395
Participants
Start Date
December 19, 2019
Primary Completion Date
February 19, 2025
Study Completion Date
March 19, 2025
MCT
Mix 1-2 packets, as instructed by a physician, into liquid or food three times daily
Clazakizumab
12.5 mg subcutaneous injection given once every 4 weeks for 16 weeks. Lab driven dose reductions will be made based on safety lab data. If criteria are met for dose reduction, the participant will be reduced to a 6.25 mg dose.
Broncho-Vaxom
7 mg taken orally once a day, on an empty stomach, for 16 weeks
Imatinib Mesylate
Two 100 mg tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. If the drug is well tolerated, participants will titrate up to four 100 mg tablets once a day with a meal and an 8 oz glass of water for 14 weeks. Safety labs will be collected at each study visit to monitor the tolerability of each participant.
Cavosonstat
50 mg capsule orally twice a day for 16 weeks.
Placebo
"MCT Matching Placebo: MCT matching placebo packets. Mix 1-2 packets, as instructed by a physician, into liquid or food three times daily~Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks for 16 weeks.~Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks~Imatinib Matching Placebo: Two 100 mg placebo tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. Then four 100 mg placebo tablets once a day with a meal and an 8 oz glass of water for 14 weeks.~Cavosonstat Matching Placebo: 50 mg matching placebo capsule orally twice a day for 16 weeks."
Mount Sinai, New York
Columbia University Medical Center, New York
Wake Forest University, Winston-Salem
University of South Florida, Tampa
Vanderbilt University, Nashville
Cleveland Clinic, Cleveland
University Hospitals Rainbow Babies & Children's Hospital, Cleveland
Riley Hospital for Children, Indianapolis
University of Michigan, Ann Arbor
University of Wisconsin-Madison, Madison
University of Illinois at Chicago, Chicago
Ann & Robert H. Lurie Children's Hospital, Chicago
Northwestern Universtiy, Chicago
Rush University, Chicago
University of Chicago, Chicago
Washington University, St Louis
University of Kansas, Kansas City
Children's Hospital Colorado, Aurora
University of Colorado Denver, Aurora
Mayo Clinic Scottsdale, Scottsdale
University of Arizona Tucson, Tucson
University of California San Diego: Airway Research & Clinical Trials Center, San Diego
University of California San Diego: La Jolla Altman Clinical Translation Research Institute, San Diego
University of California San Francisco, San Francisco
University of California Davis, Sacramento
National Jewish Health, Denver
Yale University, New Haven
Boston Children's Hospital, Boston
Brigham and Women's Hospital, Boston
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of North Carolina, Chapel Hill
OTHER