Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines
- Conditions
- Chronic Inducible UrticariaCINDUCIND
- Registration Number
- LBCTR2022014919
- Lead Sponsor
- ovartis Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 8
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: Change from baseline in Total Fric Score in participants with symptomatic dermographism;Timepoints: Week 12;Measure: Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1);Name: Change from baseline in critical temperature threshold in participants with cold urticaria;Timepoints: Week 12;Measure: The Temptest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature sufficient for inducing symptoms.;Name: Change from baseline in itch numerical rating scale in participants with cholinergic urticaria;Timepoints: Week 12;Measure: Itch numerical rating scale, a scale from 0 to 10
- Secondary Outcome Measures
Name Time Method