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

The Effects of IMA-026 on Allergen-Induced Airway Responses and Airway Inflammation in Subjects With Mild Atopic Asthma

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00725582

Enrollment

Registered

2008-07-30

Start date

2008-09-30

Completion date

2009-06-30

Last updated

2009-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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.

Interventions

DRUGIMA-026

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Comparison of the maximum change in FEV1 from baseline for the LAR between IMA-026 and placebo	11 weeks

Secondary

Measure	Time frame
Treatment comparison of the hour 3 and hour 7 FEV1 AUC for the LAR; various comparisons of the methacholine PC20	11 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026