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: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-000175-33-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-28
• Last Update Posted: 19 February 2018

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