A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS.
- Conditions
- IDIOPATHIC PULMONARY FIBROSISTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2013-001163-24-IT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 505
- Adult patient, >/= 40 years of age
- Have a definite IPF diagnosis according to the 2011 ATS/ARS/JRS/ALAT consensus statement on IPF within the previous 4 years from time of screening and confirmed at baseline
- Forced vital capacity (FVC) >/= 40% and - Stable baseline lung function as evidenced by a difference of < 10% in FVC (L) measurements between screening and randomization
- Diffusion capacity of the lung for carbon monoxide >/= 25% and - Ability to walk >/= 100 meters unassisted in 6 minutes.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
- History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
- Evidence of other known causes of interstitial lung disease (ILD)
- Lung transplant expected within 12 months of screening
- Evidence of clinically significant lung disease other than IPF
- Post bronchodilator forced expiratory volume in 1 second (FEV1)/FVC ratio < 0.7 at screening
- Positive bronchodilator response, evidenced by an increase of >/= 12% predicted and 200 mL increase in FEV1 or FVC
- Class IV New York Heart Association chronic heart failure or historical evidence of left ventricular ejection fraction < 35%
- Hospitalization due to an exacerbation of IPF within 4 weeks prior to or during screening
- Known current malignancy or current evaluation for potential malignancy
- Listeria monocytogenes infection or active parasitic infections within 6 months prior to randomization.
- Active tuberculosis requiring treatment within 12 months of screening
- Known immunodeficiency, including but not limited to HIV infection
- Past use of any anti-IL-13 or anti-IL-14/IL-13 therapy, including lebrikizumab
- Evidence of acute or chronic hepatitis or known liver cirrhosis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To evaluate safety of lebrikizumab compared with placebo in patients with IPF<br>• To evaluate efficacy of lebrikizumab compared with placebo in patients with IPF, as measured by progression-free survival (PFS).;Secondary Objective: • To evaluate the efficacy of lebrikizumab compared with placebo in patients with IPF on the basis of pulmonary function, diffusion capacity, death, non-elective hospitalization from any cause, and acute IPF exacerbations <br>• To evaluate the efficacy of lebrikizumab compared with placebo in patients with IPF on the basis of distance walked in 6 minutes and patient reported health-related quality of life.<br>;Primary end point(s): Progression-free survival;Timepoint(s) of evaluation of this end point: up to 2.5 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change in pulmonary function (FVC, [L])<br>2. Change in diffusion capacity of the lung for carbon monoxide<br>3. Change in Quality of Life measurements<br>4. Time from randomization to death or non-elective hospitalization from any cause<br>5. Change in six minute walk test<br>6. Time from randomization to first event of acute IPF exacerbation<br>7. Safety: Incidence of adverse events;Timepoint(s) of evaluation of this end point: 1. up to 2.5 years<br>2. from baseline to end of treatment (up to 2.5 years)<br>3. from baseline to Week 52<br>4. up to 2.5 years<br>5. from baseline to Week 52<br>6. up to 2.5 years<br>7. up to 2.5 years