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

Conditions

• Asthma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• MCT — DRUG
  Mix 2-5 packets daily into liquid or food for 16 weeks.
• Clazakizumab — DRUG
  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 — DRUG
  7 mg taken orally once a day, on an empty stomach, for 16 weeks
• Imatinib Mesylate — DRUG
  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 — DRUG
  50 mg capsule orally twice a day for 16 weeks.
• Placebo — OTHER
  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.

Study Details

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.

Key Dates

Start date

Dec 19, 2019

Status verified

Feb 2026

Primary completion

Feb 19, 2025

Completion

Mar 19, 2025

Study Design

Enrollment

950 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Medium Chain Triglycerides (MCT)
  Participants in this arm will receive Medium Chain Triglycerides (MCT) powder packets (12.5 g each) daily for the 16 week treatment period. Participants are assigned one packet per 500 kilocalories required to maintain bodyweight; the target dose for each participant is between 2 and 5 packets daily. Participants will mix the packets of MCT supplement powder into liquids or semi-solid food. Participants will be randomized to the treatment sequence and will receive either the active MCT or the matching placebo first or vice versa.
• Experimental: Clazakizumab
  Participants randomized to this arm will receive a 12.5 mg dose of Clazakizumab via a subcutaneous injection at every study visit, every 4 weeks, during the 16-week treatment period at any point in the study. Participants will be randomized to the treatment sequence and will receive either the active Clazakizumab or the matching placebo first or vice versa.
• Experimental: Broncho-Vaxom
  Participants randomized to this arm will receive 7 mg of Broncho-Vaxom once a day on an empty stomach for the 16-week treatment period duration at any point in the study. Participants will be randomized to the treatment sequence and will receive either the active Broncho-Vaxom or the matching placebo first or vice versa.
• Experimental: Imatinib
  Participants randomized to this arm will take two 100 mg Imatinib tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. Participants will then take four 100 mg tablets once a day with a meal and an 8 oz glass of water for 14 weeks. Participants will be randomized to the treatment sequence and will receive either the active Imatinib or the matching placebo first or vice versa.
• Experimental: Cavosonstat
  Participants randomized to this arm will take one 50 mg Cavosonstat capsule orally twice a day for the 16-week treatment period duration at any point in the study. Participants will be randomized to the treatment sequence and will receive either the active Cavosonstat or the matching placebo first or vice versa.

Primary Outcome Measure

Forced Expiratory Volume in One Second (FEV1) Percent Predicted [ Time Frame: Measured at 16 weeks after the start of treatment. ]

Locations (29)

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