Study Evaluating the Effect of IMA-026 on Allergen-Induced Late Asthma Response in Mild Asthma

Wyeth is now a wholly owned subsidiary of Pfizer24 enrolled

Overview

The purpose of this study is to evaluate the effect of IMA-026, an antibody to IL-13, on airway hyperresponsiveness and airway inflammation in mild asthmatics. IMA-026 will be given as 2 injections under the skin 1 week apart at 2 mg/kg each dose. The study will include a screening period and a treatment period which includes doses on day 1 and day 8.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Asthma

Interventions

IMA-026DRUG

PlaceboOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy men and women 18 to 60 yrs with mild allergic asthma 2. only asthma med is short-acting bronchodilator used not more than twice weekly 3. FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction Exclusion Criteria: 1. Upper respiratory infection or asthma exacerbation with 4 weeks of screening 2. Serious infection requiring parenteral antibiotics or hospitalization with 4 weeks of test article administration 3. Positive radiographic findings indicative of respiratory disease other than asthma

Outcomes

Primary Outcomes

Comparison of the maximum change in FEV1 from baseline for the LAR between IMA-026 and placebo

Time frame: 11 weeks

Secondary Outcomes

Treatment comparison of the hour 3 and hour 7 FEV1 AUC for the LAR; various comparisons of the methacholine PC20

Time frame: 11 weeks

Data from ClinicalTrials.gov

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