Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis

NCT00831974 ↗

Phase 2 Completed 23 enrolled AB Science

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a 12 weeks study aimed at assessing the safety and efficacy of 2 doses of AB1010 in patients suffering from indolent systemic mastocytosis with handicap.

Timeline

Start: 2004-10
Primary completion: 2007-02
Completion: —

Outcome

Met primary endpoint

paper Improvement was observed in all primary endpoints at week 12 PMID 21108325 ↗

paper reduction of flushes, Hamilton rating, and pruritus as compared with baseline by 64% (P = 0.0005), 43% (P = 0.0049), and 36% (P = 0.0077), respectively. PMID 21108325 ↗

Publications

Results Paul C, Sans B, Suarez F, Casassus P, Barete S, Lanternier F, Grandpeix-Guyodo C, Dubreuil P, Palmerini F, Mansfield CD, Gineste P, Moussy A, Hermine O, Lortholary O. Masitinib for the treatment of systemic and cutaneous mastocytosis with handicap: a phase 2a study. Am J Hematol. 2010 Dec;85(12):921-5. doi: 10.1002/ajh.21894.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Masitinib	Small molecule	3 mg/kg	Oral
Subject	Masitinib	Small molecule	6 mg/kg	Oral