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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT03265288

Run by

Laurent Pharmaceuticals Inc.

People needed

166

Starts

2018-11-05

Expected to finish

2021-09-15

Last updated by the study team

2024-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 or Oral 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), Symdeko® (ivacaftor/tezacaftor) or other commercially available CFTR modulator products, patients must be taking it for a minimum of 3 months prior to screening if naïve to CFTR modulators and 1 month if switched from another CFTR modulator product and deemed to tolerate it;
• No change in CF and allowed systemic chronic therapy for a minimum of 5 weeks prior to randomization, of which 2 weeks minimum are 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.

You may not qualify if…

• 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 5 weeks prior to randomization, of which 2 weeks minimum are 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.

Where it is running

• Long Beach Memorial Medical Center — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• UC Davis Medical Center, Division of Pulmonary & Critical Care Medicine — Sacramento, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Division of pulmonary, critical care and sleep medicine, University of Florida — Gainesville, Florida, United States
• Memorial Healthcare System, Joe DiMaggio Children's Hospital Cystic Fibrosis & Pulmonary Center — Hollywood, Florida, United States
• Avanza Medical Research Center — Pensacola, Florida, United States
• St-Luke's CF Center of Idaho — Boise, Idaho, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Maine Medical Center Cystic Fibrosis Research — Portland, Maine, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Wayne State University, Harper University Hospital — Detroit, Michigan, United States
• The Minnesota Cystic Fibrosis Center, University of Minnesota — Minneapolis, Minnesota, United States
• Washington University Medical School — St Louis, Missouri, United States
• Morristown Medical Center, NJ Adult Cystic Fibrosis Center — Morristown, New Jersey, United States
• Rutgers University Clinical Research Center, RW Johnson University Hospital — New Brunswick, New Jersey, United States
• Albany Medical College — Albany, New York, United States
• University Hospitals Cleveland Medical Center, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Cystic Fibrosis Center, Doernbecher Children's Hospital, Oregon Health & Science University — Portland, Oregon, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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