The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients Prospective Double-blind, Placebo-controlled, Multicentre Study, XOLMA-Study
The study will take place as double-blind placebo controlled study. After a first a
run-period of 2 months for all participants randomization (1:1) in two group will take
Group A: With omalizumab treatment for 6 months; dosage and administration schedule
according to body weight and total IgE level (1/2 of the patients). Group B: Placebo (1/2 of
the patients). After 4 months of treatment in both groups patients are encouraged to stop
all drugs given to reduce mast cell related effects, mainly antihistaminics . In case that
disturbing symptoms are reoccurring patients are allowed to restart these drugs. The
evaluation will take place after 5 months of treatment.
Finally, a follow up visit 1 and 4 months after the study will take place.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Reduction of mast-cell induced adverse events and symptoms as summarized and calculated from patient's main complaint score and AFIRM score.
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