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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05976243
Registration number
NCT05976243
Ethics application status
Date submitted
28/07/2023
Date registered
4/08/2023
Titles & IDs
Public title
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
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Scientific title
A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled, Basket Study With an Open-label Extension to Investigate the Efficacy, Safety, and Tolerability of Remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in Adults Inadequately Controlled by H1-antihistamines
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Secondary ID [1]
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2023-505739-12-00
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Secondary ID [2]
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CLOU064M12301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Inducible Urticaria
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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0
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Allergies
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Remibrutinib
Other interventions - Placebo
Experimental: Remibrutinib, symptomatic dermographism group - Remibrutinib oral twice daily in participants with symptomatic dermographism
Placebo comparator: Placebo, symptomatic dermographism group - Placebo oral twice daily, symptomatic dermographism
Experimental: Remibrutinib, cold urticaria group - Remibrutinib oral twice daily, cold urticaria
Placebo comparator: Placebo, cold urticaria group - Placebo oral twice daily, cold urticaria
Experimental: Remibrutinib, cholinergic urticaria group - Remibrutinib oral twice daily, cholinergic urticaria
Placebo comparator: Placebo, cholinergic urticaria - Placebo oral twice daily, cholinergic urticaria
Treatment: Drugs: Remibrutinib
Remibrutinib treated groups and arms
Other interventions: Placebo
Placebo treated groups and arms
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of participants with complete response in Total Fric Score; symptomatic dermographism
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Assessment method [1]
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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)
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Timepoint [1]
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Week 12
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Primary outcome [2]
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Proportion of participants with complete response in critical temperature threshold; cold urticaria
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Assessment method [2]
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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 that induces symptoms.
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Timepoint [2]
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Week 12
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Primary outcome [3]
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Proportion of participants with itch numerical rating scale =0; cholinergic urticaria
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Assessment method [3]
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Itch numerical rating scale, a scale from 0 to 10
Patients are asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst itch imaginable")
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Timepoint [3]
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Week 12
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Secondary outcome [1]
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Change from baseline in Total Fric score; symptomatic dermographism
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Assessment method [1]
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Total Fric score, a scale from 0-4 where a positive response with all four pins is TFS=4, while a positive only 1 pin - the largest pin is TFS=1
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Change from baseline in criticial temperature threshold following Temptest; cold urticaria
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Assessment method [2]
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Critical temperature threshold, as measured by the Temptest, determines the highest temperature that induces symptoms
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Change from baseline in itch numerical rating scale; cholinergic urticaria
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Assessment method [3]
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Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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proportion of participants with Physician Global Assessment (PGA) severity of hives =0; cholinergic urticaria
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Assessment method [4]
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Physician global assessment of severity of hives. This assessment is scored 0 to 4 with 0=no hives, 1=mild hives, 2=moderate hives, 3=severe hives and 4=very severe hives
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Proportion of participants with complete response in TFS; symptomatic dermographism
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Assessment method [5]
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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)
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Timepoint [5]
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Week 24
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Secondary outcome [6]
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Proportion of participants with complete response in Critical Temperature threshold; cold urticaria
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Assessment method [6]
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Critical Temperature Threshold, as measured by the Temptest, is the highest temperature that induces symptoms
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Timepoint [6]
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Week 24
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Secondary outcome [7]
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Proportion of participants with complete response in itch numerical rating scale; cholinergic urticaria
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Assessment method [7]
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Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
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Timepoint [7]
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Week 24
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Secondary outcome [8]
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Change from baseline in itch numerical rating scale in participants with symptomatic dermographism
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Assessment method [8]
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Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
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Timepoint [8]
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Week 12
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Secondary outcome [9]
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Change from baseline in itch numerical rating scale in participants with cold urticaria
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Assessment method [9]
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Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
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Timepoint [9]
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Week 12
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Secondary outcome [10]
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Proportion of participants with complete response in Total Fric score; symptomatic dermographism
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Assessment method [10]
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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)
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Timepoint [10]
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Week 2
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Secondary outcome [11]
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Proportion of participants with complete response in Critical Temperature Threshold; cold urticaria
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Assessment method [11]
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Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.
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Timepoint [11]
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Week 2
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Secondary outcome [12]
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Proportion of participants with itch NRS=0; cholinergic urticaria
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Assessment method [12]
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Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
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Timepoint [12]
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Week 2
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Secondary outcome [13]
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Change from baseline in TFS in participants with symptomatic dermographism
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Assessment method [13]
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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)
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Timepoint [13]
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Week 2
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Secondary outcome [14]
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Change from baseline in Critical Temperature Threshold in participants with cold urticaria
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Assessment method [14]
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Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.
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Timepoint [14]
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Week 2
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Secondary outcome [15]
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Change from baseline in itch NRS in participants with cholinergic urticaria
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Assessment method [15]
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Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
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Timepoint [15]
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Week 2
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Secondary outcome [16]
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Change from baseline in itch NRS in participants with symptomatic dermographism
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Assessment method [16]
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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)
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Timepoint [16]
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Week 2
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Secondary outcome [17]
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Change from baseline in itch NRS in participants with cold urticaria
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Assessment method [17]
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Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
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Timepoint [17]
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Week 2
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Secondary outcome [18]
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Proportion of participants with cholinergic urticaria with PGA=0
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Assessment method [18]
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Physician global assessment of severity of hives is a 4-point scale (0 = no active disease, 1 = mild disease, 2 = moderate disease, 3 = severe disease).
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Timepoint [18]
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Week 2
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Secondary outcome [19]
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Change from baseline in weekly most bothersome symptom NRS score on the USDD
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Assessment method [19]
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Urtricara symptom daily diary (USDD). This daily diary records if the participant experiences any symptoms or avoided the triggers
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Timepoint [19]
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Week 12
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Secondary outcome [20]
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Proportion of participants with DLQI=0-1
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Assessment method [20]
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The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score is calculated and ranges from 0 to 30 (higher score meaning worse disease-related QoL). A DLQI score of 0 or 1 means that there is no impact of a skin disease on the patient's life.
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Timepoint [20]
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Week 12
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Secondary outcome [21]
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Occurrence of treatment emergent adverse events and serious adverse events during the study
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Assessment method [21]
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Treatment emergent adverse events and serious adverse events are those that occur at any time only after treatment has started
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Timepoint [21]
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Week 52
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Eligibility
Key inclusion criteria
Inclusion Criteria for core period:
1. Male and female participants =18 years of age at the time of signing of the ICFs
2. Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for = 4 months (defined as onset of CINDU with supporting documentation (e.g medical record, clinical history, photographs)) and inadequate control with H1-AH at local label approved doses at the time of randomization
3. The following response to the provocation test for each subtype is required at the randomization visit :
* Symptomatic Dermographism: A Total Fric Score of =3 using the FricTest® 4.0 and a numerical rating scale score of =5 for itch after the provocation test.
* Cold Urticaria: A Critical Threshold Temperature of =15°C using the TempTest® 4.0 and a numerical rating scale score of =5 for itch after the provocation test.
* Cholinergic Urticaria: A physician global assessment of severity of hives = 2 using the Pulse-controlled ergometry test and a numerical rating scale score of =5 for itch after the provocation test.
4. Cold Urticaria: Positive ice-cube test resulting in hives at the provocation site for participants at Screening.
5. Cholinergic urticaria: Participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.
Inclusion criteria for the OLE:
1. Participants who have completed the Core period up to Week 52 and are willing to enter the OLE period
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria for core period:
* 1. Previous use of remibrutinib or other BTK inhibitors.
2. Participants who have concomitant CSU at screening. Participants with resolved CSU at the time of screening can be included in the study.
3. Participants who have a familial form (e.g familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study.
4. 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.
5. Diseases, other than chronic inducible urticaria, with urticaria or angioedema symptoms including but not limited to urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema
6. Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism
There are no exclusion criteria for OLE
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/12/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2028
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Actual
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Sample size
Target
348
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Woolloongabba
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Recruitment hospital [2]
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Novartis Investigative Site - Carlton
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Recruitment hospital [3]
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Novartis Investigative Site - Melbourne
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Recruitment postcode(s) [1]
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4102 - Woolloongabba
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Recruitment postcode(s) [2]
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3053 - Carlton
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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Alabama
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Nebraska
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Ohio
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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South Carolina
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Texas
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Utah
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Brazil
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Sao Paulo
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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China
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Fujian
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China
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Guangdong
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China
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Guangzhou
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China
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Hunan
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China
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Jiangsu
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China
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Jilin
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China
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Shandong
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China
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Sichuan
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China
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Xinjiang
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China
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Zhejiang
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China
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Beijing
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China
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Chongqing
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China
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Jinan
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China
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Nanjing
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China
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Shanghai
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China
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Tianjin
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Colombia
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Atlantico
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Colombia
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Barranquilla
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Hong Kong
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Hong Kong
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Japan
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Fukuoka
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Japan
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Kumamoto
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Japan
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Osaka
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Japan
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Shimane
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Japan
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Tokyo
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Japan
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Hiroshima
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Korea, Republic of
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Gyeonggi Do
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Korea, Republic of
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Seoul
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Malaysia
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Johor
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Malaysia
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Perak
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Malaysia
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Wilayah Persekutuan
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Malaysia
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0
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Penang
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Singapore
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Singapore
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0
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Thailand
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Bangkok
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Thailand
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Phayathai
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0
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Thailand
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Chiang Mai
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0
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Turkey
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Istanbul
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0
0
Turkey
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0
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Sakarya
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Country [67]
0
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Turkey
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State/province [67]
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Talas Kayseri
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE). The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs). The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data on remibrutinib in participants after having completed the Core period
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Trial website
https://clinicaltrials.gov/study/NCT05976243
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for public queries
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Novartis Pharmaceuticals
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1-888-669-6682
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05976243