A Study to Test if TEV-53275 is Effective in Relieving Asthma

Recruiting at 85 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.

Must be taking: Inhaled corticosteroids, LABA

Must not be taking: Monoclonal antibodies, Immunosuppressives

Disqualifiers: Life-threatening asthma, Eosinophilic conditions, Infections, Smoking, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

97 Participants Needed

Trial Summary

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.

What safety data exists for TEV-53275 (AMG 531) in humans?

AMG 531, also known as TEV-53275, was generally well-tolerated in studies with healthy subjects and patients with immune thrombocytopenic purpura. Most side effects were mild or moderate, with headache being the most common. However, two patients experienced serious side effects, including severe headache and changes in blood enzyme levels. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tests a new injection called TEV-53275 for adults with a specific type of asthma that doesn't respond well to usual treatments. The medication works by lowering certain white blood cells to help improve breathing and reduce symptoms.

Research Team

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Eligibility Criteria

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.

Timeline

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

Treatment Details

Interventions

• TEV-53275

Participant Groups

Group I: TEV-53275 Dose B Experimental Treatment 1 Intervention

Group II: TEV-53275 Dose A Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

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

References

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

Pharmacodynamics and pharmacokinetics of AMG 531, a novel thrombopoietin receptor ligand. [2016]

2. England pubmed.ncbi.nlm.nih.gov

An open-label, unit dose-finding study of AMG 531, a novel thrombopoiesis-stimulating peptibody, in patients with immune thrombocytopenic purpura. [2016]

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

Phase 1 clinical study of eltrombopag, an oral, nonpeptide thrombopoietin receptor agonist. [2021]

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

PEGylated thrombopoietin mimetic, JNJ‑26366821 a novel prophylactic radiation countermeasure for acute radiation injury. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A novel and simple hollow-fiber assay for in vivo evaluation of nonpeptidyl thrombopoietin receptor agonists. [2016]