Study: NCT04129931

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MCT
Description: Mix 1-2 packets, as instructed by a physician, into liquid or food three times daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Clazakizumab
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Broncho-Vaxom
Description: 7 mg taken orally once a day, on an empty stomach, for 16 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Imatinib Mesylate
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cavosonstat
Description: 50 mg capsule orally twice a day for 16 weeks.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 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.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 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.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 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.