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?
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
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.
Start Date: January 2014
Completed Date: June 2017
Phase: Phase 2
Primary Outcome: Negativization of the exercise challenge test
Secondary Outcome: Quality of life
Study sponsors, principal investigator, and references
Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Collaborator: Hospital Clinic of Barcelona
Abajian M, Młynek A, Maurer M. Physical urticaria. Curr Allergy Asthma Rep. 2012 Aug;12(4):281-7. doi: 10.1007/s11882-012-0269-0. Review.