NCT00781443CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Genentech, Inc.
- Enrollment
- 29
- Primary Endpoint
- Late asthmatic response (LAR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A
Experimental
Intervention: lebrikizumab (MILR1444A) (Drug)
B
Placebo Comparator
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Late asthmatic response (LAR)
Time Frame: Day 92
Secondary Outcomes
- Early asthmatic response (EAR)(Day 92)
Investigators
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