Clinical trial NCT05668013: A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Crohn Disease
Colitis, Ulcerative
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2022-12-29
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of participants with moderate to severe ulcerative colitis (UC) who show clinical remission as defined by the Mayo score
timeFrame: Week 44
measure: 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
timeFrame: Week 44
Secondary outcomes:
measure: Number of participants with moderate to severe UC with a clinical response as defined by Mayo score
timeFrame: Week 44
measure: Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score
timeFrame: Week 44
measure: Number of participants with moderate to severe UC in Endoscopic remission as defined by Mayo score
timeFrame: Week 44
measure: Number of participants with moderate to severe UC with Corticosteroid-free clinical remission based on the modified Mayo score
timeFrame: Week 44
measure: Number of participants with moderate to severe CD with a clinical response based on Crohn's Disease Activity Index
timeFrame: Week 44
measure: Number of participants with moderate to severe CD in clinical remission as defined by CDAI score
timeFrame: Week 44
measure: Number of participants with moderate to severe CD with Corticosteroid-free endoscopic response based on SES-CD
timeFrame: Week 44
measure: Number of participants with moderate to severe CD with Corticosteroid-free clinical remission based on CDAI
timeFrame: Week 44
measure: Number of participants who experience adverse events in the double-blind period
timeFrame: Up to Week 48
measure: Number of participants who experience adverse events in the open-label (OL) period
timeFrame: Up to 5 years after start of OL period
measure: Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events in the double-blind period
timeFrame: Up to Week 48
measure: Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events in the open-label (OL) period
timeFrame: Up to 5 years after start of OL period
measure: Number of participants with treatment emergent Anti-Drug Antibodies (ADA)
timeFrame: Weeks 0, 4, 8, 16, 28, 44, and 48
measure: Number of ADA positive participants with the presence of neutralizing ADA
timeFrame: Weeks 0, 4, 8, 16, 28, 44, and 48
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Teva Investigational Site 15556
state: California
city: Kissimmee
country: United States
facility: Teva Investigational Site 15357
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 15375
state: Florida
city: Pinellas Park
country: United States
facility: Teva Investigational Site 15359
state: Florida
city: Gurnee
country: United States
facility: Teva Investigational Site 15567
state: Illinois
city: New Albany
country: United States
facility: Teva Investigational Site 15574
state: Indiana
city: Kansas City
country: United States
facility: Teva Investigational Site 15367
state: Kansas
city: Louisville
country: United States
facility: Teva Investigational Site 15575
state: Kentucky
city: Liberty
country: United States
facility: Teva Investigational Site 15358
state: Missouri
city: Saint Louis
country: United States
facility: Teva Investigational Site 15373
state: Missouri
city: Las Vegas
country: United States
facility: Teva Investigational Site 15369
state: Nevada
city: Beavercreek
country: United States
facility: Teva Investigational Site 15750
state: Ohio
city: Harlingen
country: United States
facility: Teva Investigational Site 15559
state: Texas
city: Katy
country: United States
facility: Teva Investigational Site 15366
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 15374
state: Texas
city: Southlake
country: United States
facility: Teva Investigational Site 15565
state: Texas
city: Tyler
country: United States
facility: Teva Investigational Site 15361
state: Texas
city: Salt Lake City
country: United States
facility: Teva Investigational Site 15364
state: Utah
city: Vienna
country: Austria
facility: Teva Investigational Site 33056
city: Gorna Oryahovitsa
country: Bulgaria
facility: Teva Investigational Site 59243
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59197
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59196
city: Brno
country: Czechia
facility: Teva Investigational Site 54221
city: Klatovy
country: Czechia
facility: Teva Investigational Site 54222
city: Slany
country: Czechia
facility: Teva Investigational Site 54220
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81052
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81053
city: Kiel
country: Germany
facility: Teva Investigational Site 32793
city: Tuebingen
country: Germany
facility: Teva Investigational Site 32795
city: Ulm
country: Germany
facility: Teva Investigational Site 32794
city: Wipperfuerth
country: Germany
facility: Teva Investigational Site 32874
city: Budapest
country: Hungary
facility: Teva Investigational Site 51334
city: Budapest
country: Hungary
facility: Teva Investigational Site 51335
city: Vac
country: Hungary
facility: Teva Investigational Site 51338
city: Afula
country: Israel
facility: Teva Investigational Site 80179
city: Beer-Sheva
country: Israel
facility: Teva Investigational Site 80191
city: Milan
country: Italy
facility: Teva Investigational Site 30285
city: Milan
country: Italy
facility: Teva Investigational Site 30286
city: Rozzano
country: Italy
facility: Teva Investigational Site 30284
city: Chiba
country: Japan
facility: Teva Investigational Site 84114
city: Kashiwa-shi
country: Japan
facility: Teva Investigational Site 84110
city: Tokyo
country: Japan
facility: Teva Investigational Site 84117
city: Tokyo
country: Japan
facility: Teva Investigational Site 84116
city: Toyama
country: Japan
facility: Teva Investigational Site 84111
city: Lorenskog
country: Norway
facility: Teva Investigational Site 41015
city: Bydgoszcz
country: Poland
facility: Teva Investigational Site 53565
city: Czestochowa
country: Poland
facility: Teva Investigational Site 53542
city: Elblag
country: Poland
facility: Teva Investigational Site 53543
city: Gdansk
country: Poland
facility: Teva Investigational Site 53544
city: Katowice
country: Poland
facility: Teva Investigational Site 53546
city: Klodzko
country: Poland
facility: Teva Investigational Site 53547
city: Krakow
country: Poland
facility: Teva Investigational Site 53560
city: Krakow
country: Poland
facility: Teva Investigational Site 53548
city: Krakow
country: Poland
facility: Teva Investigational Site 53512
city: Leczna
country: Poland
facility: Teva Investigational Site 53511
city: Lodz
country: Poland
facility: Teva Investigational Site 53515
city: Nowy Targ
country: Poland
facility: Teva Investigational Site 53518
city: Poznan
country: Poland
facility: Teva Investigational Site 53516
city: Poznan
country: Poland
facility: Teva Investigational Site 53566
city: Sopot
country: Poland
facility: Teva Investigational Site 53550
city: Staszow
country: Poland
facility: Teva Investigational Site 53551
city: Szczecin
country: Poland
facility: Teva Investigational Site 53508
city: Szczecin
country: Poland
facility: Teva Investigational Site 53519
city: Torun
country: Poland
facility: Teva Investigational Site 53553
city: Wadowice
country: Poland
facility: Teva Investigational Site 53554
city: Warsaw
country: Poland
facility: Teva Investigational Site 53557
city: Warsaw
country: Poland
facility: Teva Investigational Site 53570
city: Warsaw
country: Poland
facility: Teva Investigational Site 53556
city: Warsaw
country: Poland
facility: Teva Investigational Site 53555
city: Wroclaw
country: Poland
facility: Teva Investigational Site 53510
city: Wroclaw
country: Poland
facility: Teva Investigational Site 53567
city: Wroclaw
country: Poland
facility: Teva Investigational Site 53562
city: Wroclaw
country: Poland
facility: Teva Investigational Site 53520
city: Wroclaw
country: Poland
facility: Teva Investigational Site 53549
city: Wroclaw
country: Poland
facility: Teva Investigational Site 53563
city: Zamosc
country: Poland
facility: Teva Investigational Site 53509
city: Bardejov
country: Slovakia
facility: Teva Investigational Site 62074
city: Bratislava
country: Slovakia
facility: Teva Investigational Site 62073
city: Kosice
country: Slovakia
facility: Teva Investigational Site 62071
city: Presov
country: Slovakia
facility: Teva Investigational Site 62076
city: Presov
country: Slovakia
facility: Teva Investigational Site 62097
city: Huelva
country: Spain
facility: Teva Investigational Site 31293
city: Santiago de Compostela
country: Spain
facility: Teva Investigational Site 31318
city: Valencia
country: Spain
facility: Teva Investigational Site 31292
city: Chernivtsi
country: Ukraine
facility: Teva Investigational Site 58327
city: Ivano-Frankivsk
country: Ukraine
facility: Teva Investigational Site 58324
city: Lviv
country: Ukraine
facility: Teva Investigational Site 58329
city: Lviv
country: Ukraine
facility: Teva Investigational Site 58325
city: Lviv
country: Ukraine
facility: Teva Investigational Site 58332
city: Uzhhorod
country: Ukraine
facility: Teva Investigational Site 58322
city: Vinnytsia
country: Ukraine
facility: Teva Investigational Site 58330
city: Vinnytsia
country: Ukraine
facility: Teva Investigational Site 58331
city: London
country: United Kingdom
facility: Teva Investigational Site 34305
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: