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

• Status: Recruiting
• Trial end date: 2022-08-17
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to evaluate the effect of TEV-48574 compared with placebo on loss of asthma control (LoAC) in adult patients with T2-low and non-T2 severe asthma uncontrolled on inhaled corticosteroids plus long-acting beta-agonists (ICS+LABA).

The secondary efficacy objective is to evaluate the effect of TEV-48574 compared with placebo on a range of clinical measures of asthma control.

The duration of patient participation in the study is planned to be up to approximately 30 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Criteria

Inclusion Criteria:

• The participant has a diagnosis of asthma for at least 12 months prior to the initial screening visit.

• 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.

NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

• The participant has any concomitant conditions or treatments that could interfere with study conduct.

• The participant is currently pregnant or lactating or is planning to become pregnant during the study.

• The participant has received any live or attenuated vaccine within 15 days of the initial screening visit.

NOTE- Additional criteria apply, please contact the investigator for more information