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



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:8/26/2018
Start Date:October 13, 2013
End Date:November 6, 2017

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A Phase II, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis

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 and as combination therapy with pirfenidone background therapy in participants
with IPF. Participants will be randomized to receive either lebrikizumab or placebo
subcutaneously every 4 weeks.


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)
We found this trial at
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50 North Medical Drive
Salt Lake City, Utah 84108
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1720 2nd Ave S
Birmingham, Alabama 35233
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800 Washington St
Boston, Massachusetts 02111
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516 Lakeview Rd # 7
Clearwater, Florida 33756
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Miami, Florida 33124
(305) 284-2211
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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326 North Mills Avenue
Orlando, Florida 32803
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
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Albuquerque, New Mexico 87108
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3820 Medical Park Dr
Austell, Georgia 30106
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
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5501 Hopkins Bayview Circle
Baltimore, Maryland 21224
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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222 S Woods Mill Rd # 310N
Chesterfield, Missouri 63017
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5841 South Maryland Avenue
Chicago, Illinois 60637
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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790 College Parkway
Colchester, Vermont 05446
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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Decatur, Georgia 30033
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
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3300 Gallows Road
Falls Church, Virginia 22042
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500 University Drive
Hershey, Pennsylvania 17033
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1 Baylor Plaza
Houston, Texas 77030
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
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200 Hawkins Drive
Iowa City, Iowa 52242
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Jacksonville, Florida 32216
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3901 Rainbow Boulevard
Kansas, Kansas 66160
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La Jolla, California 92093
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
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8701 W Watertown Plank Rd
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(414) 955-8296
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Minneapolis, Minnesota 55455
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
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445 E 69th St
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200 First Street SW
Rochester, Minnesota 55905
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Tacoma, Washington 98405
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1 Tampa General Circle
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Tucson, Arizona 85721
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Wheat Ridge, Colorado 80033
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3311 East Murdock Street
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