This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, interventional trial in participants with an acute asthma exacerbation with type 2 inflammation to compare rademikibart plus standard therapy to standard therapy alone (plus placebo), targeting an acute asthma exacerbation in the urgent healthcare setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.
Treatment failure rate within 28 days after randomization
Treatment failure is defined as death due to any cause, (re)admission to a hospital for asthma, ED (re)visit or unscheduled medical visit for worsening of asthma symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for asthma exacerbation) within 28 days after randomization.
Time frame: 28 days
Absolute change from baseline (CFB) in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 1
Time frame: Week 1
Rate of new asthma exacerbations in the 28 days after randomization
Time frame: 28 days
Time to the first new asthma exacerbation in the 28 days after randomization
Time frame: 28 days
Mean CFB in morning/evening asthma symptom score
Time frame: Week 1, Week 2, and Week 4
Mean CFB in nocturnal awakenings (e-diary)
Time frame: Week 1, Week 2, and Week 4
Absolute CFB in post-BD FEV1
Time frame: Day 3 and Week 4
Incidence of adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESIs), and drug-induced liver injury (DILI) reported
Time frame: 56 days
Incidence of unanticipated adverse device effects (UADEs)
Time frame: 56 days
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Leland Stanford Junior University, Stanford Hospital
Palo Alto, California, United States
Amicis Research Center
Valencia, California, United States
Nemours Children's Hospital - DE
Wilmington, Delaware, United States
Nemours Children's Health
Jacksonville, Florida, United States
Pharmax Research of South Florida, Inc.
Miami, Florida, United States
Columbus Clinical Services, LLC
Miami, Florida, United States
Nemours Children's Health, Lake Nona
Orlando, Florida, United States
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, United States
Primeway Clinical Research Group
Fayetteville, Georgia, United States
Pivotal Research Solutions
Stonecrest, Georgia, United States
...and 48 more locations
Incidence of injection site reactions
Time frame: 56 days