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

Teva Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Asthma

Treatments: Drug: TEV-48574; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04545385

TV48574-AS-20031

2020-001927-15 (EudraCT Number)

Details and patient eligibility

About

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 participants 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 participant participation in the study is planned to be up to approximately 30 weeks.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups, including a placebo group

TEV-48574

Experimental group

Description:

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).

Treatment:

Drug: TEV-48574

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo