Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:3/15/2019
Start Date:December 22, 2017
End Date:November 2019
Contact:Lindsey Smith
Email:CFpatients@corbuspharma.com
Phone:617-977-5030

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing
the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12
years of age or older. Approximately 415 subjects will be enrolled in this study at about 100
sites in North America, Europe, and Australia. The planned duration of treatment with study
drug is 28 weeks.

Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.


Inclusion Criteria:

1. ≥ 12 years of age at the time Informed Consent/ Assent is signed.

2. Weight ≥ 40 kg.

3. FEV1 ≥ 40% predicted and < 100% predicted in the last 12 months.

4. Physician-initiated treatment with an IV antibiotic 2 or 3 times in the last 12 months
for a new PEx or physician-initiated treatment with an IV antibiotic 1 time in the
last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more
times in the past 12 months for a new PEX.

Exclusion Criteria:

1. Severe or unstable CF at screening or Visit 1.

2. Any of the following values for laboratory tests at screening:

1. A positive pregnancy test.

2. Hemoglobin < 10 g/dL in males and < 9 g/dL in females.

3. Neutrophils < 1.0 x 10^9 /L.

4. Platelets < 75 x 10^9/L.

5. Creatinine clearance < 50 mL/min according to Modification of Diet in Renal
Disease (MDRD) Study equation.

6. Serum transaminases > 2.5 x upper limit of normal.

3. Any medical condition or concurrent medical therapies at screening or Visit 1 that may
put the subject at greater safety risk, influence response to study drug or interfere
with study assessments.
We found this trial at
34
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Sioux Falls, South Dakota 57117
Principal Investigator: James Wallace, MD
Phone: 605-328-1372
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Natalie E West, MD, MHS
Phone: 443-287-8983
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Lael Yonker, MD
Phone: 617-726-3719
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Karen McCoy, MD
Phone: 614-722-4756
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Larry Johnson, MD
Phone: 501-686-5527
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Maria Gabriela Tupayachi Ortiz, MD
Phone: 305-243-5545
University of Miami A private research university with more than 15,000 students from around the...
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326 North Mills Avenue
Orlando, Florida 32803
Principal Investigator: Daniel Layish, MD
Phone: 407-841-1100
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Principal Investigator: Joseph M Pilewski, MD
Phone: 412-692-7044
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Michael Powers, MD
Phone: 503-418-8108
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Theodore Liou, MD
Phone: 801-587-8105
University of Utah Research is a major component in the life of the U benefiting...
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Atlanta, Georgia 30322
Principal Investigator: Arlene Stecenko, MD
Phone: 404-727-7398
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Henry Dorkin, MD
Phone: 617-355-6665
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Brussels,
Principal Investigator: Elke De Wachter
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Patrick A Flume, MD
Phone: 846-792-2072
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Manu Jain, MD
Phone: 312-695-0415
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Cleveland, Ohio 44106
Principal Investigator: James F Chmiel, MD
Phone: 216-286-0709
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Raksha Jain, MD
Phone: 214-648-2817
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
Principal Investigator: Steven Lommatzsch, MD
Phone: 303-398-1808
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Principal Investigator: Karen Schultz, MD
Phone: 682-885-6299
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Glenview, Illinois 60025
Principal Investigator: Steven Boas, MD
Phone: 847-998-3434
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Hawthorne, New York 10532
Principal Investigator: Allen Dozor, MD
Phone: 914-593-8800
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500 University Drive
Hershey, Pennsylvania 17033
Principal Investigator: Keith Randall Young, MD
Phone: 717-531-5646
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Lebanon, New Hampshire 03756
Principal Investigator: Alix Ashare, MD, PhD
Phone: 603-650-9718
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2801 Atlantic Ave
Long Beach, California 90806
(562) 933-5437
Principal Investigator: Cyrus Shahriary, MD
Phone: 562-933-5607
Miller Children's Hospital Miller Children
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Madison, Wisconsin 53792
Principal Investigator: Andrew Braun, MD
Phone: 608-263-1244
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Manchester, New Hampshire 03104
Principal Investigator: Alix Ashare, MD, PhD
Phone: 603-247-2821
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Morristown, New Jersey 07960
Principal Investigator: Arthur Atlas, MD
Phone: 973-971-4142
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New Brunswick, New Jersey 08903
Principal Investigator: Sabiha Hussain, MD
Phone: 732-235-5966
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New Hyde Park, New York 11040
Principal Investigator: Janice Wang, MD
Phone: 516-465-5412
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New York, New York 10003
Principal Investigator: Patricia Walker, MD
Phone: 212-420-4100
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Principal Investigator: Michael Stephen, MD
Phone: 215-762-5462
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Principal Investigator: Sophia Williams, MD
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Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Tampa, Florida 33606
Principal Investigator: Kapilkumar Patel, MD
Phone: 813-844-3543
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Tyler, Texas 75708
Principal Investigator: Rodolfo Amaro-Galvez, MD
Phone: 903-877-5435
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