TEV-48574 for Asthma

Phase 2

Waitlist Available

Research Sponsored by Teva Branded Pharmaceutical Products R&D, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization (week 0) until week 24

Summary

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.

Eligible Conditions

Asthma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization (week 0) until week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization (week 0) until week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization (week 0) until week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Who Experienced Loss of Asthma Control (LoAC) During the Treatment Period

Secondary study objectives

Change From Baseline in Asthma Control Questionnaire 6-Question Version (ACQ-6) Score at Week 16

Change From Baseline in Daily Average Use of Short-acting Beta-agonist (SABA) Quick Relief Medication at Week 16

Change From Baseline in Forced Expiratory Flow at 25-75% of Pulmonary Volume (FEF25%-75%) at Week 16

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TEV-48574Experimental Treatment1 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: PlaceboPlacebo Group1 Intervention

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

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