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Study to Evaluate the Safety and Efficacy of CAT-354

NCT00873860 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 357

Last updated 2017-03-24

Study results available
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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.

Conditions

Interventions

OTHER

Placebo

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

BIOLOGICAL

CAT-354 150 mg

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

BIOLOGICAL

CAT-354 300 mg

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

BIOLOGICAL

CAT-354 600 mg

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

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • MedImmune LLC · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Bulgaria
  • Germany
  • Poland
  • Romania
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00873860 on ClinicalTrials.gov