Clinical trial NCT05499130: A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
Official title: A 14 Week Phase 2b, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Efficacy, Safety and Tolerability of TEV-48574 in Adult Patients With Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn Disease
Colitis, Ulcerative
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2022-08-12
Enrollment: 290
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 is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14.

Secondary objectives:

* To evaluate the efficacy and dose response of the 2 different dose regimens as assessed by multiple standard measures
* To evaluate the safety and tolerability of the 2 different dose regimens
* To evaluate the immunogenicity of the 2 different dose regimens

The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for ≥3 months
* The participant is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study
* The participant is able to understand the nature of the study and any potential hazards associated with participating in the study
* Women of non-childbearing potential who are either surgically (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or congenitally sterile as assessed by a physician, or 1-year postmenopausal
* Male participants (including vasectomized) with women of childbearing potential (WOCBP) partners (whether pregnant or not) must use condoms after the first investigational medicinal product (IMP) administration and throughout the study or until 50 days after the last IMP dose, whichever is longer

NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* The 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
* Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic coliti
* Participant has colonic dysplasia or neoplasia, toxic megacolon, primary sclerosing cholangitis, known non-passable colonic stricture, presence of colonic or small bowel stoma, presence of non-passable colonic or small bowel obstruction or resection preventing the endoscopy procedure, or fulminant colitis
* Presence of active enteric infections (positive stool culture) or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks prior to the first screening visit
* Participant anticipates requiring major surgery during this study.
* A participant is Hepatitis B core antibody or surface antigen positive and/or Hepatitis C antibody positive with detectable ribonucleic acids, or positive human immunodeficiency virus types 1 or 2 at screening.
* A history of an opportunistic infection (eg, cytomegalovirus retinitis, Pneumocystis carinii, or aspergillosis)
* A history of more than 2 herpes zoster episode in the last 5 years or multimetameric herpes zoster
* A history of or ongoing chronic or recurrent serious infectious disease (eg, infected indwelling prosthesis or osteomyelitis)
* The 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.
* Presence of a transplanted organ
* A history of malignancy within the last 5 years (exception: basal cell carcinoma or in situ carcinoma of the cervix if successful curative therapy occurred at least 12 months prior to screening) or curatively resected papillary thyroid cance
* Current or history (within 2 years) of serious psychiatric disease or alcohol or drug abuse
* Participants with incurable diseases, persons in nursing homes, and participants incapable of giving written informed consent

NOTE- Additional criteria apply, please contact the investigator for more information

Primary outcomes:
measure: Number of participants with moderate to severe UC who show clinical remission as defined by the Mayo score
timeFrame: Week 14
measure: Number of participants with moderate to severe CD who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease
timeFrame: Week 14
Secondary outcomes:
measure: Number of participants with moderate to severe UC with a clinical response as defined by a decrease from baseline in Mayo score
timeFrame: Baseline and Week 14
measure: Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score
timeFrame: Week 14
measure: Number of participants with moderate to severe UC in Endoscopic remission as defined by Mayo score
timeFrame: Week 14
measure: Number of participants with moderate to severe UC with a clinical response as defined as a decrease from baseline in 2-item patient-reported outcome (PRO2)
timeFrame: Baseline and Week 14
measure: Number of participants with moderate to severe UC in Clinical remission as defined by PRO2 score
timeFrame: Week 14
measure: Number of participants with moderate to severe CD with a clinical response with a decrease from baseline in Crohn's Disease Activity Index (CDAI)
timeFrame: Baseline, Weeks 4, 8, 12 and 14
measure: Number of participants with moderate to severe CD in clinical remission as defined by CDAI score
timeFrame: Week 14
measure: Number of participants with moderate to severe CD with a clinical response as defined by PRO2 score
timeFrame: Baseline and Week 14
measure: Number of participants with moderate to severe CD in clinical remission as defined by PRO2 score
timeFrame: Week 14
measure: Number of participants with moderate to severe CD with an Endoscopic response as defined by the Modified Multiplier-Simple Endoscopic Score (MM-SES-CD)
timeFrame: Baseline and Week 14
measure: Number of Participants Who Experience Adverse Events
timeFrame: Baseline up to Week 18
measure: Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events
timeFrame: Up to Week 18
measure: Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADA)
timeFrame: Baseline, Weeks 2, 4, 8, 14, and 18
measure: Number of ADA positive participants with the presence of neutralizing ADA
timeFrame: Weeks 2, 4, 8, 14, and 18
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Teva Investigational Site 15568
state: Arizona
city: San Diego
country: United States
facility: Teva Investigational Site 15556
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 15747
state: California
city: Kissimmee
country: United States
facility: Teva Investigational Site 15357
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15563
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15365
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15748
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: Glenview
country: United States
facility: Teva Investigational Site 15566
state: Illinois
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: Iowa City
country: United States
facility: Teva Investigational Site 15362
state: Iowa
city: Kansas City
country: United States
facility: Teva Investigational Site 15367
state: Kansas
city: Louisville
country: United States
facility: Teva Investigational Site 15368
state: Kentucky
city: Louisville
country: United States
facility: Teva Investigational Site 15575
state: Kentucky
city: Columbia
country: United States
facility: Teva Investigational Site 15363
state: Maryland
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: North Massapequa
country: United States
facility: Teva Investigational Site 15558
state: New York
city: Chapel Hill
country: United States
facility: Teva Investigational Site 15370
state: North Carolina
city: Beavercreek
country: United States
facility: Teva Investigational Site 15750
state: Ohio
city: Greenville
country: United States
facility: Teva Investigational Site 15557
state: South Carolina
city: Cordova
country: United States
facility: Teva Investigational Site 15573
state: Tennessee
city: Austin
country: United States
facility: Teva Investigational Site 15360
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 15371
state: Texas
city: Garland
country: United States
facility: Teva Investigational Site 15569
state: Texas
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: Lubbock
country: United States
facility: Teva Investigational Site 15743
state: Texas
city: Pearland
country: United States
facility: Teva Investigational Site 15372
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: Innsbruck
country: Austria
facility: Teva Investigational Site 33055
city: Vienna
country: Austria
facility: Teva Investigational Site 33056
city: Edegem
country: Belgium
facility: Teva Investigational Site 37134
city: Liege
country: Belgium
facility: Teva Investigational Site 37133
city: Gorna Oryahovitsa
country: Bulgaria
facility: Teva Investigational Site 59243
city: Pleven
country: Bulgaria
facility: Teva Investigational Site 59198
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59197
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59199
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59196
city: Winnipeg
country: Canada
facility: Teva Investigational Site 11257
state: Manitoba
city: Brno
country: Czechia
facility: Teva Investigational Site 54221
city: Klatovy
country: Czechia
facility: Teva Investigational Site 54222
city: Prague
country: Czechia
facility: Teva Investigational Site 54241
city: Slany
country: Czechia
facility: Teva Investigational Site 54220
city: Zabreh
country: Czechia
facility: Teva Investigational Site 54242
city: Caen
country: France
facility: Teva Investigational Site 35280
city: Nantes
country: France
facility: Teva Investigational Site 35295
city: Nice
country: France
facility: Teva Investigational Site 35277
city: Saint-Priest-en-Jarez
country: France
facility: Teva Investigational Site 35279
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81057
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81052
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81054
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81056
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81053
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81055
city: Berlin
country: Germany
facility: Teva Investigational Site 32796
city: Berlin
country: Germany
facility: Teva Investigational Site 32872
city: Duisburg
country: Germany
facility: Teva Investigational Site 32873
city: Kiel
country: Germany
facility: Teva Investigational Site 32793
city: Leipzig
country: Germany
facility: Teva Investigational Site 32797
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: Gyongyos
country: Hungary
facility: Teva Investigational Site 51336
city: Szekesfehervar
country: Hungary
facility: Teva Investigational Site 51333
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: Holon
country: Israel
facility: Teva Investigational Site 80184
city: Kfar Saba
country: Israel
facility: Teva Investigational Site 80182
city: Rehovot
country: Israel
facility: Teva Investigational Site 80180
city: Brescia
country: Italy
facility: Teva Investigational Site 30304
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: San Donato Milanese
country: Italy
facility: Teva Investigational Site 30303
city: San Giovanni Rotondo
country: Italy
facility: Teva Investigational Site 30300
city: Turin
country: Italy
facility: Teva Investigational Site 30301
city: Chiba
country: Japan
facility: Teva Investigational Site 84114
city: Fukuoka
country: Japan
facility: Teva Investigational Site 84112
city: Kashiwa-shi
country: Japan
facility: Teva Investigational Site 84110
city: Nagoya
country: Japan
facility: Teva Investigational Site 84118
city: Osaka
country: Japan
facility: Teva Investigational Site 84113
city: Tokyo
country: Japan
facility: Teva Investigational Site 84117
city: Tokyo
country: Japan
facility: Teva Investigational Site 84116
city: Tokyo
country: Japan
facility: Teva Investigational Site 84115
city: Toyama
country: Japan
facility: Teva Investigational Site 84111
city: Lorenskog
country: Norway
facility: Teva Investigational Site 41015
city: Tromso
country: Norway
facility: Teva Investigational Site 41014
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: Gdynia
country: Poland
facility: Teva Investigational Site 53545
city: Jelenia Gora
country: Poland
facility: Teva Investigational Site 53571
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: Lodz
country: Poland
facility: Teva Investigational Site 53514
city: Nowy Targ
country: Poland
facility: Teva Investigational Site 53518
city: Opole
country: Poland
facility: Teva Investigational Site 53559
city: Piotrkow Trybunalski
country: Poland
facility: Teva Investigational Site 53572
city: Poznan
country: Poland
facility: Teva Investigational Site 53517
city: Poznan
country: Poland
facility: Teva Investigational Site 53516
city: Poznan
country: Poland
facility: Teva Investigational Site 53566
city: Rzeszow
country: Poland
facility: Teva Investigational Site 53513
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: Tarnow
country: Poland
facility: Teva Investigational Site 53552
city: Tarnow
country: Poland
facility: Teva Investigational Site 53573
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 53558
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: Banska Bystrica
country: Slovakia
facility: Teva Investigational Site 62098
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: Rimavska Sobota
country: Slovakia
facility: Teva Investigational Site 62099
city: Sahy
country: Slovakia
facility: Teva Investigational Site 62072
city: Alicante
country: Spain
facility: Teva Investigational Site 31325
city: Cordoba
country: Spain
facility: Teva Investigational Site 31302
city: Huelva
country: Spain
facility: Teva Investigational Site 31293
city: Las Palmas de Gran Canaria
country: Spain
facility: Teva Investigational Site 31301
city: Santiago de Compostela
country: Spain
facility: Teva Investigational Site 31318
city: Seville
country: Spain
facility: Teva Investigational Site 31291
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: Ternopil
country: Ukraine
facility: Teva Investigational Site 58328
city: Uzhhorod
country: Ukraine
facility: Teva Investigational Site 58322
city: Uzhhorod
country: Ukraine
facility: Teva Investigational Site 58323
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: