TEV-53275 for Asthma

No longer recruiting at 88 trial locations
TU
Overseen ByTeva U.S. Medical Information
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Must be taking: Inhaled corticosteroids, LABA
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment, TEV-53275, can relieve asthma symptoms in adults with ongoing asthma involving eosinophils, a type of white blood cell. Researchers will compare TEV-53275 to a placebo (a harmless pill with no active drug) to assess its effects on lung function, asthma symptoms, and quality of life. The trial will also evaluate the treatment's safety and any unusual body reactions. It suits adults who have had asthma for at least six months and have remained stable on their current asthma medications without flare-ups for the past month. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify that you need to stop taking your current asthma medications. In fact, it mentions that participants should be able to continue their current asthma maintenance medications throughout the study.

Is there any evidence suggesting that TEV-53275 is likely to be safe for humans?

Research has shown that TEV-53275, a new treatment tested for asthma, presents some safety concerns. Most side effects observed in studies were mild or moderate, with headaches being the most common. However, a few participants experienced serious side effects, including severe headaches. While many people tolerate the treatment well, some may face risks. Anyone considering joining a trial should discuss these potential side effects with their doctor.12345

Why do researchers think this study treatment might be promising for asthma?

Unlike traditional asthma treatments like inhaled corticosteroids and bronchodilators, TEV-53275 is unique because it introduces a new approach by targeting specific pathways involved in asthma's inflammatory process. Researchers are excited about TEV-53275 because it may offer more precise control over asthma symptoms with potentially fewer side effects. The treatment comes in two experimental doses, Dose A and Dose B, allowing researchers to evaluate the most effective dose for relief. This novel approach could mean faster symptom relief and improved quality of life for asthma patients.

What evidence suggests that TEV-53275 might be an effective treatment for persistent asthma?

Research has shown that TEV-53275 may benefit individuals with a type of asthma that doesn't respond well to regular treatments. In earlier studies, patients who received TEV-53275 experienced better lung function and fewer asthma symptoms compared to those who received a placebo (a harmless, inactive substance). These studies also found that patients required less rescue medication, used when asthma symptoms suddenly worsen. In this trial, participants will receive either TEV-53275 at different doses or a placebo. The treatment is administered as an injection under the skin and is being tested for its safety and tolerability. Overall, early results suggest that TEV-53275 could be a promising option for managing persistent asthma involving certain white blood cells.12346

Who Is on the Research Team?

TM

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

The participant has a diagnosis of asthma for at least 6 months and has been stable without exacerbation or change in medications for at least 1 month..
medium or high dose inhaled corticosteroids (ICS)±another controller.
any fixed dose combination ICS (low, medium, or high) with long-acting beta agonist (LABA)±another controller.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Run-in

Participants undergo a 2-week run-in period to stabilize their condition before treatment

2 weeks

Treatment

Participants receive TEV-53275 or placebo subcutaneously for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • TEV-53275
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: TEV-53275 Dose BExperimental Treatment1 Intervention
Group II: TEV-53275 Dose AExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Teva Branded Pharmaceutical Products R&D, Inc.

Lead Sponsor

Trials
258
Recruited
3,487,000+
Dr. Eric Hughes profile image

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 profile image

Richard Francis

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Executive Officer since 2022

Bachelor's degree in Biochemistry from the University of Manchester

Citations

A Study to Test if TEV-53275 is Effective in Relieving AsthmaThe primary objective of the study is to evaluate the efficacy of TEV-53275 administered subcutaneously (sc) in adult participants with persistent asthma ...
A Study to Test if TEV-53275 is Effective in Relieving AsthmaThis trial tests a new injection called TEV-53275 for adults with a specific type of asthma that doesn't respond well to usual treatments.
A Study to Test if TEV-53275 is Effective in Relieving AsthmaA secondary objective is to evaluate the efficacy of TEV-53275 compared to placebo assessed by lung function, asthma symptoms, rescue medication ...
Varokibart - Drug Targets, Indications, Patents... Efficacy and Pharmacodynamics of TEV 53275 Administered Subcutaneously in Adult Patients With Persistent Eosinophilic Asthma. 100 Clinical Results associated ...
A Study to Test if TEV-53275 is Effective in Relieving AsthmaA secondary objective is to evaluate the efficacy of TEV-53275 compared to placebo assessed by lung function, asthma symptoms, rescue medication ...
A study of TEV-53275 given by subcutaneous (under the skin ...A research study is testing an investigational drug in adult patients with eosinophilic-type asthma. The research study will also look at safety of the ...
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