Masitinib for the Treatment of Severe Mast Cell Activation Syndrome

Part of paid clinical trials in Weldon Spring, Missouri.

Sponsor
AB Science
Study ID
NCT05449444
Phase
PHASE2
Status
Unknown

Conditions

  • Mast Cell Activation Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Masitinib 4.5 mg/kg/day — DRUG
    Masitinib 4.5 mg/kg/day
  • Placebo — DRUG
    Matching placebo
  • Best supportive care — OTHER
    Optimal concomitant symptomatic treatments. Includes: H1- and H2-antihistamines, sodium cromoglicate, antidepressants, antileukotrienes, proton pump inhibitors, and corticosteroids.
  • Masitinib 6.0 mg/kg/day — DRUG
    Masitinib 6.0 mg/kg/day

Study Details

To evaluate the efficacy and safety of two dosing schemes of oral masitinib versus matching placebo in the treatment of patients suffering from severe MCAS with handicap unresponsive to optimal symptomatic treatment.

Key Dates

Start date
Jul 1, 2022
Status verified
Feb 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Masitinib (4.5) & BSC
    Masitinib 4.5 mg/kg/day administered as an add-on to optimal concomitant symptomatic treatment (i.e. best supportive care, BSC). Participants receive masitinib (3.0 mg/kg/day) for 4 weeks, given orally twice daily, with a dose escalation to 4.5 mg/kg/day for the remainder of the treatment period. Each ascending dose titration is subjected to a safety control.
  • Experimental: Masitinib (6.0) & BSC
    Masitinib 6.0 mg/kg/day administered as an add-on to optimal concomitant symptomatic treatment (i.e. best supportive care, BSC). Participants receive masitinib (3.0 mg/kg/day) for 4 weeks, given orally twice daily, with a dose escalation to 4.5 mg/kg/day for4 weeks of treatment, then a second dose escalation to 6 mg/kg/day for the remainder of the treatment period. Each ascending dose titration is subjected to a safety control.
  • Placebo Comparator: Placebo & BSC
    Placebo administered as an add-on to optimal concomitant symptomatic treatment (i.e. best supportive care, BSC). Participants receive a matched dose placebo, given orally twice daily.

Primary Outcome Measure

Confirmed response at 50% [ Time Frame: 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St Charles Clinical ResearchWeldon SpringMissouri63304-

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St Charles Clinical Research· Weldon Spring, MO

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