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

Use our guide to learn which trials are right for you!

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
sites
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...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
?
mi
from
Boston, MA
Click here to add this to my saved trials
516 Lakeview Rd # 7
Clearwater, Florida 33756
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
?
mi
from
Miami, FL
Click here to add this to my saved trials
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...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
326 North Mills Avenue
Orlando, Florida 32803
?
mi
from
Orlando, FL
Click here to add this to my saved trials
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,...
?
mi
from
Providence, RI
Click here to add this to my saved trials
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...
?
mi
from
Weston, FL
Click here to add this to my saved trials
Albuquerque, New Mexico 87108
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
3820 Medical Park Dr
Austell, Georgia 30106
?
mi
from
Austell, GA
Click here to add this to my saved trials
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...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
5501 Hopkins Bayview Circle
Baltimore, Maryland 21224
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Camperdown,
Click here to add this to my saved trials
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...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
222 S Woods Mill Rd # 310N
Chesterfield, Missouri 63017
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
5841 South Maryland Avenue
Chicago, Illinois 60637
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
790 College Parkway
Colchester, Vermont 05446
?
mi
from
Colchester, VT
Click here to add this to my saved trials
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...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Decatur, Georgia 30033
?
mi
from
Decatur, GA
Click here to add this to my saved trials
1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
?
mi
from
Denver, CO
Click here to add this to my saved trials
3300 Gallows Road
Falls Church, Virginia 22042
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
500 University Drive
Hershey, Pennsylvania 17033
?
mi
from
Hershey, PA
Click here to add this to my saved trials
1 Baylor Plaza
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
?
mi
from
Houston, TX
Click here to add this to my saved trials
200 Hawkins Drive
Iowa City, Iowa 52242
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
3901 Rainbow Boulevard
Kansas, Kansas 66160
?
mi
from
Kansas, KS
Click here to add this to my saved trials
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
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...
?
mi
from
Maywood, IL
Click here to add this to my saved trials
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...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
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...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Omaha, Nebraska 68198
?
mi
from
Omaha, NE
Click here to add this to my saved trials
3401 North Broad Street
Philadelphia, Pennsylvania 19140
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Portland, ME
Click here to add this to my saved trials
Portland, Oregon 97210
?
mi
from
Portland, OR
Click here to add this to my saved trials
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...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
?
mi
from
Rochester, NY
Click here to add this to my saved trials
50 North Medical Drive
Salt Lake City, Utah 84108
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
7400 Merton Minter
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
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...
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Tacoma, Washington 98405
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
1 Tampa General Circle
Tampa, Florida 33606
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Wheat Ridge, Colorado 80033
?
mi
from
Wheat Ridge, CO
Click here to add this to my saved trials
3311 East Murdock Street
Wichita, Kansas 67208
?
mi
from
Wichita, KS
Click here to add this to my saved trials