A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
- Conditions
- Colitis, UlcerativeCrohn Disease
- Interventions
- Drug: TEV-48574 Dose Regimen ADrug: TEV-48574 Dose Regiment B
- Registration Number
- NCT05668013
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 218
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TEV-48574 Dose Regimen A for Ulcerative Colitis (UC) TEV-48574 Dose Regimen A Administered by subcutaneous infusion for participants with UC TEV-48574 Dose Regimen A for Crohn's Disease (CD) TEV-48574 Dose Regimen A Administered by subcutaneous infusion for participants with CD TEV-48574 Dose Regimen B for Ulcerative Colitis (UC) TEV-48574 Dose Regiment B Administered by subcutaneous infusion for participants with UC TEV-48574 Dose Regimen B for Crohn's Disease (CD) TEV-48574 Dose Regiment B Administered by subcutaneous infusion for participants with CD
- Primary Outcome Measures
Name Time Method Number of participants with moderate to severe ulcerative colitis (UC) who show clinical remission as defined by the Mayo score Week 44 Clinical remission based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points, which is defined by:
* stool frequency subscore of 0 or 1,
* rectal bleeding subscore of 0, and
* endoscopic subscore of 0 or 1, where a score of 1 does not include "friability"Number of participants with moderate to severe Crohn's disease (CD) who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease Week 44 Endoscopic response, defined as a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 50% from DRF study baseline at week 44 in participants with CD
- Secondary Outcome Measures
Name Time Method Number of participants with moderate to severe CD with a clinical response based on Crohn's Disease Activity Index Week 44 Clinical response defined as a ≥100-point decrease from DRF baseline Crohn's Disease Activity Index (CDAI) score
Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score Week 44 Endoscopic improvement defined as a Mayo endoscopic subscore of 0 or 1
Number of participants with moderate to severe CD in clinical remission as defined by CDAI score Week 44 Clinical remission defined as a CDAI score less than 150
Number of participants who experience adverse events in the double-blind period Up to Week 48 Adverse events can include any of the following clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), 12-lead electrocardiogram (ECG), and injection site reactions.
Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events in the open-label (OL) period Up to 5 years after start of OL period Number of participants with moderate to severe UC with Corticosteroid-free clinical remission based on the modified Mayo score Week 44 Defined by clinical remission and corticosteroid-free for ≥12 weeks preceding week 44
Number of participants with moderate to severe CD with Corticosteroid-free endoscopic response based on SES-CD Week 44 Defined by endoscopic response and corticosteroid-free for ≥12 weeks preceding week 44
Number of participants with treatment emergent Anti-Drug Antibodies (ADA) Weeks 0, 4, 8, 16, 28, 44, and 48 Number of participants with moderate to severe UC with a clinical response as defined by Mayo score Week 44 Clinical response at week 44, defined as a decrease from baseline in the modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of at least 2 points AND at least a 30% reduction from DRF baseline with either a decrease in rectal bleeding subscore of at least 1 or an absolute rectal bleeding subscore of less than or equal to 1
Number of participants with moderate to severe UC in Endoscopic remission as defined by Mayo score Week 44 Endoscopic remission defined as a Mayo endoscopic subscore of 0
Number of participants who experience adverse events in the open-label (OL) period Up to 5 years after start of OL period Adverse events can include any of the following clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), 12-lead electrocardiogram (ECG), and injection site reactions.
Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events in the double-blind period Up to Week 48 Number of participants with moderate to severe CD with Corticosteroid-free clinical remission based on CDAI Week 44 Defined by a CDAI score of \<150 points and corticosteroid-free for ≥12 weeks preceding week 44
Number of ADA positive participants with the presence of neutralizing ADA Weeks 0, 4, 8, 16, 28, 44, and 48
Trial Locations
- 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
🇺🇸Saint 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
🇨🇿Slany, Czechia
Teva Investigational Site 81053
🇬🇪Tbilisi, Georgia
Teva Investigational Site 81052
🇬🇪Tbilisi, Georgia
Teva Investigational Site 32793
🇩🇪Kiel, Germany
Teva Investigational Site 32795
🇩🇪Tuebingen, Germany
Teva Investigational Site 32794
🇩🇪Ulm, Germany
Teva Investigational Site 32874
🇩🇪Wipperfuerth, Germany
Teva Investigational Site 51334
🇭🇺Budapest, Hungary
Teva Investigational Site 51335
🇭🇺Budapest, Hungary
Teva Investigational Site 51338
🇭🇺Vac, Hungary
Teva Investigational Site 80179
🇮🇱Afula, Israel
Teva Investigational Site 80191
🇮🇱Beer-Sheva, Israel
Teva Investigational Site 30285
🇮🇹Milan, Italy
Teva Investigational Site 30286
🇮🇹Milan, Italy
Teva Investigational Site 30284
🇮🇹Rozzano, Italy
Teva Investigational Site 84114
🇯🇵Chiba, Japan
Teva Investigational Site 84110
🇯🇵Kashiwa-shi, Japan
Teva Investigational Site 84117
🇯🇵Tokyo, Japan
Teva Investigational Site 84116
🇯🇵Tokyo, Japan
Teva Investigational Site 84111
🇯🇵Toyama, Japan
Teva Investigational Site 41015
🇳🇴Lorenskog, Norway
Teva Investigational Site 53565
🇵🇱Bydgoszcz, Poland
Teva Investigational Site 53542
🇵🇱Czestochowa, Poland
Teva Investigational Site 53543
🇵🇱Elblag, Poland
Teva Investigational Site 53544
🇵🇱Gdansk, Poland
Teva Investigational Site 53546
🇵🇱Katowice, Poland
Teva Investigational Site 53547
🇵🇱Klodzko, Poland
Teva Investigational Site 53560
🇵🇱Krakow, Poland
Teva Investigational Site 53548
🇵🇱Krakow, Poland
Teva Investigational Site 53512
🇵🇱Krakow, Poland
Teva Investigational Site 53511
🇵🇱Leczna, Poland
Teva Investigational Site 53515
🇵🇱Lodz, Poland
Teva Investigational Site 53518
🇵🇱Nowy Targ, Poland
Teva Investigational Site 53516
🇵🇱Poznan, Poland
Teva Investigational Site 53566
🇵🇱Poznan, Poland
Teva Investigational Site 53550
🇵🇱Sopot, Poland
Teva Investigational Site 53551
🇵🇱Staszow, 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 53562
🇵🇱Wroclaw, Poland
Teva Investigational Site 53510
🇵🇱Wroclaw, Poland
Teva Investigational Site 53567
🇵🇱Wroclaw, Poland
Teva Investigational Site 53520
🇵🇱Wroclaw, Poland
Teva Investigational Site 53549
🇵🇱Wroclaw, Poland
Teva Investigational Site 53563
🇵🇱Wroclaw, Poland
Teva Investigational Site 53509
🇵🇱Zamosc, Poland
Teva Investigational Site 62074
🇸🇰Bardejov, Slovakia
Teva Investigational Site 62073
🇸🇰Bratislava, Slovakia
Teva Investigational Site 62071
🇸🇰Kosice, Slovakia
Teva Investigational Site 62076
🇸🇰Presov, Slovakia
Teva Investigational Site 62097
🇸🇰Presov, 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
Related News
Teva and Sanofi Announce Duvakitug (Anti-TL1A) Positive Phase 2b Results Demonstrating ...
- Prev
- 1
- Next