A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01872689
• Date of registration: 05/06/2013
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
• Scientific title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis
• Date of first enrolment: October 13, 2013
• Target sample size: 505
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01872689
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Australia, Belgium, Canada, France, Germany, Italy, Japan, Mexico, Peru, Poland, Spain, United Kingdom, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Have a diagnosis of IPF within the previous 5 years from time of screening and
confirmed at baseline

- FVC >/=40 percent (%) and
- Stable baseline lung function as evidenced by a difference of less than (<) 10% in FVC
(in liters) measurements between screening and Day 1, Visit 2 prior to randomization

- DLco >/=25% and
- Ability to walk >/=100 meters unassisted in 6 minutes

- Cohort A: No background IPF therapy for >/=4 weeks allowed prior to randomization and
throughout the placebo-controlled study period

- Cohort B: Tolerated dose of pirfenidone >/=4 weeks required prior to randomization and throughout the placebo-controlled study
period

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

- 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
milliliters 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 infection 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 human immunodeficiency virus
infection

- Past use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including
lebrikizumab

- Evidence of acute or chronic hepatitis or known liver cirrhosis

Exclusions Criteria Limited to 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 period

- Known or suspected peptic ulcer

- Any condition that, as assessed by the investigator, might be significantly
exacerbated by the known side effects associated with pirfenidone

- Creatinine clearance <40 milliliters/minute, calculated using the Cockcroft-Gault
formula

- Use of following therapies within 4 weeks of randomization (Day 1, Visit 2) or during
the study: Strong inhibitors of CYP1A2 (Cytochrome P450 Family 1 Subfamily A Member 2)
(example: fluvoxamine or enoxacin); Moderate inducers of CYP1A2 (limited to tobacco
smoking and tobacco-related products)



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Placebo

Drug: Pirfenidone

Drug: Lebrikizumab

Primary Outcome(s)

Annualized Rate of Decrease in Percent Predicted Forced Vital Capacity (FVC) Over 52 Weeks [Time Frame: Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)]

Secondary Outcome(s)

Annualized Rate of Decrease in FVC Over 52 Weeks [Time Frame: Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)]

Minimum Observed Serum Concentration (Cmin) of Lebrikizumab [Time Frame: Predose (Hour 0) at Weeks 4, 12, 24, and 36]

Time to First Occurrence of a >/=10% Absolute Decline in Percent Predicted FVC or Death From Any Cause [Time Frame: Baseline up to the event of >/=10% absolute decline in percent predicted FVC or death from any cause, whichever occurred first (up to Week 122)]

Time to Respiratory-Related Hospitalization [Time Frame: Baseline up to the event of respiratory-related hospitalization (up to Week 122)]

Percentage of Participants With an Event of >/=15% Absolute Decrease in Percentage of Predicted DLco or Death From Any Cause [Time Frame: Baseline up to the event of >/=15% absolute decrease in percentage of predicted DLco or death from any cause (up to Week 122)]

Annualized Rate of Decline in 6-Minute Walk Test (6MWT) Distance Over 52 Weeks [Time Frame: Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)]

Percentage of Participants With Respiratory-Related Hospitalization [Time Frame: Baseline up to the event of respiratory-related hospitalization (up to Week 122)]

Percentage of Participants With Anti-therapeutic Antibody (ATA) to Lebrikizumab [Time Frame: Baseline and Post-Baseline (assessed at multiple time points: Weeks 4, 12, 24, 36, 52, 56, 64, 76, and at safety follow-up up to Week 122)]

Time to First Event of Acute IPF Exacerbation [Time Frame: Baseline up to the event of acute IPF exacerbation (up to Week 122)]

Percentage of Participants With an Event of St. George's Respiratory Questionnaire (SGRQ) Total Score Worsening or Death From Any Cause [Time Frame: Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122)]

Minimum Observed Serum Concentration (Cmin) of Lebrikizumab at Week 52 [Time Frame: Predose (Hour 0) at Week 52]

Percentage of Participants With an Event of Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation [Time Frame: Baseline up to the event of acute IPF exacerbation (up to Week 122)]

Progression-Free Survival (PFS) [Time Frame: Baseline up to the event of death from any cause, all cause hospitalization, or a decrease from baseline of >/=10% in FVC, whichever occurred first (up to Week 122)]

Annualized Rate of Decrease in Diffusion Capacity of the Lung for Carbon Monoxide (DLco) Over 52 Weeks [Time Frame: Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)]

Percentage of Participants With Event of Greater Than or Equal to (>/=) 10% Absolute Decline in Percent Predicted FVC or Death From Any Cause [Time Frame: Baseline up to the event of >/=10% absolute decline in percent predicted FVC or death from any cause, whichever occurred first (up to Week 122)]

Annualized Rate of Decrease in A Tool to Assess Quality of Life in IPF (ATAQ-IPF) Questionnaire Total Score Over 52 Weeks [Time Frame: Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)]

Time to First Event of >/=15% Absolute Decrease in Percentage of Predicted DLco or Death From Any Cause [Time Frame: Baseline up to the event of >/=15% absolute decrease in percentage of predicted DLco or death from any cause (up to Week 122)]

Elimination Half-Life (t1/2) of Lebrikizumab [Time Frame: Pre-dose (Hour 0) at Weeks 1, 4, 12, 24, 36, 64, 76, 88, 104; and at 4, 12, and 18 weeks post-last dose (last dose = Week 104)]

Percentage of Participants With Event of Death, All Cause Hospitalization, or a Decrease From Baseline of >/=10% in FVC [Time Frame: Baseline up to the event of death from any cause, all cause hospitalization, or a decrease from baseline of >/=10% in FVC, whichever occurred first (up to Week 122)]

Time to First Occurrence of SGRQ Total Score Worsening or Death From Any Cause [Time Frame: Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122)]

Secondary ID(s)

2013-001163-24

GB28547

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/08/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01872689