Trials / Terminated
TerminatedNCT04545385
A Study to Test if TEV-48574 is Effective in Relieving Asthma
A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Evaluate the Efficacy and Safety of TEV-48574 in Adults With T2-low/Non-T2 Severe Uncontrolled Asthma
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TEV-48574 | subcutaneous infusion |
| DRUG | Placebo | Matching Placebo |
Timeline
- Start date
- 2020-10-07
- Primary completion
- 2022-01-17
- Completion
- 2022-01-17
- First posted
- 2020-09-11
- Last updated
- 2023-03-13
- Results posted
- 2023-03-13
Locations
97 sites across 5 countries: United States, Bulgaria, Czechia, Germany, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04545385. Inclusion in this directory is not an endorsement.