NCT04129931

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 950 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate several interventions given to participants with severe asthma. Interventions are administered in a crossover manner with 16-week treatment periods followed by 8 to 16 week washout.

Detailed description

PrecISE is a clinical study sponsored by the U.S. National Heart, Lung, and Blood Institute (NHLBI) to investigate several treatments for severe asthma. PrecISE will enroll 600 adults and teenagers (ages 12 years and older) with severe asthma who have symptoms that are not well-controlled on high dose of inhaled corticosteroids including those who have frequent asthma attacks. Each person who agrees to enroll in the PrecISE study will receive several treatments for research purposes based on their type of severe asthma. The goal of PrecISE is to understand how to treat different types of severe asthma, by using precision medicine. Precision medicine is an approach that targets treatments to defined subgroups of patients who share similar characteristics, for example, patients with a certain genetic variation or patients with high number of blood eosinophils. Researchers from over 30 locations across the US are involved in PrecISE.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	MCT	Mix 2-5 packets daily into liquid or food for 16 weeks.
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 2-5 packets daily into liquid or food for 16 weeks. 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.

Timeline

• Start date: 2019-12-19
• Primary completion: 2025-02-19
• Completion: 2025-03-19
• First posted: 2019-10-17
• Last updated: 2026-04-01
• Results posted: 2026-04-01

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated drug study