Trials / Terminated
TerminatedNCT04847674
A Study to Test if TEV-53275 is Effective in Relieving Asthma
A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Safety, Efficacy and Pharmacodynamics of TEV 53275 Administered Subcutaneously in Adult Patients With Persistent Eosinophilic Asthma
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 97 (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 efficacy of TEV-53275 administered subcutaneously (sc) in adult participants with persistent asthma and an eosinophilic phenotype compared to placebo. A secondary objective is to evaluate the efficacy of TEV-53275 compared to placebo assessed by lung function, asthma symptoms, rescue medication use, and quality of life measures. Another secondary objective is to evaluate the safety and tolerability of TEV-53275 administered sc in adult participants with persistent asthma and an eosinophilic phenotype compared with placebo, and lastly, to evaluate the immunogenicity of TEV-53275 administered sc in adult participants with persistent asthma and an eosinophilic phenotype.
Detailed description
The planned study duration is approximately 16 months. The total duration of study participation is approximately 34 weeks including up to a 2-week screening period, a 2-week run-in period, a 16-week treatment period, and a follow-up visit 14 weeks after the final treatment visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TEV-53275 Dose A | subcutaneous (sc) injection |
| DRUG | TEV-53275 Dose B | subcutaneous (sc) injection |
| DRUG | Placebo | Matching subcutaneous (sc) placebo injection |
Timeline
- Start date
- 2021-05-04
- Primary completion
- 2022-04-28
- Completion
- 2022-04-28
- First posted
- 2021-04-19
- Last updated
- 2023-06-08
- Results posted
- 2023-06-08
Locations
82 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04847674. Inclusion in this directory is not an endorsement.