A randomized, placebo-controlled, double blind, parallel design study of Xolair (omalizumab) for the management of treatment-resistant systemic and cutaneous mastocytosis.

In patients with systemic and/or cutaneous mastocytosis, is omalizumab (Xolair) in addition to standard care more effective in the management of symptoms than standard care alone? A randomized, placebo-controlled, double blind, parallel design study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001096741

Enrollment

Registered

2013-10-01

Start date

2014-11-05

Completion date

2016-10-13

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study aims to assess the effect of omalizumab (Xolair) on systemic and cutaneous mastocytosis

Interventions

Omalizumab (Xolair) 375mg subcutaneously every 4 weeks for 6 months Trial medication with be administered in hospital

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Over 18 years of age; 2. A diagnosis of Indolent Systemic Mastocytosis, OR Smouldering Systemic Mastocytosis, OR Aggressive Systemic Mastocytosis, OR Cutaneous Mastocytosis as per WHO current guidelines, with satisfaction of Valent 2007 criteria for Mastocytosis in the Skin (Valent P, Akin C, Escribano L et. al. Standards and Standardization in Mastocytosis: Consensus Statements on Diagnosis, Treatment Recommendations and Response Criteria. Eur J Clin Invest 2007, 37 (6); 435 – 453.); 3. Breakthrough symptoms of disease despite maximal tolerated conventional therapy.

Exclusion criteria

1. Pregnancy (a beta-HCG and pregnancy counseling will be performed for all female patients of child-bearing age). 2. Terminal illness 3. Associated haematological clonal non-mast cell lineage disease or mast cell leukaemia 4. Beta blocker use 5. Unable to give consent 6. Known sensitivity to study drug(s) or class of study drug(s) 7. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required) 8. Use of any other investigational agent in the last 30 days

Outcome results