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

NCT ID: NCT05499130

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2024-11-12

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 of 2 different doses of TEV-48574 as assessed by multiple standard measures
• To evaluate the safety and tolerability of 2 different doses of TEV-48574
• To evaluate the immunogenicity of 2 different dioses of TEV-48574

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.

Conditions

Crohn Disease; Colitis, Ulcerative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TEV-48574, 450 mg (UC)

Administered by subcutaneous infusion for participants with UC

Group Type: EXPERIMENTAL

TEV-48574

Intervention Type: DRUG

Subcutaneous infusion

TEV-48574, 900 mg (UC)

Administered by subcutaneous infusion for participants with UC

Group Type: EXPERIMENTAL

TEV-48574

Intervention Type: DRUG

Subcutaneous infusion

TEV-48574, 1800 mg (UC)

Administered by subcutaneous infusion for participants with UC. This arm was discontinued with Amend 03.

Group Type: EXPERIMENTAL

TEV-48574

Intervention Type: DRUG

Subcutaneous infusion

TEV-48574, 450 mg (CD)

Administered by subcutaneous infusion for participants with CD

Group Type: EXPERIMENTAL

TEV-48574

Intervention Type: DRUG

Subcutaneous infusion

TEV-48574, 900 mg (CD)

Administered by subcutaneous infusion for participants with CD

Group Type: EXPERIMENTAL

TEV-48574

Intervention Type: DRUG

Subcutaneous infusion

TEV-48574, 1800 mg (CD)

Administered by subcutaneous infusion for participants with CD. This arm was discontinued with Amend 03.

Group Type: EXPERIMENTAL

TEV-48574

Intervention Type: DRUG

Subcutaneous infusion

Placebo UC

Matching Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo

Placebo CD

Matching Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo

Interventions

TEV-48574

Subcutaneous infusion

Intervention Type: DRUG

Placebo

Matching Placebo

Intervention Type: DRUG

Other Intervention Names

duvakitug

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 15568

Sun City, Arizona, United States

Teva Investigational Site 15556

San Diego, California, United States

Teva Investigational Site 15747

San Diego, California, United States

Teva Investigational Site 15357

Kissimmee, Florida, United States

Teva Investigational Site 15563

Miami, Florida, United States

Teva Investigational Site 15365

Miami, Florida, United States

Teva Investigational Site 15748

Miami, Florida, United States

Teva Investigational Site 15375

Orlando, Florida, United States

Teva Investigational Site 15359

Pinellas Park, Florida, United States

Teva Investigational Site 15566

Glenview, Illinois, United States

Teva Investigational Site 15567

Gurnee, Illinois, United States

Teva Investigational Site 15574

New Albany, Indiana, United States

Teva Investigational Site 15362

Iowa City, Iowa, United States

Teva Investigational Site 15367

Kansas City, Kansas, United States

Teva Investigational Site 15368

Louisville, Kentucky, United States

Teva Investigational Site 15575

Louisville, Kentucky, United States

Teva Investigational Site 15363

Columbia, Maryland, United States

Teva Investigational Site 15358

Liberty, Missouri, United States

Teva Investigational Site 15373

St Louis, Missouri, United States

Teva Investigational Site 15369

Las Vegas, Nevada, United States

Teva Investigational Site 15558

North Massapequa, New York, United States

Teva Investigational Site 15370

Chapel Hill, North Carolina, United States

Teva Investigational Site 15750

Beavercreek, Ohio, United States

Teva Investigational Site 15557

Greenville, South Carolina, United States

Teva Investigational Site 15573

Cordova, Tennessee, United States

Teva Investigational Site 15360

Austin, Texas, United States

Teva Investigational Site 15371

Dallas, Texas, United States

Teva Investigational Site 15569

Garland, Texas, United States

Teva Investigational Site 15559

Harlingen, Texas, United States

Teva Investigational Site 15366

Katy, Texas, United States

Teva Investigational Site 15743

Lubbock, Texas, United States

Teva Investigational Site 15372

Pearland, 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 33055

Innsbruck, , Austria

Teva Investigational Site 33056

Vienna, , Austria

Teva Investigational Site 37134

Edegem, , Belgium

Teva Investigational Site 37133

Liège, , Belgium

Teva Investigational Site 59243

Gorna Oryahovitsa, , Bulgaria

Teva Investigational Site 59198

Pleven, , Bulgaria

Teva Investigational Site 59197

Sofia, , Bulgaria

Teva Investigational Site 59199

Sofia, , Bulgaria

Teva Investigational Site 59196

Sofia, , Bulgaria

Teva Investigational Site 11257

Winnipeg, Manitoba, Canada

Teva Investigational Site 54221

Brno, , Czechia

Teva Investigational Site 54222

Klatovy, , Czechia

Teva Investigational Site 54241

Prague, , Czechia

Teva Investigational Site 54220

Slaný, , Czechia

Teva Investigational Site 54242

Zábřeh, , Czechia

Teva Investigational Site 35280

Caen, , France

Teva Investigational Site 35295

Nantes, , France

Teva Investigational Site 35277

Nice, , France

Teva Investigational Site 35279

Saint-Priest-en-Jarez, , France

Teva Investigational Site 81057

Tbilisi, , Georgia

Teva Investigational Site 81052

Tbilisi, , Georgia

Teva Investigational Site 81054

Tbilisi, , Georgia

Teva Investigational Site 81056

Tbilisi, , Georgia

Teva Investigational Site 81053

Tbilisi, , Georgia

Teva Investigational Site 81055

Tbilisi, , Georgia

Teva Investigational Site 32796

Berlin, , Germany

Teva Investigational Site 32872

Berlin, , Germany

Teva Investigational Site 32873

Duisburg, , Germany

Teva Investigational Site 32793

Kiel, , Germany

Teva Investigational Site 32797

Leipzig, , Germany

Teva Investigational Site 32795

Tübingen, , Germany

Teva Investigational Site 32794

Ulm, , Germany

Teva Investigational Site 32874

Wipperfürth, , Germany

Teva Investigational Site 51334

Budapest, , Hungary

Teva Investigational Site 51335

Budapest, , Hungary

Teva Investigational Site 51336

Gyöngyös, , Hungary

Teva Investigational Site 51333

Székesfehérvár, , Hungary

Teva Investigational Site 51338

Vác, , Hungary

Teva Investigational Site 80179

Afula, , Israel

Teva Investigational Site 80191

Beersheba, , Israel

Teva Investigational Site 80184

Holon, , Israel

Teva Investigational Site 80182

Kfar Saba, , Israel

Teva Investigational Site 80180

Rehovot, , Israel

Teva Investigational Site 30304

Brescia, , Italy

Teva Investigational Site 30285

Milan, , Italy

Teva Investigational Site 30286

Milan, , Italy

Teva Investigational Site 30284

Rozzano, , Italy

Teva Investigational Site 30303

San Donato Milanese, , Italy

Teva Investigational Site 30300

San Giovanni Rotondo, , Italy

Teva Investigational Site 30301

Turin, , Italy

Teva Investigational Site 84112

Fukuoka, , Japan

Teva Investigational Site 84110

Kashiwa, , Japan

Teva Investigational Site 84118

Nagoya, , Japan

Teva Investigational Site 84113

Osaka, , Japan

Teva Investigational Site 84114

Sakura, , Japan

Teva Investigational Site 84117

Tokyo, , Japan

Teva Investigational Site 84116

Tokyo, , Japan

Teva Investigational Site 84115

Tokyo, , Japan

Teva Investigational Site 84111

Toyama, , Japan

Teva Investigational Site 41015

Lorenskog, , Norway

Teva Investigational Site 41014

Tromsø, , Norway

Teva Investigational Site 53565

Bydgoszcz, , Poland

Teva Investigational Site 53542

Częstochowa, , Poland

Teva Investigational Site 53543

Elblag, , Poland

Teva Investigational Site 53544

Gdansk, , Poland

Teva Investigational Site 53545

Gdynia, , Poland

Teva Investigational Site 53571

Jelenia Góra, , Poland

Teva Investigational Site 53546

Katowice, , Poland

Teva Investigational Site 53560

Krakow, , Poland

Teva Investigational Site 53548

Krakow, , Poland

Teva Investigational Site 53512

Krakow, , Poland

Teva Investigational Site 53547

Kłodzko, , Poland

Teva Investigational Site 53515

Lodz, , Poland

Teva Investigational Site 53514

Lodz, , Poland

Teva Investigational Site 53518

Nowy Targ, , Poland

Teva Investigational Site 53559

Opole, , Poland

Teva Investigational Site 53572

Piotrkow Trybunalski, , Poland

Teva Investigational Site 53517

Poznan, , Poland

Teva Investigational Site 53516

Poznan, , Poland

Teva Investigational Site 53566

Poznan, , Poland

Teva Investigational Site 53513

Rzeszów, , Poland

Teva Investigational Site 53550

Sopot, , Poland

Teva Investigational Site 53551

Staszów, , Poland

Teva Investigational Site 53508

Szczecin, , Poland

Teva Investigational Site 53519

Szczecin, , Poland

Teva Investigational Site 53552

Tarnów, , Poland

Teva Investigational Site 53573

Tarnów, , 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 53558

Wroclaw, , Poland

Teva Investigational Site 53510

Wroclaw, , Poland

Teva Investigational Site 53567

Wroclaw, , Poland

Teva Investigational Site 53562

Wroclaw, , Poland

Teva Investigational Site 53520

Wroclaw, , Poland

Teva Investigational Site 53549

Wroclaw, , Poland

Teva Investigational Site 53563

Wroclaw, , Poland

Teva Investigational Site 53509

Zamość, , Poland

Teva Investigational Site 53511

Łęczna, , Poland

Teva Investigational Site 62098

Banská Bystrica, , Slovakia

Teva Investigational Site 62074

Bardejov, , Slovakia

Teva Investigational Site 62073

Bratislava, , Slovakia

Teva Investigational Site 62071

Košice, , Slovakia

Teva Investigational Site 62076

Prešov, , Slovakia

Teva Investigational Site 62097

Prešov, , Slovakia

Teva Investigational Site 62099

Rimavská Sobota, , Slovakia

Teva Investigational Site 62072

Šahy, , Slovakia

Teva Investigational Site 31325

Alicante, , Spain

Teva Investigational Site 31302

Córdoba, , Spain

Teva Investigational Site 31293

Huelva, , Spain

Teva Investigational Site 31301

Las Palmas de Gran Canaria, , Spain

Teva Investigational Site 31318

Santiago de Compostela, , Spain

Teva Investigational Site 31291

Seville, , 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 58328

Ternopil, , Ukraine

Teva Investigational Site 58322

Uzhhorod, , Ukraine

Teva Investigational Site 58323

Uzhhorod, , Ukraine

Teva Investigational Site 58330

Vinnytsia, , Ukraine

Teva Investigational Site 58331

Vinnytsia, , Ukraine

Teva Investigational Site 34305

London, , United Kingdom

Countries

United States; Austria; Belgium; Bulgaria; Canada; Czechia; France; Georgia; Germany; Hungary; Israel; Italy; Japan; Norway; Poland; Slovakia; Spain; Ukraine; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-006881-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2024-511089-36-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

TV48574-IMM-20036

Identifier Type: -

Identifier Source: org_study_id