A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease (NCT05668013)
A Phase 2b, Randomized, Double-Blind Long-Term Extension Study to Evaluate Pharmacokinetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Completed the Treatment Phase of the Dose-Ranging Study (RELIEVE UCCD LTE)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Teva Investigational Site 15556 — San Diego, California
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (93 Sites)
Showing the first 25 of 93 sites.
- Teva Investigational Site 15556 — San Diego, California
- Teva Investigational Site 15357 — Kissimmee, Florida
- Teva Investigational Site 15375 — Orlando, Florida
- Teva Investigational Site 15359 — Pinellas Park, Florida
- Teva Investigational Site 15567 — Gurnee, Illinois
- Teva Investigational Site 15574 — New Albany, Indiana
- Teva Investigational Site 15367 — Kansas City, Kansas
- Teva Investigational Site 15575 — Louisville, Kentucky
- Teva Investigational Site 15358 — Liberty, Missouri
- Teva Investigational Site 15373 — St Louis, Missouri
- Teva Investigational Site 15369 — Las Vegas, Nevada
- Teva Investigational Site 15750 — Beavercreek, Ohio
- Teva Investigational Site 15559 — Harlingen, Texas
- Teva Investigational Site 15366 — Katy, Texas
- Teva Investigational Site 15374 — San Antonio, Texas
- Teva Investigational Site 15565 — Southlake, Texas
- Teva Investigational Site 15361 — Tyler, Texas
- Teva Investigational Site 15364 — Salt Lake City, Utah
- Teva Investigational Site 33056 — Vienna,
- Teva Investigational Site 59243 — Gorna Oryahovitsa,
- Teva Investigational Site 59197 — Sofia,
- Teva Investigational Site 59196 — Sofia,
- Teva Investigational Site 54221 — Brno,
- Teva Investigational Site 54222 — Klatovy,
- Teva Investigational Site 54220 — Slaný,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease — Portland, Oregon
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.