Terminated/Withdrawn
Sponsor ID
20220093

A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma

Sponsor ID
20220093
Clinicaltrials.gov ID
NCT06376045
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.

Additional Study Details

Phase
Phase 2
Product
Rocatinlimab
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
317
Additional Study Details

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
Status
Contact Us
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
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