The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
317
Rocatinlimab will be administered by SC injection.
Placebo will be administered by SC injection.
Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period
Time frame: Up to Week 48
Annualized Asthma Exacerbation Rate (AAER)
Time frame: Up to Week 48
Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline and Week 48
Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48
Time frame: Baseline and Week 48
Change From Baseline in Pre-BD FEV1
Time frame: Up to 62 weeks
Change From Baseline in Asthma Symptom Diary (ASD) Score
Time frame: Up to Week 48
Number of Participant Achieving ACQ-6 Response at Week 48
Time frame: Week 48
Change From Baseline in ACQ-6
Time frame: Up to Week 48
Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score
Time frame: Baseline, Weeks 12, 24, 36 and 48
Number of Participants Achieving AQLQ (S) Response at Week 48
Time frame: Up to Week 48
Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period
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Kern Research Inc
Bakersfield, California, United States
Orso Health Inc
La Jolla, California, United States
Imax Clinical Trials
La Palma, California, United States
Antelope Valley Clinical Trials
Lancaster, California, United States
Downtown Los Angeles Research Center, Inc
Los Angeles, California, United States
NewportNativeMD, Inc
Newport Beach, California, United States
University of California Irvine
Orange, California, United States
Apex Clinical Research
San Diego, California, United States
Allergy and Asthma Clinical Research
Walnut Creek, California, United States
Allianz Research Institute Westminster
Westminster, California, United States
...and 144 more locations
Time frame: Up to Week 48
Time to First Asthma Exacerbation Event
Time frame: Up to 62 weeks
Time to First CompEx Event
Time frame: Up to 62 weeks
Number of Participants with a CompEx Event During the Double Blinded Treatment Period
Time frame: Up to Week 48
Annualized Rate of CompEx Events
Time frame: Weeks 12, 24 and 36
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels
Time frame: Up to 62 weeks
Serum Rocatinlimab Concentrations
Time frame: Up to 62 weeks
Trough Concentration (Ctrough) of Rocatinlimab
Time frame: Up to 62 weeks
Number of Participants with Treatment-emergent Adverse Events
Time frame: Up to 62 weeks
Number of Participants with Serious Adverse Events
Time frame: Up to 62 weeks
Number of Participants with Anti-rocatinlimab Antibody Formation
Time frame: Up to 62 weeks