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

Running, not enrolling · Phase 2

Conditions studied: Crohn Disease, Colitis, Ulcerative

In brief

The primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult participants with inflammatory bowel disease (IBD). Secondary objectives of the study are to: * evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD * evaluate the safety and tolerability of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD * evaluate the immunogenicity of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD The total duration for a participant in the double-blind period only is 66 weeks; and for a participant in the open-label extension (OLE) period, up to an additional 268 weeks.

Key facts

Study ID

NCT05668013

Run by

Teva Branded Pharmaceutical Products R&D LLC

People needed

247

Starts

2023-01-11

Expected to finish

2031-03-08

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Maintenance Period- Participants who achieved clinical response and/or clinical remission at week 14 of TV48574-IMM-20036 (the 14-week DRF study) or in the re-induction period of this study.
• Re-induction- Participants who did not achieve clinical response and/or clinical remission at week 14 of the TV48574-IMM-20036 DRF study
• NOTE- Additional criteria may apply, please contact the investigator for more information

You may not qualify if…

• Participants who discontinued the TV48574-IMM-20036 study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons)
• 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.
• 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

Where it is running

• Teva Investigational Site 15357 — Kissimmee, Florida, United States
• Teva Investigational Site 15375 — Orlando, Florida, United States
• Teva Investigational Site 15359 — Pinellas Park, Florida, United States
• Teva Investigational Site 15567 — Gurnee, Illinois, United States
• Teva Investigational Site 15574 — New Albany, Indiana, United States
• Teva Investigational Site 15367 — Kansas City, Kansas, United States
• Teva Investigational Site 15575 — Louisville, Kentucky, United States
• Teva Investigational Site 15358 — Liberty, Missouri, United States
• Teva Investigational Site 15373 — St Louis, Missouri, United States
• Teva Investigational Site 15369 — Las Vegas, Nevada, United States
• Teva Investigational Site 15750 — Beavercreek, Ohio, United States
• Teva Investigational Site 15559 — Harlingen, Texas, United States
• Teva Investigational Site 15366 — Katy, Texas, United States
• Teva Investigational Site 15374 — San Antonio, Texas, United States
• Teva Investigational Site 15565 — Southlake, Texas, United States
• Teva Investigational Site 15361 — Tyler, Texas, United States
• Teva Investigational Site 15364 — Salt Lake City, Utah, United States
• Teva Investigational Site 33056 — Vienna, Austria
• Teva Investigational Site 59243 — Gorna Oryahovitsa, Bulgaria
• Teva Investigational Site 59197 — Sofia, Bulgaria
• Teva Investigational Site 59196 — Sofia, Bulgaria
• Teva Investigational Site 54221 — Brno, Czechia
• Teva Investigational Site 54222 — Klatovy, Czechia
• Teva Investigational Site 54220 — Slaný, Czechia
• Teva Investigational Site 15556 — San Diego, California, United States

Full record on ClinicalTrials.gov

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