Multicenter randomized, double-blind, placebo-controlled parallel clinical trial to assess efficacy and safety of Omalizumab (Xolair®) in a new indication: cholinergic urticaria.

Multicenter randomized, double-blind, placebo-controlled parallel clinical trial to assess efficacy and safety of Omalizumab (Xolair®) in a new indication: cholinergic urticaria. - CUN-OMAL-UCOL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002770-43-ES

Enrollment

Registered

2013-08-14

Start date

2013-10-28

Completion date

Unknown

Last updated

2017-07-03

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

Conditions

Cholinergic urticaria

Interventions

Trade Name: Xolair 150 mg solución inyectable Omalizumab Pharmaceutical Form: Dispersion for injection INN or Proposed INN: OMALIZUMAB CAS Number: 242138-07-4 Concentration unit: mg milligram(s) Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult female and male patients (age 14 years or older). - Diagnosis of cholinergic urticaria trough clinical history and positive exercise challenge test. - Non-respondent to supra therapeutic doses of antihistamines (defined as two folds the maximal dose included in the drug labeling) - Written informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: 24 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24

Exclusion criteria

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 contraindication 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.

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Secondary end point(s) - Quality of Life: - QoL will be evaluated through the Spanish validated version of Chronic Urticaria quality of life (CU-Q2oL) - Patient?s card: - Use of medication, VAS, daily symptoms, emergency visits, days off work. - Treatment drops off in each sequence. - Adverse events.;Timepoint(s) of evaluation of this end point: To better assess the safety of the medication in the indication under study, the blind clinical trial comprising 4 months will be followed by an open label period of 8 months in which all patients will receive the active drug (pharmacovigilance period).	—

Measure

Time frame

Secondary end point(s): Secondary end point(s) - Quality of Life: - QoL will be evaluated through the Spanish validated version of Chronic Urticaria quality of life (CU-Q2oL) - Patient?s card: - Use of medication, VAS, daily symptoms, emergency visits, days off work. - Treatment drops off in each sequence. - Adverse events.;Timepoint(s) of evaluation of this end point: To better assess the safety of the medication in the indication under study, the blind clinical trial comprising 4 months will be followed by an open label period of 8 months in which all patients will receive the active drug (pharmacovigilance period).

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Primary

Measure	Time frame
Main Objective: Our primary endpoint will be the negativization of the exercise challenge test: We will perform the exercise challenge test following the European Guidelines;Secondary Objective: - Quality of Life: QoL will be assessed through the Spanish validated version of Chronic Urticaria quality of life (CU-Q2oL) - Patient?s card: Use of medication, VAS, daily symptoms, emergency visits, days off work. - Treatment drops off in each sequence. - Adverse events.;Primary end point(s): - Primary and secondary endpoints/outcome measures Our primary endpoint will be the negativization of the exercise challenge test - We will perform the exercise challenge test following the European Guidelines[14] for cholinergic urticaria. According with such guidelines, all centers will follow the same center standardized protocol. The patient will exercise in treadmill or running to the point of sweating and following for 15 more minutes, wearing warm clothing in a warm room. The test will be considered positive if exercise challenge leads to the typical rash over 10 minutes.;Timepoint(s) of evaluation of this end point: To better assess the safety of the medication in the indication under study, the blind clinical trial comprising 4 months will be followed by an open label period of 8 months in which all patients will receive the active drug (pharmacovigilance period).	—

Measure

Time frame

Main Objective: Our primary endpoint will be the negativization of the exercise challenge test: We will perform the exercise challenge test following the European Guidelines;Secondary Objective: - Quality of Life: QoL will be assessed through the Spanish validated version of Chronic Urticaria quality of life (CU-Q2oL) - Patient?s card: Use of medication, VAS, daily symptoms, emergency visits, days off work. - Treatment drops off in each sequence. - Adverse events.;Primary end point(s): - Primary and secondary endpoints/outcome measures Our primary endpoint will be the negativization of the exercise challenge test - We will perform the exercise challenge test following the European Guidelines[14] for cholinergic urticaria. According with such guidelines, all centers will follow the same center standardized protocol. The patient will exercise in treadmill or running to the point of sweating and following for 15 more minutes, wearing warm clothing in a warm room. The test will be considered positive if exercise challenge leads to the typical rash over 10 minutes.;Timepoint(s) of evaluation of this end point: To better assess the safety of the medication in the indication under study, the blind clinical trial comprising 4 months will be followed by an open label period of 8 months in which all patients will receive the active drug (pharmacovigilance period).

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Countries

Spain

Contacts

Public ContactUCICEC

Clínica Universidad de Navarra

ucicec@unav.es34948255 4001142

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026