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Cholinergic Urticaria | Efficacy Study of Omalizumab in Cholinergic Urticaria

Cholinergic Urticaria research study

What is the primary objective of this study?

To demonstrate the efficacy and safety of Omalizumab in a new indication, that is cholinergic urticaria.

Who is eligible to participate?

Inclusion Criteria: Adult female and male patients (age 14 years or older). Diagnosis of cholinergic urticaria trough clinical history and positive challenge test. Non-respondent to supra therapeutic doses of antihistamines (defined as 2x the maximal dose included in the drug labeling) Written informed consent. Exclusion Criteria: Pruritus related to dermatitis or other skin condition. Any systemic disease that hampers follow up or interpretation of data. Omalizumab treatment within the previous 12 months. Any exclusion criteria included in the drug labeling. Any other conditions that do not allow the accomplishment of the clinical trial requisites, such as the abuse of drugs or alcohol.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cholinergic Urticaria

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Biological:ActiveTwo injections will be administered every four weeks for four months, we will administer 4 doses within 16 weeks

Biological:PlaceboTwo injections will be administered every four weeks for four months, we will administer 4 doses within 16 weeks

Biological:Open labeledTwo injections will be administered every four weeks for 8 months, we will administer 4 doses within 32 weeks

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ActiveOmalizumab 300 mg Subcutaneous route 300 mg dose (independent from total IgE, weight or high)

PlaceboPlacebo Saline serum Subcutaneous route 0.6 ml saline serum with same volume as an active treatment

Open labeledAfter the double blinded period, all patients from both arms will receive the active drug for 8 more months.

Study Status

Completed

Start Date: January 2014

Completed Date: June 2017

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Negativization of the exercise challenge test

Secondary Outcome: Quality of life

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Collaborator: Hospital Clinic of Barcelona

More information:https://clinicaltrials.gov/show/NCT02012387

Abajian M, MÅ‚ynek A, Maurer M. Physical urticaria. Curr Allergy Asthma Rep. 2012 Aug;12(4):281-7. doi: 10.1007/s11882-012-0269-0. Review.

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