About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Participants achieved clinical response and/or clinical remission in the 14-week TV48574-IMM-20036 DRF study
2. 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
3. Male participants (including vasectomized) with WOCBP partners should use condoms after the first IMP administration and throughout the study NOTE
4. Additional criteria may apply, please contact the investigator for more information

Exclusion criteria

1. 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
2. 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.
3. Participant anticipates requiring major surgery during this study.
4. Participants with clinical symptoms that may indicate coronavirus disease 2019 (COVID-19) infection
5. 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
6. Additional criteria apply, please contact the investigator for more information

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.