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

NCT05499130 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: TV48574-IMM-200362021-006881-192024-511089-36-00
• Study Type: interventional
• Target: 290
• Locations: 19 countries
• Sites: 164

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Moderate to Severe UC Who Showed Clinical Remission as Defined by the MMS

  The MMS is a tool designed to measure disease activity for UC. It consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review. Each subscore was graded from 0 (normal) to 3 (severe). These individual subscores were summed up to give a total MMS ranging from 0 (normal or inactive disease) to 9 (severe disease), where higher scores indicated more severe disease activity. Clinical remission was defined as MMS ≤2 points with Mayo stool frequency subscore of 0 or 1, Mayo rectal bleeding subscore of 0, and centrally read endoscopic score of 0 or 1, where a score of 1 did not include "friability".

  Week 14

• Number of Participants With Moderate to Severe CD Who Showed an Endoscopic Response as Defined by the SES-CD

  The SES-CD assessed the degree of inflammation. The SES-CD assesses the following 4 components: presence of ulcers, percentage of ulcerated surfaces, affected surface, and presence of strictures. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components was assessed in the 5 segments: the rectum, sigmoid and left colon, transverse colon, right colon, and ileum. The SES-CD was the sum of the individual scores of each of the components across the 5 segments. The range of SES-CD scores was 0 (none) - 12 (severe) for each segment, and 0 (none) - 60 (severe) for the overall SES-CD score, with larger scores indicating greater degree of inflammation. Endoscopic response at Week 14 in participants with moderate to severe CD was defined as a reduction in SES-CD of at least 50% from baseline.

  Baseline to Week 14

Secondary Outcomes (14)

• Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by the MMS

  Baseline to Week 14

• Number of Participants With Moderate to Severe UC With Endoscopic Improvement as Defined by the Mayo Endoscopic Subscore (MES)

  Week 14

• Number of Participants With Moderate to Severe UC With Endoscopic Remission as Defined by the MES

  Week 14

• Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by 2-item Patient-reported Outcome (PRO2) Score

  Baseline to Week 14

• Number of Participants With Moderate to Severe UC With a Clinical Remission as Defined by PRO2 Score

  Week 14

Study Arms (8)

TEV-48574, 450 mg (UC)

EXPERIMENTAL

Administered by subcutaneous infusion for participants with UC

Drug: TEV-48574

TEV-48574, 900 mg (UC)

EXPERIMENTAL

Administered by subcutaneous infusion for participants with UC

Drug: TEV-48574

TEV-48574, 1800 mg (UC)

EXPERIMENTAL

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

Drug: TEV-48574

TEV-48574, 450 mg (CD)

EXPERIMENTAL

Administered by subcutaneous infusion for participants with CD

Drug: TEV-48574

TEV-48574, 900 mg (CD)

EXPERIMENTAL

Administered by subcutaneous infusion for participants with CD

Drug: TEV-48574

TEV-48574, 1800 mg (CD)

EXPERIMENTAL

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

Drug: TEV-48574

Placebo UC

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo

Placebo CD

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo

Interventions

TEV-48574 DRUG

Subcutaneous infusion

Also known as: duvakitug

TEV-48574, 1800 mg (CD); TEV-48574, 1800 mg (UC); TEV-48574, 450 mg (CD); TEV-48574, 450 mg (UC); TEV-48574, 900 mg (CD); TEV-48574, 900 mg (UC)

Placebo DRUG

Matching Placebo

Placebo CD; Placebo UC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: collaborator
• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (164)

Teva Investigational Site 15568

Sun City, Arizona, 85351, United States

Location

Teva Investigational Site 15556

San Diego, California, 92103, United States

Location

Teva Investigational Site 15747

San Diego, California, 92103, United States

Location

Teva Investigational Site 15357

Kissimmee, Florida, 34741, United States

Location

Teva Investigational Site 15563

Miami, Florida, 33032, United States

Location

Teva Investigational Site 15365

Miami, Florida, 33136, United States

Location

Teva Investigational Site 15748

Miami, Florida, 33176, United States

Location

Teva Investigational Site 15375

Orlando, Florida, 32803, United States

Location

Teva Investigational Site 15359

Pinellas Park, Florida, 33781, United States

Location

Teva Investigational Site 15566

Glenview, Illinois, 60026, United States

Location

Teva Investigational Site 15567

Gurnee, Illinois, 60031, United States

Location

Teva Investigational Site 15574

New Albany, Indiana, 47150, United States

Location

Teva Investigational Site 15362

Iowa City, Iowa, 52242, United States

Location

Teva Investigational Site 15367

Kansas City, Kansas, 66160, United States

Location

Teva Investigational Site 15368

Louisville, Kentucky, 40202, United States

Location

Teva Investigational Site 15575

Louisville, Kentucky, 40218, United States

Location

Teva Investigational Site 15363

Columbia, Maryland, 21045, United States

Location

Teva Investigational Site 15358

Liberty, Missouri, 64068, United States

Location

Teva Investigational Site 15373

St Louis, Missouri, 63110, United States

Location

Teva Investigational Site 15369

Las Vegas, Nevada, 89128., United States

Location

Teva Investigational Site 15558

North Massapequa, New York, 11758, United States

Location

Teva Investigational Site 15370

Chapel Hill, North Carolina, 27514, United States

Location

Teva Investigational Site 15750

Beavercreek, Ohio, 45440, United States

Location

Teva Investigational Site 15557

Greenville, South Carolina, 29607, United States

Location

Teva Investigational Site 15573

Cordova, Tennessee, 38018, United States

Location

Teva Investigational Site 15360

Austin, Texas, 78748, United States

Location

Teva Investigational Site 15371

Dallas, Texas, 75246, United States

Location

Teva Investigational Site 15569

Garland, Texas, 75044, United States

Location

Teva Investigational Site 15559

Harlingen, Texas, 78550, United States

Location

Teva Investigational Site 15366

Katy, Texas, 77494, United States

Location

Teva Investigational Site 15743

Lubbock, Texas, 79424, United States

Location

Teva Investigational Site 15372

Pearland, Texas, 77584, United States

Location

Teva Investigational Site 15374

San Antonio, Texas, 78229, United States

Location

Teva Investigational Site 15565

Southlake, Texas, 76092, United States

Location

Teva Investigational Site 15361

Tyler, Texas, 75701, United States

Location

Teva Investigational Site 15364

Salt Lake City, Utah, 84124, United States

Location

Teva Investigational Site 33055

Innsbruck, 6020, Austria

Location

Teva Investigational Site 33056

Vienna, 1090, Austria

Location

Teva Investigational Site 37134

Edegem, 2650, Belgium

Location

Teva Investigational Site 37133

Liège, 4000, Belgium

Location

Teva Investigational Site 59243

Gorna Oryahovitsa, 5100, Bulgaria

Location

Teva Investigational Site 59198

Pleven, 5803, Bulgaria

Location

Teva Investigational Site 59197

Sofia, 1618, Bulgaria

Location

Teva Investigational Site 59199

Sofia, 1680, Bulgaria

Location

Teva Investigational Site 59196

Sofia, 1784, Bulgaria

Location

Teva Investigational Site 11257

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Teva Investigational Site 54221

Brno, 615 00, Czechia

Location

Teva Investigational Site 54222

Klatovy, 339 01, Czechia

Location

Teva Investigational Site 54241

Prague, 140 00, Czechia

Location

Teva Investigational Site 54220

Slaný, 274 01, Czechia

Location

Teva Investigational Site 54242

Zábřeh, 78901, Czechia

Location

Teva Investigational Site 35280

Caen, 14000, France

Location

Teva Investigational Site 35295

Nantes, 44300, France

Location

Teva Investigational Site 35277

Nice, 06200, France

Location

Teva Investigational Site 35279

Saint-Priest-en-Jarez, 42270, France

Location

Teva Investigational Site 81057

Tbilisi, 0102, Georgia

Location

Teva Investigational Site 81052

Tbilisi, 0119, Georgia

Location

Teva Investigational Site 81054

Tbilisi, 0160, Georgia

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Teva Investigational Site 81056

Tbilisi, 0178, Georgia

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Teva Investigational Site 81053

Tbilisi, 0180, Georgia

Location

Teva Investigational Site 81055

Tbilisi, 0180, Georgia

Location

Teva Investigational Site 32796

Berlin, 10318, Germany

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Teva Investigational Site 32872

Berlin, 12559, Germany

Location

Teva Investigational Site 32873

Duisburg, 47055, Germany

Location

Teva Investigational Site 32793

Kiel, 24105, Germany

Location

Teva Investigational Site 32797

Leipzig, 04103, Germany

Location

Teva Investigational Site 32795

Tübingen, 72076, Germany

Location

Teva Investigational Site 32794

Ulm, 89081, Germany

Location

Teva Investigational Site 32874

Wipperfürth, 51688, Germany

Location

Teva Investigational Site 51334

Budapest, 1085, Hungary

Location

Teva Investigational Site 51335

Budapest, H-1033, Hungary

Location

Teva Investigational Site 51336

Gyöngyös, 3200, Hungary

Location

Teva Investigational Site 51333

Székesfehérvár, H-8000, Hungary

Location

Teva Investigational Site 51338

Vác, H-2600, Hungary

Location

Teva Investigational Site 80179

Afula, 1834111, Israel

Location

Teva Investigational Site 80191

Beersheba, 8410101, Israel

Location

Teva Investigational Site 80184

Holon, 58100, Israel

Location

Teva Investigational Site 80182

Kfar Saba, 4428164, Israel

Location

Teva Investigational Site 80180

Rehovot, 7661041, Israel

Location

Teva Investigational Site 30304

Brescia, 25123, Italy

Location

Teva Investigational Site 30285

Milan, 20132, Italy

Location

Teva Investigational Site 30286

Milan, 20157, Italy

Location

Teva Investigational Site 30284

Rozzano, 20089, Italy

Location

Teva Investigational Site 30303

San Donato Milanese, 20097, Italy

Location

Teva Investigational Site 30300

San Giovanni Rotondo, 71013, Italy

Location

Teva Investigational Site 30301

Turin, 10128, Italy

Location

Teva Investigational Site 84112

Fukuoka, 814-0180, Japan

Location

Teva Investigational Site 84110

Kashiwa, 277-0871, Japan

Location

Teva Investigational Site 84117

Minato, 108-8642, Japan

Location

Teva Investigational Site 84115

Mitaka, 181-8611, Japan

Location

Teva Investigational Site 84118

Nagoya, 457-8511, Japan

Location

Teva Investigational Site 84113

Osaka, 530-0011, Japan

Location

Teva Investigational Site 84114

Sakura, 285-8741, Japan

Location

Teva Investigational Site 84116

Shinjuku, 169-0073, Japan

Location

Teva Investigational Site 84111

Toyama, 930-8550, Japan

Location

Teva Investigational Site 41015

Lorenskog, 1478, Norway

Location

Teva Investigational Site 41014

Tromsø, 9038, Norway

Location

Teva Investigational Site 53565

Bydgoszcz, 85-794, Poland

Location

Teva Investigational Site 53542

Częstochowa, 42-202, Poland

Location

Teva Investigational Site 53543

Elblag, 82-300, Poland

Location

Teva Investigational Site 53544

Gdansk, 80-382, Poland

Location

Teva Investigational Site 53545

Gdynia, 81-537, Poland

Location

Teva Investigational Site 53571

Jelenia Góra, 58-500, Poland

Location

Teva Investigational Site 53546

Katowice, 40-040, Poland

Location

Teva Investigational Site 53560

Krakow, 30-363, Poland

Location

Teva Investigational Site 53548

Krakow, 31-156, Poland

Location

Teva Investigational Site 53512

Krakow, 31-506, Poland

Location

Teva Investigational Site 53547

Kłodzko, 57-300, Poland

Location

Teva Investigational Site 53515

Lodz, 90-752, Poland

Location

Teva Investigational Site 53514

Lodz, 91-495, Poland

Location

Teva Investigational Site 53518

Nowy Targ, 34-400, Poland

Location

Teva Investigational Site 53559

Opole, 45-819, Poland

Location

Teva Investigational Site 53572

Piotrkow Trybunalski, 97-300, Poland

Location

Teva Investigational Site 53549

Poznan, 54-144, Poland

Location

Teva Investigational Site 53563

Poznan, 54-144, Poland

Location

Teva Investigational Site 53517

Poznan, 60-324, Poland

Location

Teva Investigational Site 53516

Poznan, 60-529, Poland

Location

Teva Investigational Site 53566

Poznan, 60-702, Poland

Location

Teva Investigational Site 53513

Rzeszów, 35-326, Poland

Location

Teva Investigational Site 53550

Sopot, 81-756, Poland

Location

Teva Investigational Site 53551

Staszów, 28-200, Poland

Location

Teva Investigational Site 53508

Szczecin, 71-434, Poland

Location

Teva Investigational Site 53519

Szczecin, 71-685, Poland

Location

Teva Investigational Site 53552

Tarnów, 33-100, Poland

Location

Teva Investigational Site 53573

Tarnów, 33-100, Poland

Location

Teva Investigational Site 53553

Torun, 87-100, Poland

Location

Teva Investigational Site 53554

Wadowice, 34-100, Poland

Location

Teva Investigational Site 53557

Warsaw, 00-189, Poland

Location

Teva Investigational Site 53570

Warsaw, 02-672, Poland

Location

Teva Investigational Site 53556

Warsaw, 02-786, Poland

Location

Teva Investigational Site 53555

Warsaw, 04-501, Poland

Location

Teva Investigational Site 53558

Wroclaw, 50-381, Poland

Location

Teva Investigational Site 53510

Wroclaw, 52-416, Poland

Location

Teva Investigational Site 53567

Wroclaw, 53-149, Poland

Location

Teva Investigational Site 53562

Wroclaw, 53-611, Poland

Location

Teva Investigational Site 53520

Wroclaw, 53-673, Poland

Location

Teva Investigational Site 53509

Zamość, 22-400, Poland

Location

Teva Investigational Site 53511

Łęczna, 21-010, Poland

Location

Teva Investigational Site 62098

Banská Bystrica, 975 17, Slovakia

Location

Teva Investigational Site 62074

Bardejov, 085 01, Slovakia

Location

Teva Investigational Site 62073

Bratislava, 811 09, Slovakia

Location

Teva Investigational Site 62071

Košice, 040 13, Slovakia

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Teva Investigational Site 62076

Prešov, 080 01, Slovakia

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Teva Investigational Site 62097

Prešov, 080 01, Slovakia

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Teva Investigational Site 62099

Rimavská Sobota, 979 01, Slovakia

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Teva Investigational Site 62072

Šahy, 936 01, Slovakia

Location

Teva Investigational Site 31325

Alicante, 03010, Spain

Location

Teva Investigational Site 31302

Córdoba, 14004, Spain

Location

Teva Investigational Site 31293

Huelva, 21005, Spain

Location

Teva Investigational Site 31301

Las Palmas de Gran Canaria, 35010, Spain

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Teva Investigational Site 31318

Santiago de Compostela, 15702, Spain

Location

Teva Investigational Site 31291

Seville, 41009, Spain

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Teva Investigational Site 31292

Valencia, 46026, Spain

Location

Teva Investigational Site 58327

Chernivtsi, 58002, Ukraine

Location

Teva Investigational Site 58324

Ivano-Frankivsk, 76008, Ukraine

Location

Teva Investigational Site 58329

Lviv, 79000, Ukraine

Location

Teva Investigational Site 58325

Lviv, 79010, Ukraine

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Teva Investigational Site 58332

Lviv, 79010, Ukraine

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Teva Investigational Site 58328

Ternopil, 46002, Ukraine

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Teva Investigational Site 58322

Uzhhorod, 88000, Ukraine

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Teva Investigational Site 58323

Uzhhorod, 88000, Ukraine

Location

Teva Investigational Site 58330

Vinnytsia, 21018, Ukraine

Location

Teva Investigational Site 58331

Vinnytsia, 21018, Ukraine

Location

Teva Investigational Site 34305

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Limitations and Caveats

The treatment arm TEV-48574 1800 mg was discontinued. Therefore, the participants randomized to TEV-48574 1800 mg arm were not included in the overall efficacy analysis for the trial (mITT Analysis Set).

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

USMedInfo@tevapharm.com

888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 12, 2022
• Study Start: September 30, 2022
• Primary Completion: November 12, 2024
• Study Completion: November 12, 2024
• Last Updated: March 27, 2026
• Results First Posted: December 5, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

IL (5); NO (2); US (36); BE (2); ES (7); IT (7); JP (9); FR (4); CA (1); DE (8); PL (41); CZ (5); SL (8); GB (1); UA (10); BU (5); GE (6); AU (2); HU (5)