Terminated/Withdrawn
Sponsor ID
20220093
A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma
Study Details
The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.
Protocol Summary
Primary Outcome Measures
Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period
Timeframe: Up to Week 48
Secondary Outcome Measures
Annualized Asthma Exacerbation Rate (AAER)
Timeframe: Up to Week 48
Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)
Timeframe: Baseline and Week 48
Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48
Timeframe: Baseline and Week 48
Change From Baseline in Pre-BD FEV1
Timeframe: Baseline and Week 56
Change From Baseline in Asthma Symptom Diary (ASD) Score
Timeframe: Baseline and Week 48
Number of Participant Achieving ACQ-6 Response at Week 48
Timeframe: Week 48
Change From Baseline in ACQ-6
Timeframe: Baseline and Week 48
Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score
Timeframe: Baseline, Weeks 12, 24, 36 and 48
Number of Participants Achieving AQLQ (S) Response at Week 48
Timeframe: Week 48
Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period
Timeframe: Up to Week 48
Time to First Asthma Exacerbation Event
Timeframe: Up to 62 weeks
Time to First CompEx Event
Timeframe: Up to Week 48
Number of Participants with a CompEx Event During the Double Blinded Treatment Period
Timeframe: Up to Week 48
Annualized Rate of CompEx Events
Timeframe: Up to Weeks 12, 24 and 36
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels
Timeframe: Baseline and Week 56
Serum Rocatinlimab Concentrations
Timeframe: Up to 56 weeks
Trough Concentration (Ctrough) of Rocatinlimab
Timeframe: Up to 56 weeks
Locations
Location
Allergy and Asthma Clinical Research
Walnut Creek, CA, United States, 94598
Status
Recruiting
Location
Bernstein Clinical Research Center LLC
Cincinnati, OH, United States, 45236
Status
Recruiting
Location
Pioneer Research Solutions Inc
Sugar Land, TX, United States, 77479
Status
Recruiting
Location
AllerVie Clinical Research- Columbus
Columbus, GA, United States, 31904
Status
Recruiting
Location
The Allergy Asthma and Sinus Center
Knoxville, TN, United States, 37909
Status
Recruiting
Location
Family Allergy and Asthma Research Institute
Louisville, KY, United States, 40217
Status
Recruiting
Showing {first} - {last} of {total} Results