CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
MEDI528 0.3 mg/kg +3 morebiological
Likely dose
MEDI528 0.3 mg/kgfrom 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/NCT00507130
NCT00507130Phase 2Completed

A Phase 2A, Randomized, Double-Blind, Placebo-Controlled,Dose-Escalation Study to Evaluate the Safety and Tolerability of Multiple-Dose Subcutaneous Administration of MEDI-528, A Humanized Anti-Interleukin-9 Monoclonal Antibody,When Administered to Adults With Mild Persistent Asthma

MedImmune LLC·interventional·Posted Jul 25, 2007·Updated Dec 11, 2013

In Brief

A Phase 2 clinical trial evaluating MEDI528 0.3 mg/kg, MEDI528 1 mg/kg, and 2 other interventions for Asthma. Completed, enrolled 36 participants across 9 sites in 2 countries.

Detailed Summary

The primary objective of this study is to evaluate the safety and tolerability of escalating multiple SC doses of MEDI-528 in adult patients with mild persistent asthma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 25, 2007
Enrollment StartJul 1, 2007
Primary CompletionJul 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.9 years ago

Interventions

MEDI528 0.3 mg/kgbiological

MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks

MEDI528 1 mg/kgbiological

MEDI-528 at a dose of 1 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks

MEDI528 3 mg/kgbiological

MEDI-528 at a dose of 3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks

PLACEBOother

Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks