A STUDY OF LEBRIKIZUMAB IN PATIENTS WITH SEVERE ASTHMA WHO DEPEND ON ORAL CORTICOSTEROIDS.
- Conditions
- MedDRA version: 19.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Asthma
- Registration Number
- EUCTR2012-000190-24-CZ
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 225
- Patients, age 12-75 years at the time of informed consent
- Severe asthma despite intensive follow-up by an asthma specialist for at least 6 months prior to Visit 1
- Baseline forced expiratory volume in 1 second (FEV1) >=40% of predicted prior to randomization
-Receiving high doses of inhaled glucocorticosteroids at a total daily dose of >= 1500 mcg beclomethasone dipropionate daily or equivalent and long-acting beta-adrenoceptor agonist (LABA), with or without an additional controller, for at least 3 months prior to Visit 1
- Chronic treatment with maintenance oral corticosteroids (prednisone/prednisolone) for at least 6 months prior to Visit 1
- Assessment to ensure diagnosis of refractory asthma and oral corticosteroid (prednisone/prednisolone) dependence on minimal effective or maximum tolerated dose prior to Visit 1 with compliance
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
- History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
- Asthma exacerbation within 28 days prior to Visit 1 or during screening (prior to Visit 3)
- For adults: Active tuberculosis requiring treatment within the 12 months prior to visit 1
- For adolescents: History of active tuberculosis requiring treatment
- Evidence of acute or chronic hepatitis or known liver cirrhosis
- Known current malignancy or current evaluation for a potential malignancy
- History of interstitial lung disease, chronic obstructive pulmonary disease, or other clinically significant lung disease other than asthma
- 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
- Current smoker or former smoker with a smoking history of >15 pack-years
- Current use of an immunomodulatory/immunosuppressive therapy or past use within 3 months or 5 drug half-lives (whichever is longer) prior to visit 1
- Use of a licensed or investigational monoclonal antibody other than anti IL-13 or anti IL-4/IL-13, including, but not limited to, omalizumab, anti IL-5, or anti IL-17, within 6 months or 5 drug half-lives (whichever is longer) prior to visit 1
- Receipt of a live, attenuated vaccine within the 4 weeks prior to visit 1, during screening or anticipation of receipt of alive, attenuated vaccine throughout the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: • To assess the efficacy of lebrikizumab compared with placebo as measured by asthma exacerbation rate, lung function, fraction of exhaled nitric oxide (FeNO).;Main Objective: • To evaluate the efficacy of lebrikizumab compared with placebo as measured by the ability of patients to achieve lower daily doses of oral corticosteroids (OCS; prednisone/prednisolone) while maintaining control of their asthma <br>• To evaluate periostin as a predictive biomarker to select patients most likely to receive benefit from lebrikizumab therapy <br>• To evaluate the safety and tolerability of lebrikizumab compared with placebo.;Primary end point(s): Relative change in daily oral corticosteroids dose ;Timepoint(s) of evaluation of this end point: From Baseline to week 44
- Secondary Outcome Measures
Name Time Method