TEV-48574 for Inflammatory Bowel Disease

Recruiting at 124 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: 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

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called TEV-48574, given as a shot periodically, in adults with inflammatory bowel disease. It aims to see how well the drug works, how safe it is, and how the body reacts to it.

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.

What data supports the effectiveness of the drug TEV-48574 for treating Inflammatory Bowel Disease?

Research on similar treatments, like V565 and AVX-470, shows that drugs targeting tumor necrosis factor (TNF) can reduce inflammation in the intestines of patients with ulcerative colitis, a type of inflammatory bowel disease. These drugs work by neutralizing TNF, a protein that contributes to inflammation, suggesting that TEV-48574 might have similar benefits. ^{1 2 3 4 5}

Research Team

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Eligibility Criteria

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 Any woman becoming pregnant during the study will be withdrawn from the study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

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

Treatment Details

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.

Participant Groups

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, 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

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]

References

1. 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]

2. England 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. [2017]

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

Antitumor Necrosis Factor-like Ligand 1A Therapy Targets Tissue Inflammation and Fibrosis Pathways and Reduces Gut Pathobionts in Ulcerative Colitis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

AVX-470, an Orally Delivered Anti-Tumour Necrosis Factor Antibody for Treatment of Active Ulcerative Colitis: Results of a First-in-Human Trial. [2017]

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

EW-7197 prevents ulcerative colitis-associated fibrosis and inflammation. [2020]