UNIFI Ustekinumab for Subjects With Ulcerative Colitis

Condition

  • Ulcerative colitis

Study Name

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis (IRB no. 40966)

Summary

The purpose of this study is to evaluate the investigational use of a drug called ustekinumab in treating patients with moderately to severely active ulcerative colitis. Specifically, researchers aim to learn about the effectiveness of ustekinumab induction and maintenance therapy compared to the current, standard-of-care therapies. Researchers will compare the effects of ustekinumab against the effects of a placebo (inactive substance) to determine its safety and effectiveness.

Eligibility

Key Inclusion Criteria:

  • At least 18 years old
  • Diagnosis of ulcerative colitis at least three months before screening
  • Moderately or severely active ulcerative colitis

Key Exclusion Criteria:

  • Severe extensive colitis
  • Ulcerative colitis limited to the rectum only or to less than 20 cm of the colon
  • Presence of a stoma

Please see additional list of inclusion and exclusion criteria.

Principal Investigator

Gil Melmed, MD

Contact

Elizabeth Khanishian
Phone: 310-423-2041
Email: elizabeth.khanishian@cshs.org