A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
Crohn Disease, Colitis, Ulcerative
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility Criteria
Inclusion Criteria: Participants achieved clinical response and/or clinical remission in the 14-week TV48574-IMM-20036 DRF study Participants who are women of childbearing potential (WOCBP) should have a negative β-human chorionic gonadotropin test result and practice a highly effective method of birth control Male participants (including vasectomized) with WOCBP partners should use condoms after the first IMP administration and throughout the study NOTE- Additional criteria may apply, please contact the investigator for more information Exclusion Criteria: Participants who discontinued the TV48574-IMM-20036 study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons) and participants who didn't meet the definition of clinical response or clinical remission based on their DRF week 14 assessment Participant has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the participant at increased risk during the study as judged by the investigator and/or the clinical study physician. Participant anticipates requiring major surgery during this study. Participants with clinical symptoms that may indicate coronavirus disease 2019 (COVID-19) infection Participant is currently pregnant or lactating or is planning to become pregnant or to lactate during the study or for at least 50 days after administration of the last dose of IMP in case of early termination. Any woman becoming pregnant during the study will be withdrawn from the study. NOTE- Additional criteria apply, please contact the investigator for more information
Sites / Locations
- Teva Investigational Site 15357Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
TEV-48574 Dose Regimen A for Ulcerative Colitis (UC)
TEV-48574 Dose Regimen A for Crohn's Disease (CD)
TEV-48574 Dose Regimen B for Ulcerative Colitis (UC)
TEV-48574 Dose Regimen B for Crohn's Disease (CD)
Administered by subcutaneous infusion for participants with UC
Administered by subcutaneous infusion for participants with CD
Administered by subcutaneous infusion for participants with UC
Administered by subcutaneous infusion for participants with CD