PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study

PHASE2CompletedINTERVENTIONAL
Enrollment

395

Participants

Timeline

Start Date

December 19, 2019

Primary Completion Date

February 19, 2025

Study Completion Date

March 19, 2025

Conditions
Asthma
Interventions
DRUG

MCT

Mix 1-2 packets, as instructed by a physician, into liquid or food three times daily

DRUG

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.

DRUG

Broncho-Vaxom

7 mg taken orally once a day, on an empty stomach, for 16 weeks

DRUG

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.

DRUG

Cavosonstat

50 mg capsule orally twice a day for 16 weeks.

OTHER

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."

Trial Locations (29)

10029

Mount Sinai, New York

10031

Columbia University Medical Center, New York

27104

Wake Forest University, Winston-Salem

33613

University of South Florida, Tampa

37232

Vanderbilt University, Nashville

44106

Cleveland Clinic, Cleveland

University Hospitals Rainbow Babies & Children's Hospital, Cleveland

46202

Riley Hospital for Children, Indianapolis

48109

University of Michigan, Ann Arbor

53792

University of Wisconsin-Madison, Madison

60608

University of Illinois at Chicago, Chicago

60611

Ann & Robert H. Lurie Children's Hospital, Chicago

Northwestern Universtiy, Chicago

60612

Rush University, Chicago

60637

University of Chicago, Chicago

63110

Washington University, St Louis

66160

University of Kansas, Kansas City

80045

Children's Hospital Colorado, Aurora

University of Colorado Denver, Aurora

85259

Mayo Clinic Scottsdale, Scottsdale

85724

University of Arizona Tucson, Tucson

92103

University of California San Diego: Airway Research & Clinical Trials Center, San Diego

92121

University of California San Diego: La Jolla Altman Clinical Translation Research Institute, San Diego

94143

University of California San Francisco, San Francisco

95817

University of California Davis, Sacramento

802006

National Jewish Health, Denver

06520

Yale University, New Haven

02115

Boston Children's Hospital, Boston

Brigham and Women's Hospital, Boston

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

University of North Carolina, Chapel Hill

OTHER

NCT04129931 - PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study | Biotech Hunter | Biotech Hunter