TEV-48574 for Inflammatory Bowel Disease
Trial Summary
What is the purpose of this trial?
This trial tests a new drug called TEV-48574, given as a shot periodically, in adults with inflammatory bowel disease. It aims to see how well the drug works, how safe it is, and how the body reacts to it.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to contact the study investigator for more details.
What data supports the effectiveness of the drug TEV-48574 for treating Inflammatory Bowel Disease?
Research on similar treatments, like V565 and AVX-470, shows that drugs targeting tumor necrosis factor (TNF) can reduce inflammation in the intestines of patients with ulcerative colitis, a type of inflammatory bowel disease. These drugs work by neutralizing TNF, a protein that contributes to inflammation, suggesting that TEV-48574 might have similar benefits.12345
Research Team
Teva Medical Expert, MD
Principal Investigator
Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility Criteria
This trial is for adults with moderate to severe Ulcerative Colitis or Crohn's Disease who showed improvement in a previous 14-week study. Women must not be pregnant, should test negative for pregnancy, and use effective birth control. Men with partners of childbearing potential must use condoms.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TEV-48574 subcutaneous infusions every 4 weeks in a double-blind period
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may opt into continuation of treatment long-term with TEV-48574
Treatment Details
Interventions
- TEV-48574
Find a Clinic Near You
Who Is Running the Clinical Trial?
Teva Branded Pharmaceutical Products R&D, Inc.
Lead Sponsor
Dr. Eric Hughes
Teva Branded Pharmaceutical Products R&D, Inc.
Chief Medical Officer since 2022
MD and PhD from Yale School of Medicine
Richard Francis
Teva Branded Pharmaceutical Products R&D, Inc.
Chief Executive Officer since 2022
Bachelor's degree in Biochemistry from the University of Manchester
Sanofi
Industry Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University