CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 335 enrolled
Drug / intervention
Mepolizumab +1 morebiological
Likely dose
Mepolizumab 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03292588
NCT03292588Phase 2Completed
CompareCT.gov

Mechanisms Underlying Asthma Exacerbations Prevented and Persistent With Immune-Based Therapy: A Systems Approach Phase 2 (ICAC-30)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Sep 25, 2017·Updated Jul 20, 2022

In Brief

A Phase 2 clinical trial evaluating Mepolizumab and Placebo for Asthma. Completed, enrolled 335 participants across 9 sites.

Detailed Summary

The purpose of this study is to see if treatment with a medication called Nucala® (mepolizumab), given along with standard asthma care, makes children less likely to have asthma attacks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
CollaboratorsInner-City Asthma Consortium, GlaxoSmithKline, Rho Federal Systems Division, Inc.

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedSep 25, 2017
Enrollment StartNov 7, 2017
Primary CompletionApr 20, 2021
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 8.8 years ago

Interventions

Mepolizumabbiological

Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.

Placebodrug

Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.