TEV-48574 for Inflammatory Bowel Disease

Recruiting at 140 trial locations

Overseen By Teva U.S. Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Teva Branded Pharmaceutical Products R&D LLC

Disqualifiers: Pregnancy, Major surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 66 weeks

218 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of the drug TEV-48574 for individuals with inflammatory bowel disease (IBD), specifically ulcerative colitis (UC) or Crohn's disease (CD). The study examines two different dosing plans to determine which is most effective and safe when administered every four weeks. Participants should have already shown some improvement or require another round of treatment after a previous related study. Those struggling with UC or CD who have not found relief with current treatments may find this trial suitable. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to contact the study investigator for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that TEV-48574, a treatment for inflammatory bowel disease (IBD), holds promise for safety. Studies have found that patients generally tolerate this medication well. TEV-48574 targets a protein called TL1A, which causes inflammation. This method appears effective and safe.

Specifically, research suggests that TEV-48574 is safe for initial treatment in adults with ulcerative colitis and Crohn's disease, two types of IBD. Previous studies with positive outcomes support the medication's safety. Patients mostly experienced mild to moderate side effects, which were manageable.

Overall, studies have shown that TEV-48574 is well-tolerated, and its safety profile is encouraging for those considering joining clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about TEV-48574 for inflammatory bowel disease because it offers a potentially novel approach to treating both ulcerative colitis (UC) and Crohn's disease (CD). Unlike most current treatments like anti-TNF medications or corticosteroids, which broadly suppress the immune system, TEV-48574 is administered via subcutaneous infusion and may target specific pathways involved in inflammation. This targeted approach could lead to fewer side effects while effectively managing symptoms. The ability to tailor treatment through different dosing regimens for UC and CD further distinguishes TEV-48574 from existing therapies.

What evidence suggests that this trial's treatments could be effective for inflammatory bowel disease?

Research has shown that TEV-48574 may help treat inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD). In earlier studies, TEV-48574, which targets a protein called TL1A involved in inflammation, showed positive results. This trial will test different dose regimens of TEV-48574 for both UC and CD. Specifically, for UC, the treatment proved effective and well-tolerated, reducing inflammation and symptoms without significant side effects. For CD, more patients who took TEV-48574 went into remission compared to those on a placebo. The data also indicate that the treatment safely and effectively targets the intended protein. These findings are promising for managing IBD. ^{1 3 5 6 7}

Who Is on the Research Team?

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D LLC

Are You a Good Fit for This Trial?

This trial is for adults with moderate to severe Ulcerative Colitis or Crohn's Disease who showed improvement in a previous 14-week study. Women must not be pregnant, should test negative for pregnancy, and use effective birth control. Men with partners of childbearing potential must use condoms.

Inclusion Criteria

Re-induction- Participants who did not achieve clinical response and/or clinical remission at week 14 of the TV48574-IMM-20036 DRF study

I showed improvement or remission at week 14 of my previous study.

Exclusion Criteria

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

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

I expect to need major surgery during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TEV-48574 subcutaneous infusions every 4 weeks in a double-blind period

66 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may opt into continuation of treatment long-term with TEV-48574

Up to 268 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TEV-48574

Trial Overview The trial tests two different long-term dosing regimens of TEV-48574, administered every four weeks by injection under the skin. It aims to determine the effectiveness, safety, tolerability, and immune response over up to 66 weeks per participant.

How Is the Trial Designed?

Group I: TEV-48574 Dose Regimen B for Ulcerative Colitis (UC) Experimental Treatment 1 Intervention

Administered by subcutaneous infusion for participants with UC

Group II: TEV-48574 Dose Regimen B for Crohn's Disease (CD) Experimental Treatment 1 Intervention

Administered by subcutaneous infusion for participants with CD

Group III: TEV-48574 Dose Regimen A for Ulcerative Colitis (UC) Experimental Treatment 1 Intervention

Administered by subcutaneous infusion for participants with UC

Group IV: TEV-48574 Dose Regimen A for Crohn's Disease (CD) Experimental Treatment 1 Intervention

Administered by subcutaneous infusion for participants with CD

Who Is Running the Clinical Trial?

Teva Branded Pharmaceutical Products R&D LLC

Lead Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Lead Sponsor

Trials

258

Recruited

3,487,000+

Dr. Eric Hughes

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Medical Officer since 2022

MD and PhD from Yale School of Medicine

Richard Francis

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Executive Officer since 2022

Bachelor's degree in Biochemistry from the University of Manchester

Sanofi

Industry Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

In a clinical trial involving 36 patients with active ulcerative colitis, the anti-TNF antibody AVX-470 demonstrated significant reductions in inflammatory biomarkers, including over a 10-fold decrease in TNF levels after 4 weeks of treatment at the highest dose (3.5g/day).

The presence of bovine immunoglobulin in colon tissue confirmed the local activity of AVX-470, supporting its mechanism of action in targeting inflammation in the gastrointestinal tract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of AVX-470, an Oral, Locally Acting Anti-Tumour Necrosis Factor Antibody, on Tissue Biomarkers in Patients with Active Ulcerative Colitis. Hartman, DS., Tracey, DE., Lemos, BR., et al.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05668013

A Study to Evaluate the Long-Term Effect of TEV-48574 in ... 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 ...

2. academic.oup.com academic.oup.com/ecco-jcc/article/19/Supplement_1/i79/7966919

OP41 Duvakitug (TEV-48574), an anti-TL1a monoclonal ... Both duvakitug doses successfully achieved the week 14 primary endpoint of clinical remission (36% [450 mg], 48% [900 mg] versus 20% [PBO]; PBO- ...

3. tevausa.com tevausa.com/news-and-media/press-releases/teva-presents-new-data-supporting-safety-tolerability-and-target-engagement-of-anti-tl1a-tev-574-anti/

Teva Presents New Data Supporting Safety, Tolerability ... The data show the rapid and sustained suppression of free TL1A, confirming the target engagement of anti-TL1A (TEV-'574), and show a well-tolerated safety ...

4. ir.tevapharm.com ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Teva-and-Sanofi-Present-New-Positive-Phase-2b-Study-Results-at-ECCO-2025-ReinforcingBest-in-Class-Potential-of-Duvakitug-Anti-TL1A-in-Ulcerative-Colitis-and-Crohns-Disease/default.aspx

Teva and Sanofi Present New Positive Phase 2b Study ... Duvakitug (TEV-48574), an anti-TL1A monoclonal antibody, demonstrates efficacy and favourable safety as an induction treatment in adults with ...

5. clinicaltrial.be clinicaltrial.be/en/details/190675?per_page=100&only_recruiting=0&only_eligible=0

A Study to Evaluate the Long-Term Effect of TEV-48574 in... 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 ...

6. academic.oup.com academic.oup.com/ecco-jcc/article/19/Supplement_1/i77/7966998

OP40 Duvakitug (TEV-48574), an anti-TL1a monoclonal ... These are the first data reported for a double-blind, randomised, PBO-controlled induction study of an anti-TL1A antibody in patients with CD.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666634024001223

TL1A inhibition for inflammatory bowel disease treatment Investigational drug TEV-48574, potentially exerting dual antifibrotic and anti-inflammatory effects, is undergoing a phase 2 basket study in ...