Study Complete
Sponsor ID
D5180C00037

Study to Evaluate Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe AsthmaWAYFINDER

Sponsor ID
D5180C00037
Clinicaltrials.gov ID
NCT05274815
EUCTIS ID
N/A
EudraCT ID
2021-005457-85

Study Details

This is a study designed to evaluate efficacy and safety of Tezepelumab in reducing oral corticosteroid use in adult patients with severe asthma who are receiving oral corticosteroids with or without additional asthma controller medications.

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
N/A
Enrollment
305
Additional Study Details

Protocol Summary

Primary Outcome Measures

Proportion of the Participants Who Discontinued OCS Without Loss of Asthma Control at Week 28 and Week 52

Timeframe: Week 28 and Week 52

Proportion of the Participants Who Reduced Daily Prescribed Maintenance OCS Dose to ≤5 mg/Day Without Loss of Asthma Control at Week 28 and Week 52

Timeframe: Week 28 and Week 52

Secondary Outcome Measures

Annual Asthma Exacerbation Rate (AAER) Over Week 28 and Over Week 52

Timeframe: Week 28 and Week 52

Rate of Asthma Exacerbation Associated With Hospitalisation or ER Visit Over 28 Weeks and Over 52 Weeks

Timeframe: Week 28 and Week 52

Rate of Asthma Exacerbation Associated With Hospitalisation Over 28 Weeks and Over 52 Weeks

Timeframe: Week 28 and Week 52

Proportion of the Participants Who Did Not Experience an Exacerbation Over 28 Weeks and Over 52 Weeks

Timeframe: Week 28 and Week 52

Proportion of the Participants Who Did Not Experience an Exacerbation Associated With Hospitalisation or ER Visit Over 28 Weeks and Over 52 Weeks

Timeframe: Week 28 and Week 52

Proportion of the Participants Who Did Not Experience an Exacerbation Associated With Hospitalisation Over 28 Weeks and Over 52 Weeks

Timeframe: Week 28 and Week 52

Proportion of the Participants With ≥50% Reduction From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52

Timeframe: Week 28 and Week 52

Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 and Week 52

Timeframe: Week 28 and Week 52

Absolute Change From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52

Timeframe: Week 28 and Week 52

Percent Change From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52

Timeframe: Week 28 and Week 52

Change From Baseline in Post-bronchodilator FEV1 at Week 28 and Week 52

Timeframe: Week 28 and Week 52

Change From Baseline in ACQ-6 at Week 28 and Week 52

Timeframe: Week 28 and Week 52

Change From Baseline in Standardised AQLQ(s)+12 Total Score at Week 28 and Week 52

Timeframe: Week 28 and Week 52

Change From Baseline in SGRQ Total Score at Week 28 and Week 52

Timeframe: Week 28 and Week 52

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
Newark, Delaware, United States, 19713
Status
N/A
Location
Research Site
Loxahatchee Groves, Florida, United States, 33470
Status
N/A
Location
Research Site
Ann Arbor, Michigan, United States, 48109
Status
N/A
Location
Research Site
Toms River, New Jersey, United States, 08755
Status
N/A
Location
Research Site
The Bronx, New York, United States, 10467
Status
N/A
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