A 24-week with possible extension, prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, phase III study to compare efficacy and safety of oral masitinib to placebo in treatment of patients with Smouldering or Indolent Severe Systemic mastocytosis with handicap, unresponsive to optimal symptomatic treatment

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514538-19-00

Acronym

AB15003

Enrollment

Registered

2025-01-30

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mastocytosis

Brief summary

The primary analysis (response on 3 handicaps) will be done on the ITT population. It is based on the cumulative response by patient handicap from week 8 to week 24

Detailed description

1.Handicaps, 2. Biological and Skin Parameters, 3. Quality of Life

Interventions

DRUGPlacebo to 100mg masitinib

DRUGPlacebo to 200mg masitinib

DRUGmasitinib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary analysis (response on 3 handicaps) will be done on the ITT population. It is based on the cumulative response by patient handicap from week 8 to week 24	—

Secondary

Measure	Time frame
1.Handicaps, 2. Biological and Skin Parameters, 3. Quality of Life	—

Countries

France, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026