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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01872689
First Posted: June 7, 2013
Last Update Posted: October 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab as monotherapy in the absence of background IPF therapy or as combination therapy with pirfenidone background therapy in participants with IPF. Participants will be randomized to receive either lebrikizumab or placebo subcutaneously (SC) every 4 weeks.

Condition Intervention Phase
Idiopathic Pulmonary Fibrosis Drug: Lebrikizumab Drug: Pirfenidone Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Annualized Rate of Decrease in Percent Predicted Forced Vital Capacity (FVC) Over 52 Weeks [ Time Frame: Baseline up to Week 52 ]

Secondary Outcome Measures:
  • Progression-Free Survival (PFS) Defined as Time From Randomization to Death, All Cause Hospitalization, or a Decrease From Baseline of Greater Than or Equal to (>=) 10 Percent (%) in FVC, Whichever Occurs First [ Time Frame: Baseline up to 18 weeks after last dose (last dose = Week 104) ]
  • Annualized Rate of Decrease in FVC (in Milliliters [mL] per Year) Over 52 Weeks [ Time Frame: Baseline up to Week 52 ]
  • Time to First Occurrence of a >= 10% Absolute Decline in Percent Predicted FVC or Death From Any Cause [ Time Frame: Baseline up to 18 weeks after last dose (last dose = Week 104) or death from any cause, whichever occurs first ]
  • Annualized Rate of Decrease in Diffusion Capacity of the Lung for Carbon Monoxide (DLco) Over 52 Weeks [ Time Frame: Baseline up to Week 52 ]
  • 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 ]
  • Time to Non-elective Hospitalization or Death From Any Cause [ Time Frame: Baseline up to 18 weeks after last dose (last dose = Week 104) or death from any cause, whichever occurs first ]
  • Annualized Rate of Decline in 6-Minute Walk Test (6MWT) Distance Over 52 Weeks [ Time Frame: Baseline up to Week 52 ]
  • Time to First Event of Acute IPF Exacerbation [ Time Frame: Baseline up to 18 weeks after last dose (last dose = Week 104) ]
  • Time to First Occurrence of St. George's Respiratory Questionnaire (SGRQ) Total Score Worsening (Defined as Total Score = 7 or Death From Any Cause) [ Time Frame: Baseline up to 18 weeks after last dose (last dose = Week 104) or death from any cause, whichever occurs first ]
  • Percentage of Participants with Adverse Events or Serious Adverse Events [ Time Frame: Baseline up to 18 weeks after last dose (last dose = Week 104) ]
  • Percentage of Participants with Anti-therapeutic Antibody (ATA) to Lebrikizumab [ Time Frame: Baseline up to 18 weeks after last dose (last dose = Week 104) ]
  • Serum Lebrikizumab Concentration at Week 52 (Cwk52) [ Time Frame: Pre-dose (at Hour 0) at Week 52 ]
  • Minimum Observed Serum Trough Lebrikizumab Concentration (Cmin) [ Time Frame: Pre-dose (at Hour 0) at Weeks 4, 12, 24, and 36 ]
  • Elimination Half-Life (t1/2) of Lebrikizumab [ Time Frame: Pre-dose (at Hour 0) at Weeks 1, 4, 12, 24, 36, 64, 76, 88, 104; at 4, 12, and 18 weeks post-last dose (last dose = Week 104) ]

Enrollment: 507
Actual Study Start Date: October 13, 2013
Estimated Study Completion Date: November 15, 2017
Primary Completion Date: July 28, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A: Monotherapy Lebrikizumab
Monotherapy of lebrikizumab 250 milligrams (mg) will be administered SC once every 4 weeks up to 52 weeks placebo-controlled treatment period, and thereafter for an additional 52 weeks (i.e., up to Week 104) in the open-label period.
Drug: Lebrikizumab
Administered SC every 4 weeks
Other Name: RO5490255
Placebo Comparator: Cohort A: Monotherapy Placebo
Placebo matched to lebrikizumab will be administered SC once every 4 weeks up to 52 weeks placebo-controlled treatment period. Thereafter, will be followed by lebrikizumab 250 mg administered SC every 4 weeks for additional for 52 weeks (i.e., up to Week 104) in the open-label period.
Drug: Lebrikizumab
Administered SC every 4 weeks
Other Name: RO5490255
Drug: Placebo
Administered SC every 4 weeks
Experimental: Cohort B: Combination Therapy (Lebrikizumab + Pirfenidone)
Pirfenidone less than or equal to (<=) 2403 mg once daily (maximum tolerated dose) will be administered in combination with lebrikizumab 250 mg SC once every 4 weeks up to 52 weeks placebo-controlled treatment period.
Drug: Lebrikizumab
Administered SC every 4 weeks
Other Name: RO5490255
Drug: Pirfenidone
Administered daily at the maximum tolerated dose
Placebo Comparator: Cohort B: Combination Therapy (Placebo + Pirfenidone)
Pirfenidone <= 2403 mg once daily (maximum tolerated dose) will be administered in combination with placebo matched to lebrikizumab SC once every 4 weeks up to 52 weeks placebo-controlled treatment period.
Drug: Pirfenidone
Administered daily at the maximum tolerated dose
Drug: Placebo
Administered SC every 4 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of IPF within the previous 5 years from time of screening and confirmed at baseline
  • FVC >=40 % and <= 100% predicted at screening
  • Stable baseline lung function as evidenced by a difference of less than (<) 10% in FVC (liters) measurements between screening and Day 1, Visit 2 prior to randomization
  • DLco >=25% and <=90% predicted at screening
  • 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 <=2403 milligrams once daily (mg/QD) for >=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 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 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 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 mL/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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872689


  Show 112 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01872689     History of Changes
Other Study ID Numbers: GB28547
2013-001163-24 ( EudraCT Number )
First Submitted: June 5, 2013
First Posted: June 7, 2013
Last Update Posted: October 24, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Pirfenidone
Antibodies, Monoclonal
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Immunologic Factors