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
55
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Tacoma, Washington 98405
2013
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
493
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
642
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516 Lakeview Rd # 7
Clearwater, Florida 33756
830
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Clearwater, FL
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
992
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Miami, FL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
333
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326 North Mills Avenue
Orlando, Florida 32803
794
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Orlando, FL
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
619
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
971
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Weston, FL
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Albuquerque, New Mexico 87108
1330
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3820 Medical Park Dr
Austell, Georgia 30106
430
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Austell, GA
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
343
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5501 Hopkins Bayview Circle
Baltimore, Maryland 21224
347
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9459
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Camperdown,
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
524
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222 S Woods Mill Rd # 310N
Chesterfield, Missouri 63017
409
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5841 South Maryland Avenue
Chicago, Illinois 60637
270
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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98
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129
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Cleveland, OH
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790 College Parkway
Colchester, Vermont 05446
593
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Colchester, VT
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
2
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Decatur, Georgia 30033
433
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
1160
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3300 Gallows Road
Falls Church, Virginia 22042
318
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500 University Drive
Hershey, Pennsylvania 17033
335
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Hershey, PA
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1 Baylor Plaza
Houston, Texas 77030
995
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Houston, TX
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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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
1950
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394
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Madison, WI
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
283
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
330
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Minneapolis, Minnesota 55455
623
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
537
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480
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445 E 69th St
New York, New York 10021
(212) 746-1067
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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Oklahoma City, Oklahoma 73104
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Omaha, Nebraska 68198
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3401 North Broad Street
Philadelphia, Pennsylvania 19140
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Portland, ME
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Portland, Oregon 97210
2028
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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50 North Medical Drive
Salt Lake City, Utah 84108
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7400 Merton Minter
San Antonio, Texas 78229
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San Francisco, California 94143
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5777 E Mayo Blvd
Scottsdale, Arizona 85259
(480) 515-6296
Mayo Clinic Scottsdale Mayo Clinic Arizona was the second Mayo practice to be established outside...
1645
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1 Tampa General Circle
Tampa, Florida 33606
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1642
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Tucson, Arizona 85721
(520) 621-2211
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Wheat Ridge, Colorado 80033
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3311 East Murdock Street
Wichita, Kansas 67208
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