TEV-48574 for Ulcerative Colitis and Crohn's Disease

(RELIEVE UCCD Trial)

Recruiting at 202 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

290 Participants Needed

Trial Summary

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.

How is the drug TEV-48574 different from other treatments for ulcerative colitis and Crohn's disease?

TEV-48574 is unique because it is an oral treatment that combines two domain antibodies targeting TNFα and IL-23, potentially offering improved safety and efficacy compared to traditional monoclonal antibody therapies, which are usually administered via injection. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new medication called TEV-48574 on adults with moderate to severe Ulcerative Colitis or Crohn's Disease. The goal is to see if it can reduce inflammation and improve their symptoms.

Research Team

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: TEV-48574 Dose B (UC) Experimental Treatment 1 Intervention

Dose regimen B administered by Subcutaneous infusion for participants with UC

Group II: TEV-48574 Dose B (CD) Experimental Treatment 1 Intervention

Dose regimen B administered by subcutaneous infusion for participants with CD

Group III: TEV-48574 Dose A (UC) Experimental Treatment 1 Intervention

Dose regimen A administered by subcutaneous infusion for participants with UC

Group IV: TEV-48574 Dose A (CD) Experimental Treatment 1 Intervention

Dose regimen A administered by subcutaneous infusion for participants with CD

Group V: Placebo UC Placebo Group 1 Intervention

Matching Placebo

Group VI: 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

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Preclinical development of a bispecific TNFα/IL-23 neutralising domain antibody as a novel oral treatment for inflammatory bowel disease. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Vedolizumab as a Treatment for Crohn's Disease and Ulcerative Colitis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Oral Anti-Tumour Necrosis Factor Domain Antibody V565 Provides High Intestinal Concentrations, and Reduces Markers of Inflammation in Ulcerative Colitis Patients. [2021]

4. Japan pubmed.ncbi.nlm.nih.gov

Ustekinumab Decreases Circulating Th17 Cells in Ulcerative Colitis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Model-Based Investigation of Inadequate Efficacy of Tesnatilimab, an Anti-Natural Killer Group 2 Member D Monoclonal Antibody, in Moderately to Severely Active Crohn Disease. [2023]