A Study to Evaluate MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma

A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00781443

Enrollment

Registered

2008-10-29

Start date

2008-12-31

Completion date

Unknown

Last updated

2010-05-06

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

Conditions

Allergic Asthma

Keywords

Asthma

Brief summary

This is a multicenter, randomized, double-blind, placebo-controlled study designed to demonstrate the safety and efficacy of MILR1444A compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult patients with mild allergic asthma. The study will randomize approximately 24 patients at five study centers. In the event of patient discontinuation from the study, additional patients may be enrolled at the discretion of the Sponsor.

Interventions

DRUGlebrikizumab (MILR1444A)

Repeating subcutaneous injection

DRUGplacebo

Repeating subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Meet criteria for the diagnosis of allergic asthma * Diagnosis of asthma ≥ 6 months * Currently treated with only intermittent short-acting inhaled β-adrenergic agonists * Body weight between 40-120 kg * Normal chest X-ray within 2 years of screening

Exclusion criteria

* Require daily controller medication for asthma * History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to MILR1444A (e.g., monoclonal antibodies, polyclonal gamma globulin) * Documented medical history of anaphylaxis * Immunotherapy currently or within the past 3 months prior to screening * Lung disease other than mild allergic asthma * Previous treatment with other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer * Pregnant or lactating * Significant concurrent medical illness other than asthma * Clinically significant abnormality on ECG at the screening visit * Smoked in the previous 6 months or have a history of smoking more than 10 pack-years * History of helminthic infection

Design outcomes

Primary

Measure	Time frame
Late asthmatic response (LAR)	Day 92

Secondary

Measure	Time frame
Early asthmatic response (EAR)	Day 92

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026