A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis.

Phase 1

• Conditions: IDIOPATHIC PULMONARY FIBROSIS; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-001163-24-PL
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-01
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

- Adult patient, >/= 40 years of age
- Have a definite IPF diagnosis according to the 2011 ATS/ARS/ERS/ALAT consensus statement on IPF within the previous 5 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 Day 1, Visit 2 prior to randomization
- Diffusion capacity of the lung for carbon monoxide >/= 25% and - Ability to walk >/= 100 meters unassisted in 6 minutes.
- Cohort A (monotherapy): No background IPF therapy for >=4 weeks
allowed prior to randomization and throughout the placebo controlled
study period
- Cohort B (combination therapy): Tolerated dose of pirfenidone
<=2403 milligrams/once daily (mg/QD) for >=4 weeks required prior to
randomization and throughout the placebo controlled study 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 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 375

Exclusion Criteria

- 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
- An active upper or lower respiratory tract infection occurring at any
time within the screening period prior to the randomization visit
- Listeria monocytogenes infection or active parasitic infections within 6 months prior to Day 1, Visit 2
- 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.
Chronic treatment with pirfenidone within 4 weeks or five half lives
prior to screening (whichever is longer) to the end of the placebocontrolled
period (Day 365/Visit 16) (limited to Cohort A)
- For Cohort B: Known achalasia, esophageal stricture, or esophageal
dysfunction sufficient to limit the ability to swallow oral medication;
Tobacco smoking or use of tobacco-related products within 3 months of
screening or unwillingness to avoid smoking throughout the study; any
condition that, as assessed by the investigator, might be significantly
exacerbated by the known side effects associated with pirfenidone;
known or suspected peptic ulcer; use of strong CYP1A2 inhibitors (eg,
fluvoxamine or enoxacin) or moderate CYP1A2 inducers (limited to
tobacco smoking and tobacco related products) within 4 weeks of
randomization or during the study

Study & Design

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