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A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
Sponsor: Teva Branded Pharmaceutical Products R&D LLC
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
247
Start Date
2023-01-11
Completion Date
2031-03-08
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
TEV-48574 Dose Regimen A
Subcutaneous (sc) administration using a commercial sc infusion system
TEV-48574 Dose Regiment B
Subcutaneous (sc) administration using a commercial sc infusion system
Locations (93)
Teva Investigational Site 15556
San Diego, California, United States
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 81052
Tbilisi, Georgia
Teva Investigational Site 81053
Tbilisi, Georgia
Teva Investigational Site 32793
Kiel, Germany
Teva Investigational Site 32795
Tübingen, Germany
Teva Investigational Site 32794
Ulm, Germany
Teva Investigational Site 32874
Wipperfürth, Germany
Teva Investigational Site 51334
Budapest, Hungary
Teva Investigational Site 51335
Budapest, Hungary
Teva Investigational Site 51338
Vác, Hungary
Teva Investigational Site 80179
Afula, Israel
Teva Investigational Site 80191
Beersheba, Israel
Teva Investigational Site 30285
Milan, Italy
Teva Investigational Site 30286
Milan, Italy
Teva Investigational Site 30284
Rozzano, Italy
Teva Investigational Site 84110
Kashiwa, Japan
Teva Investigational Site 84117
Minato, Japan
Teva Investigational Site 84114
Sakura, Japan
Teva Investigational Site 84116
Shinjuku, Japan
Teva Investigational Site 84111
Toyama, Japan
Teva Investigational Site 41015
Lorenskog, Norway
Teva Investigational Site 53565
Bydgoszcz, Poland
Teva Investigational Site 53542
Częstochowa, Poland
Teva Investigational Site 53543
Elblag, Poland
Teva Investigational Site 53544
Gdansk, Poland
Teva Investigational Site 53546
Katowice, Poland
Teva Investigational Site 53560
Krakow, Poland
Teva Investigational Site 53548
Krakow, Poland
Teva Investigational Site 53512
Krakow, Poland
Teva Investigational Site 53547
Kłodzko, Poland
Teva Investigational Site 53515
Lodz, Poland
Teva Investigational Site 53518
Nowy Targ, Poland
Teva Investigational Site 53549
Poznan, Poland
Teva Investigational Site 53563
Poznan, Poland
Teva Investigational Site 53516
Poznan, Poland
Teva Investigational Site 53566
Poznan, Poland
Teva Investigational Site 53550
Sopot, Poland
Teva Investigational Site 53551
Staszów, Poland
Teva Investigational Site 53508
Szczecin, Poland
Teva Investigational Site 53519
Szczecin, Poland
Teva Investigational Site 53553
Torun, Poland
Teva Investigational Site 53554
Wadowice, Poland
Teva Investigational Site 53557
Warsaw, Poland
Teva Investigational Site 53570
Warsaw, Poland
Teva Investigational Site 53556
Warsaw, Poland
Teva Investigational Site 53555
Warsaw, Poland
Teva Investigational Site 53510
Wroclaw, Poland
Teva Investigational Site 53567
Wroclaw, Poland
Teva Investigational Site 53562
Wroclaw, Poland
Teva Investigational Site 53520
Wroclaw, Poland
Teva Investigational Site 53509
Zamość, Poland
Teva Investigational Site 53511
Łęczna, Poland
Teva Investigational Site 62074
Bardejov, Slovakia
Teva Investigational Site 62073
Bratislava, Slovakia
Teva Investigational Site 62071
Košice, Slovakia
Teva Investigational Site 62076
Prešov, Slovakia
Teva Investigational Site 62097
Prešov, Slovakia
Teva Investigational Site 31293
Huelva, Spain
Teva Investigational Site 31318
Santiago de Compostela, Spain
Teva Investigational Site 31292
Valencia, Spain
Teva Investigational Site 58327
Chernivtsi, Ukraine
Teva Investigational Site 58324
Ivano-Frankivsk, Ukraine
Teva Investigational Site 58329
Lviv, Ukraine
Teva Investigational Site 58325
Lviv, Ukraine
Teva Investigational Site 58332
Lviv, Ukraine
Teva Investigational Site 58322
Uzhhorod, Ukraine
Teva Investigational Site 58330
Vinnytsia, Ukraine
Teva Investigational Site 58331
Vinnytsia, Ukraine
Teva Investigational Site 34305
London, United Kingdom