Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main purpose of study is to assess the safety, tolerability, and pharmacokinetic (PK) of benralizumab.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:
⁃ All Cohorts:
• Male or female patients must be aged 6 to \< 18 years of age at the time of signing the assent form and their caregiver signing the informed consent form.
• Body weight greater than (\>=) 15 kilograms (kg).
⁃ EGPA Cohort:
• Therapy with corticosteroids: The prescribed dose of oral corticosteroids (OCS) (greater than \[\>\] 0.1 milligrams per kilogram per day (mg/kg/day), max dose of 50 milligrams per day (mg/day) must be stable (that is, no adjustment of the dose) for at least 4 weeks prior to baseline (Visit 2).
• Immunosuppressive therapy: If receiving immunosuppressive therapy, the dosage must be stable for at least 4 weeks prior to baseline (Visit 2).
Locations
United States
Colorado
Research Site
RECRUITING
Aurora
Other Locations
Brazil
Research Site
RECRUITING
São Paulo
Canada
Research Site
RECRUITING
Toronto
Mexico
Research Site
RECRUITING
Guadalajara
Turkey
Research Site
NOT_YET_RECRUITING
Altındağ
Research Site
RECRUITING
Istanbul
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date:2025-04-17
Estimated Completion Date:2027-12-29
Participants
Target number of participants:14
Treatments
Experimental: EGPA Cohort: Benralizumab
Participants with greater than or equal to (\>=) 35 kg weight will receive benralizumab dose-1 and participants with less than (\<) 35 kg weight will receive benralizumab dose-2 as SC injection Q4W during the 52-week treatment period. All participants, who complete the 52-week treatment period, will be offered the opportunity to continue into an extension period.