A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

Last updated: March 18, 2025
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Overall Status: Completed

Phase

2

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

TEV-48574

Placebo

Clinical Study ID

NCT05499130
TV48574-IMM-20036
2024-511089-36-00
2021-006881-19
  • Ages 18-75
  • All Genders

Study 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

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

Total Participants: 290
Treatment Group(s): 2
Primary Treatment: TEV-48574
Phase: 2
Study Start date:
August 29, 2022
Estimated Completion Date:
November 12, 2024

Connect with a study center

  • Teva Investigational Site 33055

    Innsbruck, 6020
    Austria

    Site Not Available

  • Teva Investigational Site 33056

    Vienna, 1090
    Austria

    Site Not Available

  • Teva Investigational Site 37134

    Edegem, 2650
    Belgium

    Site Not Available

  • Teva Investigational Site 37133

    Liege, 4000
    Belgium

    Site Not Available

  • Teva Investigational Site 59200

    Blagoevgrad, 2700
    Bulgaria

    Site Not Available

  • Teva Investigational Site 59243

    Gorna Oryahovitsa, 5100
    Bulgaria

    Site Not Available

  • Teva Investigational Site 59198

    Pleven, 5803
    Bulgaria

    Site Not Available

  • Teva Investigational Site 59196

    Sofia, 1784
    Bulgaria

    Site Not Available

  • Teva Investigational Site 59197

    Sofia, 1618
    Bulgaria

    Site Not Available

  • Teva Investigational Site 59199

    Sofia, 1680
    Bulgaria

    Site Not Available

  • Teva Investigational Site 59244

    Varna, 9020
    Bulgaria

    Site Not Available

  • Teva Investigational Site 11257

    Winnipeg, Manitoba R3A 1R9
    Canada

    Site Not Available

  • Teva Investigational Site 11259

    Toronto, Ontario M5T 3A9 , 601
    Canada

    Site Not Available

  • Teva Investigational Site 54221

    Brno, 615 00
    Czechia

    Site Not Available

  • Teva Investigational Site 54222

    Klatovy, 339 01
    Czechia

    Site Not Available

  • Teva Investigational Site 54241

    Prague, 140 00
    Czechia

    Site Not Available

  • Teva Investigational Site 54220

    Slany, 274 01
    Czechia

    Site Not Available

  • Teva Investigational Site 54242

    Zabreh, 78901
    Czechia

    Site Not Available

  • Teva Investigational Site 35280

    Caen, 14033
    France

    Site Not Available

  • Teva Investigational Site 35280

    Caen cedex, 14033
    France

    Site Not Available

  • Teva Investigational Site 35295

    Nantes, 44300
    France

    Site Not Available

  • Teva Investigational Site 35277

    Nice, 06200
    France

    Site Not Available

  • Teva Investigational Site 35277

    Nice Cedex 3, 06200
    France

    Site Not Available

  • Teva Investigational Site 35279

    Saint Etienne, 42055
    France

    Site Not Available

  • Teva Investigational Site 35279

    Saint-Priest-en-Jarez, 42055
    France

    Site Not Available

  • Teva Investigational Site 81052

    Tbilisi, 0119
    Georgia

    Site Not Available

  • Teva Investigational Site 81053

    Tbilisi, 0180
    Georgia

    Site Not Available

  • Teva Investigational Site 81054

    Tbilisi, 0160
    Georgia

    Site Not Available

  • Teva Investigational Site 81055

    Tbilisi, 0180
    Georgia

    Site Not Available

  • Teva Investigational Site 81056

    Tbilisi, 0178
    Georgia

    Site Not Available

  • Teva Investigational Site 81057

    Tbilisi, 0102
    Georgia

    Site Not Available

  • Teva Investigational Site 81058

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Teva Investigational Site 32796

    Berlin, 10318
    Germany

    Site Not Available

  • Teva Investigational Site 32872

    Berlin, 12559
    Germany

    Site Not Available

  • Teva Investigational Site 32873

    Duisburg, 47055
    Germany

    Site Not Available

  • Teva Investigational Site 32793

    Kiel, 24105
    Germany

    Site Not Available

  • Teva Investigational Site 32797

    Leipzig, 04103
    Germany

    Site Not Available

  • Teva Investigational Site 32795

    Tuebingen, 72076
    Germany

    Site Not Available

  • Teva Investigational Site 32794

    Ulm, 89081
    Germany

    Site Not Available

  • Teva Investigational Site 32874

    Wipperfuerth, 51688
    Germany

    Site Not Available

  • Teva Investigational Site 51334

    Budapest, 1085
    Hungary

    Site Not Available

  • Teva Investigational Site 51335

    Budapest, H-1033
    Hungary

    Site Not Available

  • Teva Investigational Site 51336

    Gyongyos, 3200
    Hungary

    Site Not Available

  • Teva Investigational Site 51333

    Szekesfehervar, H-8000
    Hungary

    Site Not Available

  • Teva Investigational Site 51338

    Vac, H-2600
    Hungary

    Site Not Available

  • Teva Investigational Site 80179

    Afula, 1834111
    Israel

    Site Not Available

  • Teva Investigational Site 80191

    Beer Sheva, 8410101
    Israel

    Site Not Available

  • Teva Investigational Site 80191

    Beer-Sheva, 8410101
    Israel

    Site Not Available

  • Teva Investigational Site 80184

    Holon, 58100
    Israel

    Site Not Available

  • Teva Investigational Site 80182

    Kfar Saba, 4428164
    Israel

    Site Not Available

  • Teva Investigational Site 80182

    Kfar-Sava, 4428164
    Israel

    Site Not Available

  • Teva Investigational Site 80180

    Rechovot, 761001
    Israel

    Site Not Available

  • Teva Investigational Site 80180

    Rehovot, 7661041
    Israel

    Site Not Available

  • Teva Investigational Site 30304

    Brescia, 25123
    Italy

    Site Not Available

  • Teva Investigational Site 30285

    Milan, 20132
    Italy

    Site Not Available

  • Teva Investigational Site 30286

    Milan, 20157
    Italy

    Site Not Available

  • Teva Investigational Site 30284

    Rozzano, 20089
    Italy

    Site Not Available

  • Teva Investigational Site 30303

    San Donato Milanese, 20097
    Italy

    Site Not Available

  • Teva Investigational Site 30300

    San Giovanni Rotondo, 71013
    Italy

    Site Not Available

  • Teva Investigational Site 30301

    Turin, 10128
    Italy

    Site Not Available

  • Teva Investigational Site 84114

    Chiba, 285-8741
    Japan

    Site Not Available

  • Teva Investigational Site 84112

    Fukuoka, 814-0180
    Japan

    Site Not Available

  • Teva Investigational Site 84112

    Fukuoka-shi, 814-0180
    Japan

    Site Not Available

  • Teva Investigational Site 84110

    Kashiwa-shi, 277-0871
    Japan

    Site Not Available

  • Teva Investigational Site 84117

    Minato-ku, 108-8642
    Japan

    Site Not Available

  • Teva Investigational Site 84115

    Mitaka-shi, 181-8611
    Japan

    Site Not Available

  • Teva Investigational Site 84118

    Nagoya, 457-8511
    Japan

    Site Not Available

  • Teva Investigational Site 84118

    Nagoya-shi, 457-8511
    Japan

    Site Not Available

  • Teva Investigational Site 84113

    Osaka, 530-0011
    Japan

    Site Not Available

  • Teva Investigational Site 84113

    Osaka-shi, 530-0011
    Japan

    Site Not Available

  • Teva Investigational Site 84114

    Sakura-shi, 285-8741
    Japan

    Site Not Available

  • Teva Investigational Site 84116

    Shinjuku-ku, 169-0073
    Japan

    Site Not Available

  • Teva Investigational Site 84115

    Tokyo, 181-8611
    Japan

    Site Not Available

  • Teva Investigational Site 84116

    Tokyo, 169-0073
    Japan

    Site Not Available

  • Teva Investigational Site 84117

    Tokyo, 108-8642
    Japan

    Site Not Available

  • Teva Investigational Site 84111

    Toyama, 930-8550
    Japan

    Site Not Available

  • Teva Investigational Site 84111

    Toyama-shi, 930-8550
    Japan

    Site Not Available

  • Teva Investigational Site 70012

    Chisinau, 2005
    Moldova, Republic of

    Site Not Available

  • Teva Investigational Site 70013

    Chisinau, MD-2025
    Moldova, Republic of

    Site Not Available

  • Teva Investigational Site 70014

    Chisinau, MD-2025
    Moldova, Republic of

    Site Not Available

  • Teva Investigational Site 41015

    L?renskog, 1478
    Norway

    Site Not Available

  • Teva Investigational Site 41015

    Lorenskog, 1478
    Norway

    Site Not Available

  • Teva Investigational Site 41014

    Tromso, 9038
    Norway

    Site Not Available

  • Teva Investigational Site 53565

    Bydgoszcz, 85-794
    Poland

    Site Not Available

  • Teva Investigational Site 53542

    Czestochowa, 42-202
    Poland

    Site Not Available

  • Teva Investigational Site 53543

    Elblag, 82-300
    Poland

    Site Not Available

  • Teva Investigational Site 53544

    Gdansk, 80-382
    Poland

    Site Not Available

  • Teva Investigational Site 53545

    Gdynia, 81-537
    Poland

    Site Not Available

  • Teva Investigational Site 53571

    Jelenia Gora, 58-500
    Poland

    Site Not Available

  • Teva Investigational Site 53546

    Katowice, 40-040
    Poland

    Site Not Available

  • Teva Investigational Site 53547

    Klodzko, 57-300
    Poland

    Site Not Available

  • Teva Investigational Site 53512

    Krakow, 31-506
    Poland

    Site Not Available

  • Teva Investigational Site 53548

    Krakow, 31-156
    Poland

    Site Not Available

  • Teva Investigational Site 53560

    Krakow, 30-363
    Poland

    Site Not Available

  • Teva Investigational Site 53511

    Leczna, 21-010
    Poland

    Site Not Available

  • Teva Investigational Site 53514

    Lodz, 91-495
    Poland

    Site Not Available

  • Teva Investigational Site 53515

    Lodz, 90-752
    Poland

    Site Not Available

  • Teva Investigational Site 53518

    Nowy Targ, 34-400
    Poland

    Site Not Available

  • Teva Investigational Site 53559

    Opole, 45-819
    Poland

    Site Not Available

  • Teva Investigational Site 53572

    Piotrkow Trybunalski, 97-300
    Poland

    Site Not Available

  • Teva Investigational Site 53516

    Poznan, 60-529
    Poland

    Site Not Available

  • Teva Investigational Site 53517

    Poznan, 60-324
    Poland

    Site Not Available

  • Teva Investigational Site 53566

    Poznan, 60-702
    Poland

    Site Not Available

  • Teva Investigational Site 53513

    Rzeszow, 35-055
    Poland

    Site Not Available

  • Teva Investigational Site 53550

    Sopot, 81-756
    Poland

    Site Not Available

  • Teva Investigational Site 53551

    Staszow, 28-200
    Poland

    Site Not Available

  • Teva Investigational Site 53508

    Szczecin, 71-434
    Poland

    Site Not Available

  • Teva Investigational Site 53519

    Szczecin, 71-685
    Poland

    Site Not Available

  • Teva Investigational Site 53552

    Tarnow, 33-100
    Poland

    Site Not Available

  • Teva Investigational Site 53573

    Tarnow, 33-100
    Poland

    Site Not Available

  • Teva Investigational Site 53553

    Torun, 87-100
    Poland

    Site Not Available

  • Teva Investigational Site 53554

    Wadowice, 34-100
    Poland

    Site Not Available

  • Teva Investigational Site 53555

    Warsaw, 04-501
    Poland

    Site Not Available

  • Teva Investigational Site 53556

    Warsaw, 02-786
    Poland

    Site Not Available

  • Teva Investigational Site 53557

    Warsaw, 00-189
    Poland

    Site Not Available

  • Teva Investigational Site 53570

    Warsaw, 02-672
    Poland

    Site Not Available

  • Teva Investigational Site 53555

    Warszawa, 00-728
    Poland

    Site Not Available

  • Teva Investigational Site 53510

    Wroclaw, 52-416
    Poland

    Site Not Available

  • Teva Investigational Site 53520

    Wroclaw, 53-673
    Poland

    Site Not Available

  • Teva Investigational Site 53549

    Wroclaw, 54-144
    Poland

    Site Not Available

  • Teva Investigational Site 53558

    Wroclaw, 50-381
    Poland

    Site Not Available

  • Teva Investigational Site 53562

    Wroclaw, 53-611
    Poland

    Site Not Available

  • Teva Investigational Site 53563

    Wroclaw, 54-144
    Poland

    Site Not Available

  • Teva Investigational Site 53567

    Wroclaw, 53-149
    Poland

    Site Not Available

  • Teva Investigational Site 53509

    Zamosc, 22-400
    Poland

    Site Not Available

  • Teva Investigational Site 61055

    Belgrade, 11000
    Serbia

    Site Not Available

  • Teva Investigational Site 62097

    Presov, 8001
    Serbia

    Site Not Available

  • Teva Investigational Site 62098

    Banska Bystrica, 975 17
    Slovakia

    Site Not Available

  • Teva Investigational Site 62074

    Bardejov, 085 01
    Slovakia

    Site Not Available

  • Teva Investigational Site 62073

    Bratislava, 811 09
    Slovakia

    Site Not Available

  • Teva Investigational Site 62071

    Kosice, 040 13
    Slovakia

    Site Not Available

  • Teva Investigational Site 62076

    Presov, 080 01
    Slovakia

    Site Not Available

  • Teva Investigational Site 62097

    Presov, 080 01
    Slovakia

    Site Not Available

  • Teva Investigational Site 62099

    Rimavska Sobota, 979 01
    Slovakia

    Site Not Available

  • Teva Investigational Site 62072

    Sahy, 936 01
    Slovakia

    Site Not Available

  • Teva Investigational Site 31325

    Alicante, 03010
    Spain

    Site Not Available

  • Teva Investigational Site 31302

    Cordoba, 14004
    Spain

    Site Not Available

  • Teva Investigational Site 31293

    Huelva, 21005
    Spain

    Site Not Available

  • Teva Investigational Site 31301

    Las Palmas de Gran Canaria, 35010
    Spain

    Site Not Available

  • Teva Investigational Site 31318

    Santiago de Compostela, 15702
    Spain

    Site Not Available

  • Teva Investigational Site 31291

    Sevilla, 41017
    Spain

    Site Not Available

  • Teva Investigational Site 31291

    Seville, 41009
    Spain

    Site Not Available

  • Teva Investigational Site 31292

    Valencia, 46026
    Spain

    Site Not Available

  • Teva Investigational Site 58327

    Chernivtsi, 58002
    Ukraine

    Site Not Available

  • Teva Investigational Site 58324

    Ivano-Frankivsk, 76008
    Ukraine

    Site Not Available

  • Teva Investigational Site 58325

    Lviv, 79010
    Ukraine

    Site Not Available

  • Teva Investigational Site 58329

    Lviv, 79000
    Ukraine

    Site Not Available

  • Teva Investigational Site 58332

    Lviv, 79010
    Ukraine

    Site Not Available

  • Teva Investigational Site 58328

    Ternopil, 46002
    Ukraine

    Site Not Available

  • Teva Investigational Site 58322

    Uzhgorod, 88018
    Ukraine

    Active - Recruiting

  • Teva Investigational Site 58323

    Uzhgorod, 88009
    Ukraine

    Site Not Available

  • Teva Investigational Site 58322

    Uzhhorod, 88000
    Ukraine

    Site Not Available

  • Teva Investigational Site 58323

    Uzhhorod, 88000
    Ukraine

    Site Not Available

  • Teva Investigational Site 58330

    Vinnytsia, 21018
    Ukraine

    Site Not Available

  • Teva Investigational Site 58331

    Vinnytsia, 21018
    Ukraine

    Site Not Available

  • Teva Investigational Site 34305

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Teva Investigational Site 15564

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Teva Investigational Site 15564

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Teva Investigational Site 15568

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Teva Investigational Site 15556

    San Diego, California 92103
    United States

    Site Not Available

  • Teva Investigational Site 15747

    San Diego, California 92103
    United States

    Site Not Available

  • Teva Investigational Site 15357

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Teva Investigational Site 15365

    Miami, Florida 33136
    United States

    Site Not Available

  • Teva Investigational Site 15563

    Miami, Florida 33032
    United States

    Site Not Available

  • Teva Investigational Site 15748

    Miami, Florida 33176
    United States

    Site Not Available

  • Teva Investigational Site 15375

    Orlando, Florida 32803
    United States

    Site Not Available

  • Teva Investigational Site 15359

    Pinellas Park, Florida 33781
    United States

    Site Not Available

  • Teva Investigational Site 15359

    Tampa, Florida 33626
    United States

    Site Not Available

  • Teva Investigational Site 15566

    Glenview, Illinois 60026
    United States

    Site Not Available

  • Teva Investigational Site 15567

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Teva Investigational Site 15574

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Teva Investigational Site 15575

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • Teva Investigational Site 15362

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Teva Investigational Site 15367

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Teva Investigational Site 15358

    Leawood, Kansas 66214
    United States

    Site Not Available

  • Teva Investigational Site 15368

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Teva Investigational Site 15575

    Louisville, Kentucky 40218
    United States

    Site Not Available

  • Teva Investigational Site 15363

    Columbia, Maryland 21045
    United States

    Site Not Available

  • Teva Investigational Site 15744

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Teva Investigational Site 15358

    Liberty, Missouri 64068
    United States

    Site Not Available

  • Teva Investigational Site 15373

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Teva Investigational Site 15369

    Las Vegas, Nevada 89128.
    United States

    Site Not Available

  • Teva Investigational Site 15558

    North Massapequa, New York 11758
    United States

    Site Not Available

  • Teva Investigational Site 15370

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Teva Investigational Site 15750

    Beavercreek, Ohio 45440
    United States

    Site Not Available

  • Teva Investigational Site 15750

    Dayton, Ohio 45415
    United States

    Site Not Available

  • Teva Investigational Site 15557

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Teva Investigational Site 15573

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Teva Investigational Site 15360

    Austin, Texas 78748
    United States

    Site Not Available

  • Teva Investigational Site 15371

    Dallas, Texas 75246
    United States

    Site Not Available

  • Teva Investigational Site 15751

    Dallas, Texas 75246
    United States

    Site Not Available

  • Teva Investigational Site 15569

    Garland, Texas 75044
    United States

    Site Not Available

  • Teva Investigational Site 15559

    Harlingen, Texas 78550
    United States

    Site Not Available

  • Teva Investigational Site 15366

    Katy, Texas 77494
    United States

    Site Not Available

  • Teva Investigational Site 15743

    Lubbock, Texas 79424
    United States

    Site Not Available

  • Teva Investigational Site 15372

    Pearland, Texas 77584
    United States

    Site Not Available

  • Teva Investigational Site 15374

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Teva Investigational Site 15565

    Southlake, Texas 76092
    United States

    Site Not Available

  • Teva Investigational Site 15567

    Southlake, Texas 76092
    United States

    Active - Recruiting

  • Teva Investigational Site 15568

    Southlake, Texas 76092
    United States

    Site Not Available

  • Teva Investigational Site 15361

    Tyler, Texas 75701
    United States

    Site Not Available

  • Teva Investigational Site 15364

    Salt Lake City, Utah 84124
    United States

    Site Not Available

  • Teva Investigational Site 15560

    Vancouver, Washington 98664
    United States

    Site Not Available

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