Phase
Condition
Inflammatory Bowel Disease
Crohn's Disease
Treatment
TEV-48574
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 toparticipate in, and comply with, the requirements of the study
The participant is able to understand the nature of the study and any potentialhazards associated with participating in the study
Women of non-childbearing potential who are either surgically (documentedhysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or congenitallysterile 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 firstinvestigational medicinal product (IMP) administration and throughout the study oruntil 50 days after the last IMP dose, whichever is longer
NOTE- Additional criteria apply, please contact the investigator for more information
Exclusion
Exclusion Criteria:
The participant has any concomitant conditions or treatments that could interferewith study conduct, influence the interpretation of study observations/results, orput the participant at increased risk during the study as judged by the investigatorand/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 sclerosingcholangitis, known non-passable colonic stricture, presence of colonic or smallbowel stoma, presence of non-passable colonic or small bowel obstruction orresection preventing the endoscopy procedure, or fulminant colitis
Presence of active enteric infections (positive stool culture) or a history ofserious infection (requiring parenteral antibiotic and/or hospitalization) within 4weeks 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/orHepatitis C antibody positive with detectable ribonucleic acids, or positive humanimmunodeficiency virus types 1 or 2 at screening.
A history of an opportunistic infection (eg, cytomegalovirus retinitis, Pneumocystiscarinii, or aspergillosis)
A history of more than 2 herpes zoster episode in the last 5 years or multimetamericherpes 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 pregnantor to lactate during the study or for at least 50 days after administration of thelast dose of IMP in case of early termination. Any woman becoming pregnant duringthe 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 orin situ carcinoma of the cervix if successful curative therapy occurred at least 12months prior to screening) or curatively resected papillary thyroid cance
Current or history (within 2 years) of serious psychiatric disease or alcohol ordrug abuse
Participants with incurable diseases, persons in nursing homes, and participantsincapable of giving written informed consent
NOTE- Additional criteria apply, please contact the investigator for more information
Study Design
Connect with a study center
Teva Investigational Site 33055
Innsbruck, 6020
AustriaSite Not Available
Teva Investigational Site 33056
Vienna, 1090
AustriaSite Not Available
Teva Investigational Site 37134
Edegem, 2650
BelgiumSite Not Available
Teva Investigational Site 37133
Liege, 4000
BelgiumSite Not Available
Teva Investigational Site 59200
Blagoevgrad, 2700
BulgariaSite Not Available
Teva Investigational Site 59243
Gorna Oryahovitsa, 5100
BulgariaSite Not Available
Teva Investigational Site 59198
Pleven, 5803
BulgariaSite Not Available
Teva Investigational Site 59196
Sofia, 1784
BulgariaSite Not Available
Teva Investigational Site 59197
Sofia, 1618
BulgariaSite Not Available
Teva Investigational Site 59199
Sofia, 1680
BulgariaSite Not Available
Teva Investigational Site 59244
Varna, 9020
BulgariaSite Not Available
Teva Investigational Site 11257
Winnipeg, Manitoba R3A 1R9
CanadaSite Not Available
Teva Investigational Site 11259
Toronto, Ontario M5T 3A9 , 601
CanadaSite Not Available
Teva Investigational Site 54221
Brno, 615 00
CzechiaSite Not Available
Teva Investigational Site 54222
Klatovy, 339 01
CzechiaSite Not Available
Teva Investigational Site 54241
Prague, 140 00
CzechiaSite Not Available
Teva Investigational Site 54220
Slany, 274 01
CzechiaSite Not Available
Teva Investigational Site 54242
Zabreh, 78901
CzechiaSite Not Available
Teva Investigational Site 35280
Caen, 14033
FranceSite Not Available
Teva Investigational Site 35280
Caen cedex, 14033
FranceSite Not Available
Teva Investigational Site 35295
Nantes, 44300
FranceSite Not Available
Teva Investigational Site 35277
Nice, 06200
FranceSite Not Available
Teva Investigational Site 35277
Nice Cedex 3, 06200
FranceSite Not Available
Teva Investigational Site 35279
Saint Etienne, 42055
FranceSite Not Available
Teva Investigational Site 35279
Saint-Priest-en-Jarez, 42055
FranceSite Not Available
Teva Investigational Site 81052
Tbilisi, 0119
GeorgiaSite Not Available
Teva Investigational Site 81053
Tbilisi, 0180
GeorgiaSite Not Available
Teva Investigational Site 81054
Tbilisi, 0160
GeorgiaSite Not Available
Teva Investigational Site 81055
Tbilisi, 0180
GeorgiaSite Not Available
Teva Investigational Site 81056
Tbilisi, 0178
GeorgiaSite Not Available
Teva Investigational Site 81057
Tbilisi, 0102
GeorgiaSite Not Available
Teva Investigational Site 81058
Tbilisi, 0159
GeorgiaSite Not Available
Teva Investigational Site 32796
Berlin, 10318
GermanySite Not Available
Teva Investigational Site 32872
Berlin, 12559
GermanySite Not Available
Teva Investigational Site 32873
Duisburg, 47055
GermanySite Not Available
Teva Investigational Site 32793
Kiel, 24105
GermanySite Not Available
Teva Investigational Site 32797
Leipzig, 04103
GermanySite Not Available
Teva Investigational Site 32795
Tuebingen, 72076
GermanySite Not Available
Teva Investigational Site 32794
Ulm, 89081
GermanySite Not Available
Teva Investigational Site 32874
Wipperfuerth, 51688
GermanySite Not Available
Teva Investigational Site 51334
Budapest, 1085
HungarySite Not Available
Teva Investigational Site 51335
Budapest, H-1033
HungarySite Not Available
Teva Investigational Site 51336
Gyongyos, 3200
HungarySite Not Available
Teva Investigational Site 51333
Szekesfehervar, H-8000
HungarySite Not Available
Teva Investigational Site 51338
Vac, H-2600
HungarySite Not Available
Teva Investigational Site 80179
Afula, 1834111
IsraelSite Not Available
Teva Investigational Site 80191
Beer Sheva, 8410101
IsraelSite Not Available
Teva Investigational Site 80191
Beer-Sheva, 8410101
IsraelSite Not Available
Teva Investigational Site 80184
Holon, 58100
IsraelSite Not Available
Teva Investigational Site 80182
Kfar Saba, 4428164
IsraelSite Not Available
Teva Investigational Site 80182
Kfar-Sava, 4428164
IsraelSite Not Available
Teva Investigational Site 80180
Rechovot, 761001
IsraelSite Not Available
Teva Investigational Site 80180
Rehovot, 7661041
IsraelSite Not Available
Teva Investigational Site 30304
Brescia, 25123
ItalySite Not Available
Teva Investigational Site 30285
Milan, 20132
ItalySite Not Available
Teva Investigational Site 30286
Milan, 20157
ItalySite Not Available
Teva Investigational Site 30284
Rozzano, 20089
ItalySite Not Available
Teva Investigational Site 30303
San Donato Milanese, 20097
ItalySite Not Available
Teva Investigational Site 30300
San Giovanni Rotondo, 71013
ItalySite Not Available
Teva Investigational Site 30301
Turin, 10128
ItalySite Not Available
Teva Investigational Site 84114
Chiba, 285-8741
JapanSite Not Available
Teva Investigational Site 84112
Fukuoka, 814-0180
JapanSite Not Available
Teva Investigational Site 84112
Fukuoka-shi, 814-0180
JapanSite Not Available
Teva Investigational Site 84110
Kashiwa-shi, 277-0871
JapanSite Not Available
Teva Investigational Site 84117
Minato-ku, 108-8642
JapanSite Not Available
Teva Investigational Site 84115
Mitaka-shi, 181-8611
JapanSite Not Available
Teva Investigational Site 84118
Nagoya, 457-8511
JapanSite Not Available
Teva Investigational Site 84118
Nagoya-shi, 457-8511
JapanSite Not Available
Teva Investigational Site 84113
Osaka, 530-0011
JapanSite Not Available
Teva Investigational Site 84113
Osaka-shi, 530-0011
JapanSite Not Available
Teva Investigational Site 84114
Sakura-shi, 285-8741
JapanSite Not Available
Teva Investigational Site 84116
Shinjuku-ku, 169-0073
JapanSite Not Available
Teva Investigational Site 84115
Tokyo, 181-8611
JapanSite Not Available
Teva Investigational Site 84116
Tokyo, 169-0073
JapanSite Not Available
Teva Investigational Site 84117
Tokyo, 108-8642
JapanSite Not Available
Teva Investigational Site 84111
Toyama, 930-8550
JapanSite Not Available
Teva Investigational Site 84111
Toyama-shi, 930-8550
JapanSite Not Available
Teva Investigational Site 70012
Chisinau, 2005
Moldova, Republic ofSite Not Available
Teva Investigational Site 70013
Chisinau, MD-2025
Moldova, Republic ofSite Not Available
Teva Investigational Site 70014
Chisinau, MD-2025
Moldova, Republic ofSite Not Available
Teva Investigational Site 41015
L?renskog, 1478
NorwaySite Not Available
Teva Investigational Site 41015
Lorenskog, 1478
NorwaySite Not Available
Teva Investigational Site 41014
Tromso, 9038
NorwaySite Not Available
Teva Investigational Site 53565
Bydgoszcz, 85-794
PolandSite Not Available
Teva Investigational Site 53542
Czestochowa, 42-202
PolandSite Not Available
Teva Investigational Site 53543
Elblag, 82-300
PolandSite Not Available
Teva Investigational Site 53544
Gdansk, 80-382
PolandSite Not Available
Teva Investigational Site 53545
Gdynia, 81-537
PolandSite Not Available
Teva Investigational Site 53571
Jelenia Gora, 58-500
PolandSite Not Available
Teva Investigational Site 53546
Katowice, 40-040
PolandSite Not Available
Teva Investigational Site 53547
Klodzko, 57-300
PolandSite Not Available
Teva Investigational Site 53512
Krakow, 31-506
PolandSite Not Available
Teva Investigational Site 53548
Krakow, 31-156
PolandSite Not Available
Teva Investigational Site 53560
Krakow, 30-363
PolandSite Not Available
Teva Investigational Site 53511
Leczna, 21-010
PolandSite Not Available
Teva Investigational Site 53514
Lodz, 91-495
PolandSite Not Available
Teva Investigational Site 53515
Lodz, 90-752
PolandSite Not Available
Teva Investigational Site 53518
Nowy Targ, 34-400
PolandSite Not Available
Teva Investigational Site 53559
Opole, 45-819
PolandSite Not Available
Teva Investigational Site 53572
Piotrkow Trybunalski, 97-300
PolandSite Not Available
Teva Investigational Site 53516
Poznan, 60-529
PolandSite Not Available
Teva Investigational Site 53517
Poznan, 60-324
PolandSite Not Available
Teva Investigational Site 53566
Poznan, 60-702
PolandSite Not Available
Teva Investigational Site 53513
Rzeszow, 35-055
PolandSite Not Available
Teva Investigational Site 53550
Sopot, 81-756
PolandSite Not Available
Teva Investigational Site 53551
Staszow, 28-200
PolandSite Not Available
Teva Investigational Site 53508
Szczecin, 71-434
PolandSite Not Available
Teva Investigational Site 53519
Szczecin, 71-685
PolandSite Not Available
Teva Investigational Site 53552
Tarnow, 33-100
PolandSite Not Available
Teva Investigational Site 53573
Tarnow, 33-100
PolandSite Not Available
Teva Investigational Site 53553
Torun, 87-100
PolandSite Not Available
Teva Investigational Site 53554
Wadowice, 34-100
PolandSite Not Available
Teva Investigational Site 53555
Warsaw, 04-501
PolandSite Not Available
Teva Investigational Site 53556
Warsaw, 02-786
PolandSite Not Available
Teva Investigational Site 53557
Warsaw, 00-189
PolandSite Not Available
Teva Investigational Site 53570
Warsaw, 02-672
PolandSite Not Available
Teva Investigational Site 53555
Warszawa, 00-728
PolandSite Not Available
Teva Investigational Site 53510
Wroclaw, 52-416
PolandSite Not Available
Teva Investigational Site 53520
Wroclaw, 53-673
PolandSite Not Available
Teva Investigational Site 53549
Wroclaw, 54-144
PolandSite Not Available
Teva Investigational Site 53558
Wroclaw, 50-381
PolandSite Not Available
Teva Investigational Site 53562
Wroclaw, 53-611
PolandSite Not Available
Teva Investigational Site 53563
Wroclaw, 54-144
PolandSite Not Available
Teva Investigational Site 53567
Wroclaw, 53-149
PolandSite Not Available
Teva Investigational Site 53509
Zamosc, 22-400
PolandSite Not Available
Teva Investigational Site 61055
Belgrade, 11000
SerbiaSite Not Available
Teva Investigational Site 62097
Presov, 8001
SerbiaSite Not Available
Teva Investigational Site 62098
Banska Bystrica, 975 17
SlovakiaSite Not Available
Teva Investigational Site 62074
Bardejov, 085 01
SlovakiaSite Not Available
Teva Investigational Site 62073
Bratislava, 811 09
SlovakiaSite Not Available
Teva Investigational Site 62071
Kosice, 040 13
SlovakiaSite Not Available
Teva Investigational Site 62076
Presov, 080 01
SlovakiaSite Not Available
Teva Investigational Site 62097
Presov, 080 01
SlovakiaSite Not Available
Teva Investigational Site 62099
Rimavska Sobota, 979 01
SlovakiaSite Not Available
Teva Investigational Site 62072
Sahy, 936 01
SlovakiaSite Not Available
Teva Investigational Site 31325
Alicante, 03010
SpainSite Not Available
Teva Investigational Site 31302
Cordoba, 14004
SpainSite Not Available
Teva Investigational Site 31293
Huelva, 21005
SpainSite Not Available
Teva Investigational Site 31301
Las Palmas de Gran Canaria, 35010
SpainSite Not Available
Teva Investigational Site 31318
Santiago de Compostela, 15702
SpainSite Not Available
Teva Investigational Site 31291
Sevilla, 41017
SpainSite Not Available
Teva Investigational Site 31291
Seville, 41009
SpainSite Not Available
Teva Investigational Site 31292
Valencia, 46026
SpainSite Not Available
Teva Investigational Site 58327
Chernivtsi, 58002
UkraineSite Not Available
Teva Investigational Site 58324
Ivano-Frankivsk, 76008
UkraineSite Not Available
Teva Investigational Site 58325
Lviv, 79010
UkraineSite Not Available
Teva Investigational Site 58329
Lviv, 79000
UkraineSite Not Available
Teva Investigational Site 58332
Lviv, 79010
UkraineSite Not Available
Teva Investigational Site 58328
Ternopil, 46002
UkraineSite Not Available
Teva Investigational Site 58322
Uzhgorod, 88018
UkraineActive - Recruiting
Teva Investigational Site 58323
Uzhgorod, 88009
UkraineSite Not Available
Teva Investigational Site 58322
Uzhhorod, 88000
UkraineSite Not Available
Teva Investigational Site 58323
Uzhhorod, 88000
UkraineSite Not Available
Teva Investigational Site 58330
Vinnytsia, 21018
UkraineSite Not Available
Teva Investigational Site 58331
Vinnytsia, 21018
UkraineSite Not Available
Teva Investigational Site 34305
London, SE1 9RT
United KingdomSite Not Available
Teva Investigational Site 15564
Chandler, Arizona 85224
United StatesSite Not Available
Teva Investigational Site 15564
Scottsdale, Arizona 85260
United StatesSite Not Available
Teva Investigational Site 15568
Sun City, Arizona 85351
United StatesSite Not Available
Teva Investigational Site 15556
San Diego, California 92103
United StatesSite Not Available
Teva Investigational Site 15747
San Diego, California 92103
United StatesSite Not Available
Teva Investigational Site 15357
Kissimmee, Florida 34741
United StatesSite Not Available
Teva Investigational Site 15365
Miami, Florida 33136
United StatesSite Not Available
Teva Investigational Site 15563
Miami, Florida 33032
United StatesSite Not Available
Teva Investigational Site 15748
Miami, Florida 33176
United StatesSite Not Available
Teva Investigational Site 15375
Orlando, Florida 32803
United StatesSite Not Available
Teva Investigational Site 15359
Pinellas Park, Florida 33781
United StatesSite Not Available
Teva Investigational Site 15359
Tampa, Florida 33626
United StatesSite Not Available
Teva Investigational Site 15566
Glenview, Illinois 60026
United StatesSite Not Available
Teva Investigational Site 15567
Gurnee, Illinois 60031
United StatesSite Not Available
Teva Investigational Site 15574
New Albany, Indiana 47150
United StatesSite Not Available
Teva Investigational Site 15575
New Albany, Indiana 47150
United StatesActive - Recruiting
Teva Investigational Site 15362
Iowa City, Iowa 52242
United StatesSite Not Available
Teva Investigational Site 15367
Kansas City, Kansas 66160
United StatesSite Not Available
Teva Investigational Site 15358
Leawood, Kansas 66214
United StatesSite Not Available
Teva Investigational Site 15368
Louisville, Kentucky 40202
United StatesSite Not Available
Teva Investigational Site 15575
Louisville, Kentucky 40218
United StatesSite Not Available
Teva Investigational Site 15363
Columbia, Maryland 21045
United StatesSite Not Available
Teva Investigational Site 15744
Tupelo, Mississippi 38801
United StatesSite Not Available
Teva Investigational Site 15358
Liberty, Missouri 64068
United StatesSite Not Available
Teva Investigational Site 15373
Saint Louis, Missouri 63110
United StatesSite Not Available
Teva Investigational Site 15369
Las Vegas, Nevada 89128.
United StatesSite Not Available
Teva Investigational Site 15558
North Massapequa, New York 11758
United StatesSite Not Available
Teva Investigational Site 15370
Chapel Hill, North Carolina 27514
United StatesSite Not Available
Teva Investigational Site 15750
Beavercreek, Ohio 45440
United StatesSite Not Available
Teva Investigational Site 15750
Dayton, Ohio 45415
United StatesSite Not Available
Teva Investigational Site 15557
Greenville, South Carolina 29615
United StatesSite Not Available
Teva Investigational Site 15573
Cordova, Tennessee 38018
United StatesSite Not Available
Teva Investigational Site 15360
Austin, Texas 78748
United StatesSite Not Available
Teva Investigational Site 15371
Dallas, Texas 75246
United StatesSite Not Available
Teva Investigational Site 15751
Dallas, Texas 75246
United StatesSite Not Available
Teva Investigational Site 15569
Garland, Texas 75044
United StatesSite Not Available
Teva Investigational Site 15559
Harlingen, Texas 78550
United StatesSite Not Available
Teva Investigational Site 15366
Katy, Texas 77494
United StatesSite Not Available
Teva Investigational Site 15743
Lubbock, Texas 79424
United StatesSite Not Available
Teva Investigational Site 15372
Pearland, Texas 77584
United StatesSite Not Available
Teva Investigational Site 15374
San Antonio, Texas 78229
United StatesSite Not Available
Teva Investigational Site 15565
Southlake, Texas 76092
United StatesSite Not Available
Teva Investigational Site 15567
Southlake, Texas 76092
United StatesActive - Recruiting
Teva Investigational Site 15568
Southlake, Texas 76092
United StatesSite Not Available
Teva Investigational Site 15361
Tyler, Texas 75701
United StatesSite Not Available
Teva Investigational Site 15364
Salt Lake City, Utah 84124
United StatesSite Not Available
Teva Investigational Site 15560
Vancouver, Washington 98664
United StatesSite Not Available
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