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

NCT05668013 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: TV48574-IMM-200382022-002593-892024-515027-11-00
• Study Type: interventional
• Target: 247
• Locations: 16 countries
• Sites: 93

Brief Summary

The primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult participants with inflammatory bowel disease (IBD). Secondary objectives of the study are to:

• evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
• evaluate the safety and tolerability of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
• evaluate the immunogenicity of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD The total duration for a participant in the double-blind period only is 66 weeks; and for a participant in the open-label extension (OLE) period, up to an additional 268 weeks.

Conditions

Crohn Disease; Colitis, Ulcerative

Outcome Measures

Primary Outcomes (2)

• Number of participants with moderate to severe ulcerative colitis (UC) who show clinical remission as defined by the Mayo score

  Clinical remission based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points, which is defined by: * stool frequency subscore of 0 or 1, * rectal bleeding subscore of 0, and * endoscopic subscore of 0 or 1, where a score of 1 does not include "friability"

  Week 44

• Number of participants with moderate to severe Crohn's disease (CD) who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease

  Endoscopic response, defined as a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 50% from DRF study baseline at week 44 in participants with CD

  Week 44

Secondary Outcomes (14)

• Number of participants with moderate to severe UC with a clinical response as defined by Mayo score

  Week 44

• Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score

  Week 44

• Number of participants with moderate to severe UC in Endoscopic remission as defined by Mayo score

  Week 44

• Number of participants with moderate to severe UC with Corticosteroid-free clinical remission based on the modified Mayo score

  Week 44

• Number of participants with moderate to severe CD with a clinical response based on Crohn's Disease Activity Index

  Week 44

Study Arms (4)

TEV-48574 Dose Regimen A for Ulcerative Colitis (UC)

EXPERIMENTAL

Administered by subcutaneous infusion for participants with UC

Drug: TEV-48574 Dose Regimen A

TEV-48574 Dose Regimen A for Crohn's Disease (CD)

EXPERIMENTAL

Administered by subcutaneous infusion for participants with CD

Drug: TEV-48574 Dose Regimen A

TEV-48574 Dose Regimen B for Ulcerative Colitis (UC)

EXPERIMENTAL

Administered by subcutaneous infusion for participants with UC

Drug: TEV-48574 Dose Regiment B

TEV-48574 Dose Regimen B for Crohn's Disease (CD)

EXPERIMENTAL

Administered by subcutaneous infusion for participants with CD

Drug: TEV-48574 Dose Regiment B

Interventions

TEV-48574 Dose Regimen A DRUG

Subcutaneous (sc) administration using a commercial sc infusion system

Also known as: duvakitug

TEV-48574 Dose Regimen A for Crohn's Disease (CD); TEV-48574 Dose Regimen A for Ulcerative Colitis (UC)

TEV-48574 Dose Regiment B DRUG

Subcutaneous (sc) administration using a commercial sc infusion system

Also known as: duvakitug

TEV-48574 Dose Regimen B for Crohn's Disease (CD); TEV-48574 Dose Regimen B for Ulcerative Colitis (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:

• Maintenance Period- Participants who achieved clinical response and/or clinical remission at week 14 of TV48574-IMM-20036 (the 14-week DRF study) or in the re-induction period of this study.
• Re-induction- Participants who did not achieve clinical response and/or clinical remission at week 14 of the TV48574-IMM-20036 DRF study
• NOTE- Additional criteria may apply, please contact the investigator for more information

You may not qualify if:

• Participants who discontinued the TV48574-IMM-20036 study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons)
• 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.
• Participant anticipates requiring major surgery during this study.
• 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.
• NOTE- Additional criteria apply, please contact the investigator for more information

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D LLC: lead
• Sanofi: collaborator

Study Sites (93)

Teva Investigational Site 15556

San Diego, California, 92103, United States

Location

Teva Investigational Site 15357

Kissimmee, Florida, 34741, 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 15567

Gurnee, Illinois, 60031, United States

Location

Teva Investigational Site 15574

New Albany, Indiana, 47150, United States

Location

Teva Investigational Site 15367

Kansas City, Kansas, 66160, United States

Location

Teva Investigational Site 15575

Louisville, Kentucky, 40218, 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 15750

Beavercreek, Ohio, 45440, 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 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 33056

Vienna, 1090, Austria

Location

Teva Investigational Site 59243

Gorna Oryahovitsa, 5100, Bulgaria

Location

Teva Investigational Site 59197

Sofia, 1618, Bulgaria

Location

Teva Investigational Site 59196

Sofia, 1784, Bulgaria

Location

Teva Investigational Site 54221

Brno, 615 00, Czechia

Location

Teva Investigational Site 54222

Klatovy, 339 01, Czechia

Location

Teva Investigational Site 54220

Slaný, 274 01, Czechia

Location

Teva Investigational Site 81052

Tbilisi, 0119, Georgia

Location

Teva Investigational Site 81053

Tbilisi, 0180, Georgia

Location

Teva Investigational Site 32793

Kiel, 24105, 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 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 30285

Milan, 20132, Italy

Location

Teva Investigational Site 30286

Milan, 20157, Italy

Location

Teva Investigational Site 30284

Rozzano, 20089, Italy

Location

Teva Investigational Site 84110

Kashiwa, 277-0871, Japan

Location

Teva Investigational Site 84117

Minato, 108-8642, 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 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 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 53518

Nowy Targ, 34-400, Poland

Location

Teva Investigational Site 53549

Poznan, 54-144, Poland

Location

Teva Investigational Site 53563

Poznan, 54-144, Poland

Location

Teva Investigational Site 53516

Poznan, 60-529, Poland

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Teva Investigational Site 53566

Poznan, 60-702, Poland

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Teva Investigational Site 53550

Sopot, 81-756, Poland

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Teva Investigational Site 53551

Staszów, 28-200, Poland

Location

Teva Investigational Site 53508

Szczecin, 71-434, Poland

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Teva Investigational Site 53519

Szczecin, 71-685, Poland

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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

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Teva Investigational Site 53570

Warsaw, 02-672, Poland

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Teva Investigational Site 53556

Warsaw, 02-786, Poland

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Teva Investigational Site 53555

Warsaw, 04-501, Poland

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Teva Investigational Site 53510

Wroclaw, 52-416, Poland

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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

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Teva Investigational Site 53509

Zamość, 22-400, Poland

Location

Teva Investigational Site 53511

Łęczna, 21-010, Poland

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

Location

Teva Investigational Site 62076

Prešov, 080 01, Slovakia

Location

Teva Investigational Site 62097

Prešov, 080 01, Slovakia

Location

Teva Investigational Site 31293

Huelva, 21005, Spain

Location

Teva Investigational Site 31318

Santiago de Compostela, 15702, Spain

Location

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

Location

Teva Investigational Site 58332

Lviv, 79010, Ukraine

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Teva Investigational Site 58322

Uzhhorod, 88018, 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

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D LLC

  STUDY DIRECTOR

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: December 12, 2022
• First Posted: December 29, 2022
• Study Start: January 11, 2023
• Primary Completion: January 5, 2026
• Study Completion (Estimated): March 8, 2031
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (18); UA (8); IL (2); DE (4); GE (2); NO (1); ES (3); BU (3); CZ (3); JP (5); GB (1); AU (1); PL (31); SL (5); IT (3); HU (3)