Terminated/Withdrawn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
NCT05398263
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

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
N/A
Enrollment
125
Additional Study Details

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
Status
Contact Us
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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