A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

• Status: Not yet recruiting
• Trial end date: 2025-06-22
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to evaluate the efficacy and dose response of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 2 weeks (Q2W) in adult participants with inflammatory bowel disease (IBD)

Secondary objectives of the study are to evaluate the efficacy and dose response of 2 different maintenance dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD to evaluate the safety and tolerability of 2 different dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD, and to evaluate the immunogenicity of 2 different dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD

The total duration of participant participation in the study is planned to be 26 weeks for each individual participant. The study duration is approximately 30 months.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Criteria

Inclusion Criteria:

• Participants who at the time of informed consent 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