TEV-48574 for Ulcerative Colitis and Crohn's Disease

(RELIEVE UCCD Trial)

No longer recruiting at 231 trial locations

Overseen By Teva U.S. Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Disqualifiers: Infections, Colitis, Obstruction, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called TEV-48574, an experimental drug, for individuals with moderate to severe Ulcerative Colitis or Crohn's Disease. The study aims to determine if this treatment can induce clinical remission in Ulcerative Colitis or improve endoscopic conditions in Crohn's Disease after 14 weeks. The trial will test two different doses of TEV-48574 to assess their safety and efficacy. Individuals who have had Ulcerative Colitis or Crohn's Disease for at least three months and seek new treatment options might be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

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 tested for Ulcerative Colitis and Crohn's Disease, is generally well-tolerated. Previous studies found that TEV-48574 effectively targets TL1A, a protein linked to inflammation, without causing serious side effects. The treatment proved safe at different doses, maintaining a positive safety record.

For both Ulcerative Colitis and Crohn's Disease, the treatment was tested in various groups and consistently proved safe. Participants did not experience significant negative effects, indicating that the treatment is well-tolerated. Additionally, TEV-48574 was tested in healthy individuals and those with asthma, further confirming its safety at different doses.

These findings build confidence in the safety of TEV-48574 for those considering joining the trial for Ulcerative Colitis or Crohn's Disease. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for IBD?

Unlike the standard treatments for ulcerative colitis and Crohn's disease, which often include corticosteroids, immunosuppressants, and biologics like TNF inhibitors, TEV-48574 offers a novel approach. This treatment is administered via subcutaneous infusion, which may offer a more convenient delivery method compared to intravenous options. Researchers are excited about TEV-48574 because it represents a potential new class of therapy with a unique mechanism of action, possibly offering benefits for patients who do not respond well to existing treatments. Additionally, the study investigates different doses to optimize effectiveness for both ulcerative colitis and Crohn's disease, giving hope for more personalized treatment options.

What evidence suggests that TEV-48574 might be an effective treatment for IBD?

Research has shown that TEV-48574 may help treat Ulcerative Colitis (UC) and Crohn's Disease (CD). This trial will evaluate different dosages of TEV-48574 for both conditions. The medication targets a protein called TL1A, which causes inflammation, and helps reduce it in the gut. Studies have found that TEV-48574 can effectively lead to remission in UC patients, significantly decreasing or eliminating symptoms. For CD, early results suggest it controls inflammation more effectively. Positive safety data and reduced inflammation in early studies support its potential for these conditions. Overall, TEV-48574 shows promise in managing these challenging diseases. ^{1 2 3 4 6}

Who Is on the Research Team?

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Are You a Good Fit for This Trial?

Adults with moderate to severe Ulcerative Colitis or Crohn's Disease for at least 3 months can join. They must be able to understand the study and follow its rules. Women not of childbearing potential and men (even if vasectomized) with partners who can bear children must use contraception during the study.

Inclusion Criteria

I understand the study and its risks.

I have been diagnosed with Ulcerative Colitis or Crohn's Disease for at least 3 months.

I can communicate well and follow the study's requirements.

Exclusion Criteria

I have been diagnosed with a specific type of colitis.

I have a serious colon condition that might prevent a safe endoscopy.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

Treatment

Participants receive TEV-48574 or placebo for 14 weeks to assess efficacy, safety, and tolerability

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TEV-48574

Trial Overview The trial is testing TEV-48574, a new treatment for IBD, against a placebo. The main goal is to see if it helps achieve clinical remission in UC or endoscopic response in CD after 14 weeks. Participants will also be checked for safety, tolerability, dose response, and immune reaction.

How Is the Trial Designed?

Group I: TEV-48574, 900 mg (UC) Experimental Treatment 1 Intervention

Administered by subcutaneous infusion for participants with UC

Group II: TEV-48574, 900 mg (CD) Experimental Treatment 1 Intervention

Administered by subcutaneous infusion for participants with CD

Group III: TEV-48574, 450 mg (UC) Experimental Treatment 1 Intervention

Administered by subcutaneous infusion for participants with UC

Group IV: TEV-48574, 450 mg (CD) Experimental Treatment 1 Intervention

Administered by subcutaneous infusion for participants with CD

Group V: TEV-48574, 1800 mg (UC) Experimental Treatment 1 Intervention

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

Group VI: TEV-48574, 1800 mg (CD) Experimental Treatment 1 Intervention

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

Group VII: Placebo UC Placebo Group 1 Intervention

Matching Placebo

Group VIII: Placebo CD Placebo Group 1 Intervention

Matching Placebo

Who Is Running the Clinical Trial?

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

Vedolizumab is a monoclonal antibody that effectively targets the α4β7 integrin to inhibit gut lymphocyte trafficking, providing a safe treatment option for patients with moderate to severe Crohn's disease and ulcerative colitis.

Unlike anti-TNF agents, which some patients may become intolerant to or lose response over time, vedolizumab offers a promising alternative for those who are primary nonresponders or have developed antidrug antibodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vedolizumab as a Treatment for Crohn's Disease and Ulcerative Colitis. Ha, C., Kornbluth, A.[2022]

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/i77/7966998

OP40 Duvakitug (TEV-48574), an anti-TL1a monoclonal ... Duvakitug has demonstrated reduced inflammation and fibrosis in colitis animal models.1 Few data are available for the potential of anti-TL1A ...

3. 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 ...

4. 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 ...

5. 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 ...

6. eposters.ddw.org eposters.ddw.org/ddw/2024/ddw-2024/415768/rajiv.balyan.first-in-human.pharmacokinetic.and.safety.study.of.an.anti-tl1a.html?f=menu%3D6%2Abrowseby%3D8%2Asortby%3D2%2Ace_id%3D2673%2Aot_id%3D28936%2Amarker%3D5006

FIRST-IN-HUMAN PHARMACOKINETIC AND SAFETY ... Conclusions: TEV-48574 was well tolerated at all tested doses in healthy and participants with asthma, with dose proportional increases in ...