Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT05024058
Eligibility Criteria:
Inclusion Criteria:
* Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for ≥ 4 months.
* Diagnosis of CINDU (symptomatic dermographism, cold urticaria or cholinergic urticaria) inadequately controlled with H1-AH at local label approved doses at the time of randomization, as defined by all of the following:
* Positive response (i.e development of symptoms) to triggers despite treatment with H1-AH
* Positive response (i.e. development of symptoms) to provocation test on day of randomization
* Participants must be able to physically perform the protocol defined provocation test specific to the participant's CINDU.
* Cholinergic urticaria participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.
* Willing and able to complete a daily symptom eDiary as per protocol requirement and adhere to the study visit schedules
Exclusion Criteria:
* History of hypersensitivity to any of the study drugs or its components or to drugs of similar chemical classes or to the provocation test or items used in provocation tests
* Participants who have concomitant CSU at screening
* Participants who have a familial form of the target CINDU that is being considered for the participant's inclusion in this study
* Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study
* Diseases, other than chronic inducible urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
* Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism
* Prior exposure to ligelizumab, omalizumab and or other anti-IgE therapies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT05024058
Study Brief:
Protocol Section:
NCT05024058