A 24-WEEK WITH POSSIBLE EXTENSION, PROSPECTIVE, MULTICENTRE, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, 2-PARALLEL GROUP WITH A RANDOMIZATION 1:1, PHASE 3 STUDY TO COMPARE EFFICACY AND SAFETY OF MASITINIB AT 6 MG/KG/DAY TO PLACEBO IN TREATMENT OF PATIENTS WITH SMOULDERING SYSTEMIC, INDOLENT SYSTEMIC OR CUTANEOUS MASTOCYTOSIS WITH HANDICAP

Registry ID

AB06006

Source registry

HEALTH_CANADA

Status

Pending

Phase

PHASE3

Study type

INTERVENTIONAL

Sponsor

AB SCIENCE S.A.

Last update

2014-04-28

Conditions

• SMOLDERING SYSTEMIC MASTOCYTOSIS
• INDOLENT SYSTEMIC MASTOCYTOSIS
• CUTANEOUS MASTOCYTOSIS WITH HANDICAP

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• A 3-PART, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY TO EVALUATE SAFETY AND EFFICACY OF AVAPRITINIB (BLU-285), A SELECTIVE KIT MUTATION-TARGETED TYROSINE KINASE INHIBITOR, IN INDOLENT AND SMOLDERING SYSTEMIC MASTOCYTOSIS WITH SYMPTOMS INADEQUATELY CONTROLLED WITH STANDARD THERAPY

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