CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 357 enrolled
Drug / intervention
CAT-354 150 mg +3 morebiological
Likely dose
CAT-354 150 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/NCT00873860
NCT00873860Phase 2Completed

A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Parallel-Arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), on Asthma Control in Adults With Uncontrolled, Moderate-to-severe, Persistent Asthma

MedImmune LLC·interventional·Posted Apr 2, 2009·Updated Mar 24, 2017

In Brief

A Phase 2 clinical trial evaluating Placebo, CAT-354 150 mg, and 2 other interventions for Asthma. Completed, enrolled 357 participants across 57 sites in 5 countries.

Detailed Summary

This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm study to evaluate the efficacy and safety of 3 subcutaneous (SC) treatment regimens of CAT-354 in adult subjects with uncontrolled, moderate-to-severe, persistent asthma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBulgaria, Germany, Poland, Romania, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2, 2009
Enrollment StartJun 1, 2009
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.3 years ago

Interventions

Placeboother

Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

CAT-354 150 mgbiological

CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

CAT-354 300 mgbiological

CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

CAT-354 600 mgbiological

CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.