Know Cancer

forgot password

The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients Prospective Double-blind, Placebo-controlled, Multicentre Study, XOLMA-Study

Phase 2/Phase 3
18 Years
70 Years
Open (Enrolling)

Thank you

Trial Information

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.

Inclusion Criteria

Inclusion criteria:

- Histological proven mastocytosis (cutaneous or systemic);

- Diagnosis made by one marrow unction and/or skin biopsy or other histological work

- Age: 18-70 years

Exclusion criteria

- Age <18 years;

- Known hypersensitivity to omalizumab or any of its components;

- History of cancer in previous 5 years;

- Patients with serious infections;

- Patients with active tuberculosis or undergoing anti-TB therapy;

- Patients currently treated with systemic immunosuppressive agents;

- Female patients who are pregnant or breast feeding;Contraception must be performed by
a save reliable and accept method such as oral or implanted contraceptives,
intravaginal or male preservatives or permanent methods such as tubal ligation.

- Patients with known positivity for human immunodeficiency virus (HIV). HIV screening
will be performed by an HIV 1/2 Antibody-detection test.

Note: Specific immunotherapy for insect sting allergy is no exclusion criteria.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Reduction of mast-cell induced adverse events and symptoms as summarized and calculated from patient's main complaint score and AFIRM score.

Outcome Time Frame:

10 months

Safety Issue:


Principal Investigator

01 Studienregister MasterAdmins

Investigator Role:

Study Director

Investigator Affiliation:

UniversitaetsSpital Zuerich


Switzerland: Swissmedic

Study ID:




Start Date:

September 2011

Completion Date:

October 2013

Related Keywords:

  • Mastocytosis
  • mastocytosis
  • omalizumab
  • Mastocytosis
  • Urticaria Pigmentosa
  • Mastocytoma