Terminated/Withdrawn
Sponsor ID
D5180C00024
Tezepelumab Efficacy and Safety in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent AsthmaSUNRISE
Sponsor ID
D5180C00024
Clinicaltrials.gov ID
EUCTIS ID
2023-504648-33
EudraCT ID
2021-006691-17
Study Details
A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled 28-week Phase 3 Efficacy and Safety Study of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma
Protocol Summary
Primary Outcome Measures
Proportion of Subjects by Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 Whilst Maintaining Asthma Control.
Timeframe: Baseline to Week 28
Secondary Outcome Measures
Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) at Week 28
Timeframe: Baseline to Week 28
Proportion of Subjects With 100% Reduction From Baseline in Daily OCS Dose at Week 28
Timeframe: Baseline to Week 28
Proportion of Subjects With Daily OCS Dose ≤5 mg at Week 28
Timeframe: Week 28
Proportion of Subjects With ≥50% Reduction From Baseline in Daily OCS Dose at Week 28
Timeframe: Baseline to Week 28
Annualised Asthma Exacerbation Rate (AAER) Over 28 Weeks
Timeframe: Baseline to Week 28
Proportion of Subjects With >= 1 Asthma Exacerbation
Timeframe: Baseline to Week 28
Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 28
Timeframe: Baseline to Week 28
Change From Baseline in Weekly Mean Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 28
Timeframe: Baseline to Week 28
Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(s)+12) Total Score at Week 28
Timeframe: Baseline to Week 28
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Score at Week 28
Timeframe: Baseline to Week 28
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 28
Timeframe: Baseline to Week 28
Change From Baseline in Peripheral Blood Eosinophils at Week 28
Timeframe: Baseline to Week 28
Change From Baseline in Total Serum Immunoglobulin E (IgE) at Week 28
Timeframe: Baseline to Week 28
PK: Serum Trough Concentrations at Week 0, 12 and 28
Timeframe: Baseline, Week 12 and Week 28
Immunogenicity: Incidence of Anti-drug Antibodies (ADA) at Week 0, 12, 28, and 40
Timeframe: Baseline to Week 40
Study Documents
Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Locations
Location
Research Site
Newport Beach, California, United States, 92663
Status
N/A
Location
Research Site
Denver, Colorado, United States, 80206
Status
N/A
Location
Research Site
Newark, Delaware, United States, 19713
Status
N/A
Location
Research Site
Hialeah, Florida, United States, 33016
Status
N/A
Location
Research Site
Miami Lakes, Florida, United States, 33014
Status
N/A
Location
Research Site
Lincoln, Nebraska, United States, 68510
Status
N/A
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