A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER TRIAL TO ASSESS THE ORAL CORTICOSTEROID*SPARING EFFECT OF LEBRIKIZUMAB IN PATIENTS WITH SEVERE CORTICOSTEROID-DEPENDENT ASTHMA.
- Conditions
- AsthmaSevere corticosteroid dependent Asthma10046304
- Registration Number
- NL-OMON42207
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
- Patients, age 18-75 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 dependence on minimal effective or maximum tolerated dose prior to visit 1 with compliance
- 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
- 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy Outcome Measures<br /><br>The primary efficacy outcome measure for this study is the following:<br /><br>* Relative change in daily OCS dose from baseline to Week 44</p><br>
- Secondary Outcome Measures
Name Time Method