Study of LAU-7b in the Treatment of Cystic Fibrosis in Adults



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:2/10/2019
Start Date:October 10, 2018
End Date:December 2019
Contact:Jean-Marie Houle, PhD
Email:jmhoule@laurentpharma.com
Phone:514-941-2313

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APPLAUD: A Double-Blind, Randomized, Placebo-Controlled, Phase II Study of the Efficacy and Safety of LAU-7b in the Treatment of Cystic Fibrosis in Adults

An International Phase II, double-blind, randomized, placebo-controlled study to evaluate the
safety and efficacy of LAU-7b administered once-daily for 6 months for the treatment of CF.

An International Phase II, double-blind, randomized, placebo-controlled study to evaluate the
safety and efficacy of LAU-7b administered once-daily for 6 months for the treatment of CF.
All patients will remain on their CF standard-of-care treatments over the trial duration.

The goal for the treatment with LAU-7b in CF is to preserve lung function by reducing the
persistent inflammation in the lung and to improve its capacity to defend against resistant
bacteria such as Pseudomonas aeruginosa.

The treatment regimen will consist of 6 consecutive "dosing cycles" of 21 days each, spaced
by study drug-free periods of 7 days. A total of 136 eligible adult patients with CF will be
randomized to receive 300 mg LAU-7b or placebo in a 1:1 ratio. The participation in the study
will last about 7 months.

Inclusion Criteria:

- Screening FEV1 between 40% and 100% predicted value for age, gender and height, in
patients capable of properly performing the test;

- History of pulmonary exacerbation, defined as at least one (1) pulmonary exacerbation
in the year prior to Screening which resulted in documented intravenous antibiotics;

- Patients are eligible independently of their history of pulmonary Pseudomonas
aeruginosa (PsA) infection and their PsA status at screening;

- If taking Kalydeco® (ivacaftor), Orkambi® (ivacaftor/lumacaftor) or Symdeko®
(ivacaftor/tezacaftor), patients must be taking it for a minimum of 3 months prior to
screening, and deemed to tolerate it;

- No change in CF and allowed systemic chronic therapy for a minimum of 1 month prior to
screening;

- Female patients of child bearing potential should be on highly effective contraceptive
methods during the study;

- Male patients with spouse or partner of child bearing potential, or pregnant, are
eligible if they use an appropriate method of contraception.

Exclusion Criteria:

- Pregnancy: due to the potential teratogenic effects of retinoids, pregnant women are
NOT eligible;

- Breast milk feeding by study patient is NOT allowed;

- Clinically abnormal renal function: serum creatinine > 132 μM (1.5 mg/dL);

- Clinically abnormal liver function: Total bilirubin >1.5 x ULN (in the absence of
demonstrated Gilbert's syndrome), alanine aminotransferase (ALT) and/or aspartate
aminotransferase (AST) > 2.5 x ULN;

- Patients with plasma retinol levels below 0.7 µM;

- Presence of nyctalopia or hemeralopia at enrolment, or any other serious retinal,
ophthalmological condition;

- Presence of serious dermatological conditions at entry, including inflammatory or
xerotic skin pathologies such as psoriasis or ichthyosis;

- Intake of chronic systemic steroids in the month prior to screening and during the
study;

- History of acute infections (viral/bacterial/fungal) within 1 month prior to
screening, whether or not treated and resolved;

- Presence of infection with Burkholderia cepacia (including all species within the
Burkholderia cepacia complex group, and Burkholderia gladioli) in the 12 months prior
to screening;

- Patients with a confirmed diagnosis (as per the Cystic Fibrosis Foundation diagnostic
criteria) of Allergic BronchoPulmonary Aspergillosis (ABPA) and actively being treated
with corticosteroids and/or anti fungal agents.
We found this trial at
21
sites
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Theodore G 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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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Karen S McCoy, MD
Phone: 614-722-4766
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Principal Investigator: Joseph M Pilewski, MD
Phone: 412-692-8069
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Principal Investigator: Thomas C Smith, MD
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Albany, NY
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Samya Nasr, MD
University of Michigan Health System The University of Michigan is home to one of the...
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Boise, Idaho 83712
Principal Investigator: Karen Miller, MD
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11100 Euclid Avenue
Cleveland, Ohio 44106
Principal Investigator: Erica A Roesch, MD
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Detroit, Michigan 48201
Principal Investigator: Dana Kissner, MD
Phone: 313-745-9537
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Detroit, MI
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Gainesville, Florida 32610
Principal Investigator: Cesar Trillo-Alvarez, MD
Phone: 352-294-5195
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Hollywood, Florida 33021
Principal Investigator: Lance Cohen, MD
Phone: 954-265-3076
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Deepika Polineni, MD MPH
Phone: 913-588-4020
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Milwaukee, Wisconsin 53226
Principal Investigator: Rose Franco, MD
Phone: 414-955-7019
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Milwaukee, WI
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Minneapolis, Minnesota 55455
Principal Investigator: Joanne Billings, MD
Phone: 612-626-2743
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Morristown, New Jersey 07962
Principal Investigator: Rebecca A Griffith, MD
Phone: 973-971-7293
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New Brunswick, New Jersey 08901
Principal Investigator: Sabiha Hussain, MD
Phone: 732-235-5965
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Nighat F Mehdi, MD FAAP
Phone: 405-271-8001
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Ottawa, Ontario
Principal Investigator: Shawn Aaron, MD
Phone: 613-737-8899
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Portland, Oregon 97239
Principal Investigator: Kelvin D MacDonald, MD
Phone: 503-494-7807
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Nauman Chaudary, MD
Phone: 804-628-3921
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Sacramento, California 95817
Principal Investigator: Brian Morrissey, MD
Phone: 916-734-8686
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Saint Louis, Missouri 63110
Principal Investigator: Jeffrey J Atkinson, MD
Phone: 314-454-5175
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