Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines
NCT ID: NCT05024058
Last Updated: 2024-06-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
39 participants
INTERVENTIONAL
2021-11-16
2022-08-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ligelizumab low dose, symptomatic dermographism group
Ligelizumab low dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism
Ligelizumab
Ligelizumab treated groups and arms
Ligelizumab high dose, symptomatic dermographism
Ligelizumab high dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism
Ligelizumab
Ligelizumab treated groups and arms
Placebo SC q4W, symptomatic dermographism
Placebo subcutaneous injection every 4 weeks in participants with symptomatic dermographism
Placebo
Placebo treated groups and arms
Ligelizumab low dose, cold urticaria
Ligelizumab low dose subcutaneous injection every 4 weeks in participants with cold urticaria
Ligelizumab
Ligelizumab treated groups and arms
Ligelizumab high dose, cold urticaria
Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cold urticaria
Ligelizumab
Ligelizumab treated groups and arms
Placebo SC q4w, cold urticaria
Placebo subcutaneous injection every 4 weeks in participants with cold urticaria
Placebo
Placebo treated groups and arms
Ligelizumab high dose, cholinergic urticaria
Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cholinergic urticaria
Ligelizumab
Ligelizumab treated groups and arms
Placebo SC q4w, cholinergic urticaria
Placebo subcutaneous injections every 4 weeks in participants with cholinergic urticaria
Placebo
Placebo treated groups and arms
Interventions
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Ligelizumab
Ligelizumab treated groups and arms
Placebo
Placebo treated groups and arms
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Evansville, Indiana, United States
Novartis Investigative Site
North Charleston, South Carolina, United States
Novartis Investigative Site
El Paso, Texas, United States
Novartis Investigative Site
Murray, Utah, United States
Novartis Investigative Site
East Melbourne, Victoria, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Athens, , Greece
Novartis Investigative Site
Debrecen, Hajdú-Bihar, Hungary
Novartis Investigative Site
Pécs, , Hungary
Novartis Investigative Site
Szeged, , Hungary
Novartis Investigative Site
Izhevsk, , Russia
Novartis Investigative Site
Rostov-on-Don, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Stavropol, , Russia
Novartis Investigative Site
Kežmarok, , Slovakia
Novartis Investigative Site
Svidník, , Slovakia
Novartis Investigative Site
Córdoba, Andalusia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Ankara, , Turkey (Türkiye)
Novartis Investigative Site
Istanbul, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Patient Lay Trial Summary
Other Identifiers
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2020-003018-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQGE031E12301
Identifier Type: -
Identifier Source: org_study_id
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