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Monoclonal Antibodies
A Study to Test if TEV-48574 is Effective in Relieving 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
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 moreTrial 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TEV-48574
2022
Completed Phase 2
~290
Find a Location
Who is running the clinical trial?
Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
256 Previous Clinical Trials
3,486,399 Total Patients Enrolled
64 Trials studying Asthma
2,616,878 Patients Enrolled for Asthma
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
97 Previous Clinical Trials
39,612 Total Patients Enrolled
23 Trials studying Asthma
13,307 Patients Enrolled for Asthma