The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients

NCT01333293 | Completed Phase 2

• 1 other identifier: CIGE025ACH03T V1
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

Patients with mastocytosis often suffer from associated symptoms such as nausea, vertigo, fatigue, urticaria, abdominal cramps, diarrhea or hypotension due to release of mediators by mast cells. These patients have also an increased frequency of anaphylactic/anaphylactoid reactions due to allergens such as hymenoptera or nonspecific stimuli such as contrast media, local anesthetics or analgesics. In addition, there is increased osteoporosis in mastocytosis patients due to the activity of mast cell mediators on osteoblasts and osteoclasts. Symptoms of mastocytosis respond poorly to treatment with antihistamines or other antiallergic drugs. There is currently no specific treatment for this disease with the exception of rare cases. There are, however, some case reports suggesting that omalizumab might decrease symptoms including hypotensive events. The aim of the study is to investigate whether patients suffering from mastocytosis benefit from a 6 month course of omalizumab with regard to symptoms and quality of life and whether the applied in vitro and in vivo monitoring tools represent useful surrogate markers for the efficacy of omalizumab in patients with mastocytosis.

• Trial with medicinal product

Conditions

Mastocytosis

Keywords

mastocytosis; omalizumab

Outcome Measures

Primary Outcomes (1)

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

  10 months

Secondary Outcomes (3)

• Effect on the consumption or possibility to reduce mast-cell related drugs

  10 months

• Effect on: - Lung function (FEV1), analysed by standard lung function measurements - blood pressure, - quantitative measurement of pressure-induced wheal and flare.

  10 months

• Effect on in-vitro parameters (Tryptase levels, density of Fc-IgE-R expression on basophils, Platelet-Activation-Factor (PAF) and cysteinyl leukotriene LTC4)

  10 months

Study Arms (2)

Omalizumab

EXPERIMENTAL

Drug: injections

Placebo

PLACEBO COMPARATOR

Drug: injections

Interventions

injections DRUG

subcutaneous injections

Omalizumab; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological proven mastocytosis (cutaneous or systemic);
• Diagnosis made by one marrow unction and/or skin biopsy or other histological work up;
• Age: 18-70 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (3)

University Hospital Berne (Insel) and Zieglerspital Berne

Bern, Switzerland

Location

Geneva University Hospitals and Medical Faculty of the University of Geneva

Geneva, Switzerland

Location

Allergy Unit, Department of Dermatology, University Hospital Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Mastocytosis

Interventions

Injections

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Mast Cell Activation Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• 01 Studienregister MasterAdmins

  UniversitaetsSpital Zuerich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: April 11, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 18, 2016

Record last verified: 2016-01

Locations

CH (3)