A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF LEBRIKIZUMAB (MILR1444A)IN ADULT PATIENTS WITH ASTHMA WHO ARE INADEQUATELY CONTROLLED ON INHALED CORTICOSTEROIDS. - MILLY

• Conditions: Asthma in patients who are inadequately controlled by inhaled corticosteroids; MedDRA version: 9.1Level: PTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2009-010359-28-CZ
• Lead Sponsor: Genentech, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-02
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Patients must meet the following criteria to be eligible for study entry:

103 Age=18 to = 65 years at Visit 1.

105 Chest radiography within 12 months of visit 1 with evidence of clinically significant abnormality.

107 Uncontrolled asthma defined by all of the following criteria:
- Diagnosis of asthma >12 months.
- Bronchodilator response at Visit 1 or 2
- Pre-bronchodilator FEV1 = 40% and = 80% predicted at Visit 3
- Required daily use of ICS = 200 µg and = 1000 µg total daily dose of fluticasone propionate or equivalent for a minimum of 6 months prior to Visit 1
- Demonstrated on-going asthma symptoms assessed at the end of the run-in period by ACQ score = 1.5 (for symptoms over the 7 days prior to visit 3) despite ICS compliance.

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from study entry:

a. Medical Conditions
201 Asthma exacerbation, significant airflow obstruction, or respiratory infection between visits 1 and 3.

202 Known malignancy or current evaluation for a potential malignancy. If treatment for a malignancy was completed at least 12 months prior to Visit 1 and no further treatment is anticipated by the patient’s oncologist during this study, then the patient may enroll.

203 Basal or squamous cell carcinoma without documention of adequate treatment.

204 Known immunodeficiency, including but not limited to HIV infection.

205 Pre-existing lung disease other than asthma, including active infections.

206 Clinically significant medical disease which is uncontrolled despite treatment or is likely in the opinion of the investigator to require a change in therapy during the study.
207 Patients with elevated IgE levels for reasons other than allergy (including but not limited to parasitic infections, hyperimmunoglobulin E syndrome, and Wiskott-Aldrich, Syndrome).

b. Exposures
210 Current smoker or former smoker with a lifetime smoking history of > 10 pack years.

211 History of substance abuse that may impair or risk the patient’s full participation in the study in the judgment of the investigator.

212 Participation in another interventional clinical trial (including a trial of an approved drug or an interventional study that does not include medication) within 30days or 5 halv-lives if the investigational agent, whichever is longer.

c.Medications
213 Prior allergic reaction during the use (or possible use if blinded study) of a monoclonal antibody.

214 See excluded concomitant and previously prescribed therapies in Table 1 of the protocol.

d.Reproductive Potential
215 Patients (males and females) of reproductive potential who are not willing to use a highly effective method of contraception for the duration of the study or are pregnant or lactating at the time of randomization.

216 Women who are pregnant as documented by a positive serum pregnancy test (at Visit 1) or a urine pregnancy test (at Visit 3, prior to random allocation)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objectives for this study are as follows:<br><br>- To assess the efficacy of lebrikizumab in improving asthma control in patients with asthma who remain inadequately controlled despite therapy with Inhaled corticosteroids (ICS).<br><br>- To evaluate the safety of lebrikizumab in patients with asthma who remain inadequately controlled despite therapy with ICS.;Secondary Objective: The secondary objectives of this study are as follows:<br><br>- To assess the efficacy of lebrikizumab in improving asthma control in patients with asthma who remain inadequately controlled despite therapy with ICS.<br><br>- To assess the efficacy of lebrikizumab in reducing the rate of exacerbations in patients with asthma who remain inadequately controlled despite therapy with ICS<br>;Primary end point(s): The primary efficacy outcome measure is the relative change in pre-bronchodilator FEV1 (volume) from baseline to Week 12.