A Study of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication.

Phase 1

Conditions: Asthma
MedDRA version: 18.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2013-000176-15-BG

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1050

Inclusion Criteria

- Adult patients, 18-75 years of age at Visit 1
- Asthma diagnosis for >/= 12 months at Visit 1
- Bronchodilator response during screening and at the time of randomization
- Pre-bronchodilator FEV1 of 40% - 80% predicted at both visits 2 and 3
- On inhaled corticosteroid (ICS) therapy at a total daily dose of 500-2000 mcg of fluticasone propionate DPI or equivalent for >/= 6 months prior to Visit 1
- On an eligible second controller medication (LABA, LTRA, LAMA, or theophylline) for 6 months prior to Visit 1
- Uncontrolled asthma as defined by the protocol both during screening and at the time of randomization
- Chest X-ray or computed tomography (CT) scan obtained within 3 months prior to screening or chest x-ray during screening period confirming the absence of other clinically significant lung disease
- Demonstrated adherence with controller medication during the screening period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 950
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
- Maintenance oral corticosteroid therapy within 3 months of Visit 1
- Treatment with systemic (oral, intravenous, or intramuscular) corticosteroids within 4 weeks prior to Visit 1 or during the screening period
- Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or during the screening period or anticipated need for intra-articular corticosteroids during the course of the study
- Infection requiring hospital admission or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening; Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening; Active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
- Active tuberculosis requiring treatment within 12 months prior to Visit 1
- Known immunodeficiency, including, but not limited to, HIV infection
- Evidence of acute or chronic hepatitis or known liver cirrhosis
- History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease
- Known current malignancy or current evaluation for potential malignancy
- Current smoker or former smoker with a history of > 10 pack-years
- History of alcohol or drug abuse
- Past and/or current use of any anti-IL-13 or anti-IL-4/IL-13 therapy, including lebrikizumab; use of other monoclonal antibody therapy, including omalizumab, within 6 months prior to Visit 1
- Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To evaluate the efficacy and safety of lebrikizumab compared with placebo<br>• To evaluate serum periostin level and blood eosinophil count as predictive biomarkers (diagnostic)<br>• To evaluate the efficacy and safety of different dose levels of lebrikizumab compared with placebo<br>;Secondary Objective: To evaluate changes in measures of lung function, time to first asthma exacerbation, rate of urgent asthma-related health care utilization, change in patient-reported asthma-specific outcomes, change in asthma rescue medication use, and change in asthma control during the placebo-controlled period;Primary end point(s): Rate of asthma exacerbations during the 52-week placebo-controlled period<br><br>;Timepoint(s) of evaluation of this end point: 52 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Absolute change in pre-bronchodilator FEV1 (liters)<br>2. Time to first asthma exacerbation<br>3. Change in asthma-specific health related quality of life: overall score of the Standardized Asthma Quality of Life Questionnaire (AQLQ[S])<br>4. Change in asthma rescue medication use<br>5 Absolute change in asthma control, as measured by the Asthma Control Questionnaire-5 (ACQ-5) score<br>6 Rate of urgent asthma-related health care utilization<br>7. Safety: Incidence of adverse events<br>;Timepoint(s) of evaluation of this end point: 1. from baseline at week 52<br>2. 52 weeks<br>3. to 5. from baseline at Week 52<br>6. 52 weeks<br>7. 124 weeks<br>

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