A Study to Test if TEV-53275 is Effective in Relieving Asthma
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|ClinicalTrials.gov Identifier: NCT04847674|
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : November 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: TEV-53275 Dose A Drug: TEV-53275 Dose B Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||April 6, 2021|
|Estimated Primary Completion Date :||July 2, 2022|
|Estimated Study Completion Date :||July 30, 2022|
|Experimental: TEV-53275 Dose A||
Drug: TEV-53275 Dose A
subcutaneous (sc) injection
|Experimental: TEV-53275 Dose B||
Drug: TEV-53275 Dose B
subcutaneous (sc) injection
|Placebo Comparator: Placebo||
Matching subcutaneous (sc) placebo injection
- Change from baseline in morning Forced Expiratory Volume in 1 Second (FEV1). [ Time Frame: Baseline, Week 12 ]FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. FEV1 was defined as the predose trough morning percent predicted FEV1 measurement at the randomization visit (Baseline [Day 1]) at the investigational center.
- Percentage of asthma control weeks [ Time Frame: Week 1, Week 12, Week 16 ]
- Change from baseline in weekly average of daily morning trough (pre-rescue bronchodilator) FEV1 [ Time Frame: Baseline, Week 12, Week 16 ]
- Change from baseline in weekly average of rescue medication use [ Time Frame: Baseline, Week 12, Week 16 ]
- Change from baseline in percentage of asthma control days (no symptoms and no rescue medication use) [ Time Frame: Baseline, Week 12, Week 16 ]
- Time to first clinical asthma exacerbation (CAE) [ Time Frame: Week 30 ]
- Change from baseline in Asthma Control Questionnaire (ACQ-6) [ Time Frame: Baseline, Week 12, Week 16 ]Six questions are self-assessments (completed by the participant). Each item on the ACQ-6 has a possible score ranging from 0 to 6 (0=no impairment; 6=maximum impairment), and the total score is the mean of all responses.
- Change from baseline in Asthma Control Test (ACT) [ Time Frame: Baseline, Week 12, Week 16 ]A participant self-administered tool for identifying those with poorly controlled asthma comprising 5 items. Total scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control.
- Change from baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) [ Time Frame: Baseline, Week 12, Week 16 ]The questionnaire is a tool to measure the impact of asthma on a participant's quality of life (physical, emotional, social, and occupational). The questionnaire contains 32 items with a 2-week recall period and uses a 7-point Likert scale (7=not impaired at all to 1=severely impaired). Scores range from 1 to 7, with higher scores indicating better quality of life.
- Proportion of participants who achieve FEV1:FVC (forced vital capacity) ratio ≥0.80 [ Time Frame: Week 12, Week 16 ]
- Number of participants reporting at least one adverse event [ Time Frame: Week 30 ]Adverse events will include clinically significant laboratory test results (serum chemistry, hematology, and urinalysis), vital signs, 12-lead electrocardiogram (ECG) results, and injection site reactions.
- Number of participants who reported use of concomitant medications [ Time Frame: Week 30 ]
- Number of participants developing antidrug antibodies (ADAs) throughout the study [ Time Frame: Week 30 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04847674
|Contact: Teva U.S. Medical Information||1-888-483-8279||USMedInfo@tevapharm.com|
|Study Director:||Teva Medical Expert, MD||Teva Branded Pharmaceutical Products R&D, Inc.|