Key Exclusion Criteria

  • Current symptoms or signs suggestive of intestinal perforation, intra-abdominal or pelvic abscess or symptomatic stricture
  • Diagnosis of indeterminate colitis, ulcerative colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis or suspected ulcerative colitis
  • Confirmed or suspected diagnosis or history of primary sclerosing cholangitis

Full Study Name

A Phase II Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects With Moderately to Severely Active Crohn's Disease (IRB no. 57123)

Summary

The purpose of this study is to evaluate the effectiveness of an investigational drug called TD-1473 in individuals with Crohn's disease. Specifically, the study will assess the safety and tolerability of TD-1473, as well as its effect on quality of life. Researchers will measure the way the body absorbs, distributes and gets rid of the study drug (pharmacokinetics), in addition to examining the effects of the drug on the human body (pharmacodynamics). The study will also explore whether the drug has any impact on Crohn's disease symptoms, disease severity and/or the levels of proteins or RNA (biologic products the body makes) that are associated with Crohn's disease.

Phase

Phase II

Principal Investigator

Gil Melmed, MD

Contact
Melissa Hampton
Phone: 310‐423‐0035
Email: melissa.hampton@cshs.org