A Study to Test if TEV-48574 is Effective in Relieving Asthma

Recruiting at 98 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, Long-acting beta-agonists

Disqualifiers: Pregnancy, Lactation, Recent vaccines, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

65 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that any treatments that could interfere with the study are excluded, so it's best to discuss your specific medications with the study investigator.

What is the purpose of this trial?

This trial is testing a new medication called TEV-48574 to help adults with severe asthma that doesn't improve with standard treatments. The medication aims to reduce inflammation and other factors causing asthma symptoms, making it easier to breathe and reducing asthma attacks.

Research Team

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Eligibility Criteria

Inclusion Criteria

The participant is able to perform technically acceptable and repeatable spirometry, including with a hand-held spirometer, after training

The participant has had at least one documented clinical asthma exacerbation in the 18 months prior to (but not within 30 days of) the initial screening visit.

The participant is a non-smoker for ≥6 months with lifetime history ≤10 pack-years, with no current ecigarette or marijuana use.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TEV-48574 or placebo every 2 weeks for a total of 8 doses over 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• TEV-48574

Participant Groups

Group I: TEV-48574 Experimental Treatment 1 Intervention

Participants will receive the investigational medicinal product (IMP) loading doses on the day of randomization and the subsequent corresponding IMP maintenance doses every 2 weeks for a total of 8 doses (1 loading dose and 7 maintenance doses).

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo matching to TEV-48574 SC every 2 weeks for a total of 8 doses.

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