Cystic Fibrosis Treatment with Lenabasum – Phase II

Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

Protocol Description

This multi-center study investigates the safety and therapeutic benefit of lenabasum in people with cystic fibrosis, a rare progressive genetic disease. This condition is caused by a defect in the CFTR gene, which causes the body to produce mucus that is thicker than normal. In persons with cystic fibrosis, thicker mucus has trouble moving through the body, causing chronic inflammation and repeated infections in the lungs. Researchers believe lenabasum may have the ability to stop chronic inflammation and pulmonary exacerbation events.

Study Level: Phase II

Eligibility Criteria

This study is open to participants of both genders, ages 12 and up, who have cystic fibrosis.
Males and females: Ages 12 years and older

Requirements

In this study, participants will either receive the investigational drug at one of two dose levels or a placebo to be taken orally in capsule form twice a day for a period of 28 weeks.
Visits: 11
Duration: 32 weeks

Status: Open to Enrollment

Source(s) of Support

Corbus Pharmaceuticals

Primary Investigator

Joseph Pilewski, MD

Contact Information

For more information about the study or enrollment, please contact:
Clinical Research Nurse Coordinator
Carley McDowell, RN, BS, MSN
412-692-7044