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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05030311
Registration number
NCT05030311
Ethics application status
Date submitted
19/08/2021
Date registered
1/09/2021
Date last updated
16/05/2024
Titles & IDs
Public title
A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines
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Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines
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Secondary ID [1]
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2021-000471-37
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Secondary ID [2]
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CLOU064A2301
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Universal Trial Number (UTN)
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Trial acronym
REMIX-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Spontaneous Urticaria
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0
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Condition category
Condition code
Skin
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0
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Dermatological conditions
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Skin
0
0
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0
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Other skin conditions
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Inflammatory and Immune System
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0
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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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0
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LOU064 (blinded)
Treatment: Drugs - Placebo
Treatment: Drugs - LOU064 (open-label)
Experimental: Arm 1: LOU064 (blinded) - LOU064 (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally open label for 28 weeks. Randomized in a 2:1 ratio (arm 1:arm 2).
Placebo Comparator: Arm 2: LOU064 placebo (blinded) - LOU064 placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally for 28 weeks. Randomized in a 2:1 ratio (arm 1:arm 2).
Treatment: Drugs: LOU064 (blinded)
LOU064 (blinded) active treatment
Treatment: Drugs: Placebo
Placebo
Treatment: Drugs: LOU064 (open-label)
LOU064 (open-label) active treatment
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Intervention code [1]
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Treatment: Drugs
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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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Change from baseline in UAS7 (Scenario 1 with UAS7 as primary efficacy endpoint)
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Assessment method [1]
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To demonstrate that remibrutinib is superior to placebo in CSU with respect to change from baseline in UAS7 at Week 12 by assessing absolute change from baseline in weekly Urticaria Activity Score (UAS7) at week 12.
The UAS7 is a scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
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Timepoint [1]
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12 weeks
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Primary outcome [2]
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Absolute change in ISS7 and absolute change in HSS7 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)
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Assessment method [2]
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To demonstrate that remibrutinib is superior to placebo in CSU with respect to change from baseline in ISS7 and HSS7 at Week 12 by assessing absolute change from baseline in weekly Itch Severity Score (ISS7) and weekly Hive Severity Score (HSS7) at week 12.
The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The HSS7 score is the wheal/hives severity score for 7 days and the ISS7 is the itch severity score for 7 days, both these scores range from 0 to 21.
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Timepoint [2]
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12 weeks
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Secondary outcome [1]
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Change from baseline in UAS7 (only in scenario 2)
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Assessment method [1]
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To demonstrate that remibrutinib is superior to placebo in CSU with respect to change from baseline in UAS7 at Week 12 by assessing absolute change from baseline in UAS7 at week 12.
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Timepoint [1]
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12 weeks
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Secondary outcome [2]
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Sustained disease activity control (UAS7 =6)
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Assessment method [2]
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To demonstrate that remibrutinib treated participants maintain disease activity control (defined as UAS7=6) for more weeks compared to placebo treated participants over 12 weeks by assessing cumulative number of weeks with an UAS7 = 6 response between baseline and Week 12.
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Timepoint [2]
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12 weeks
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Secondary outcome [3]
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Complete absence of hives and itch (UAS7 = 0)
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Assessment method [3]
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To demonstrate that a greater proportion of participants achieve complete absence of hives and itch (UAS7 = 0) at Week 12 who are treated with remibrutinib compared to placebo-treated participants by assessing achievement of UAS7 at week 12.
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Timepoint [3]
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12 weeks
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Secondary outcome [4]
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Reduction of weekly ISS score (only in scenario 1)
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Assessment method [4]
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To demonstrate the superiority of remibrutinib treated participants with respect to a reduction from baseline in the weekly itch severity score at Week 12 compared to placebo-treated participants by assessing absolute change from baseline in ISS7 score.
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Timepoint [4]
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12 weeks
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Secondary outcome [5]
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Reduction of weekly HSS score (only in scenario 1)
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Assessment method [5]
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To demonstrate the superiority of remibrutinib treated participants with respect to a reduction from baseline in the weekly hive severity score at Week 12 compared to placebo-treated participants by assessing absolute change from baseline in HSS7 score.
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Timepoint [5]
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12 weeks
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Secondary outcome [6]
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Early onset of disease control (UAS7 = 6 at week 2)
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Assessment method [6]
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To demonstrate that a greater proportion of participants achieve UAS7 = 6 at Week 2 who are treated with remibrutinib compared to placebo-treated participants by assessing achievement of UAS = 6 at week 2.
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Timepoint [6]
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2 weeks
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Secondary outcome [7]
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Disease activity control (UAS7 = 6)
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Assessment method [7]
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To demonstrate that a greater proportion of participants achieve disease activity control (UAS7 = 6) at Week 12 who are treated with remibrutinib compared to placebo-treated participants by assessing achievement of UA7 = 6 at week 12.
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Timepoint [7]
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12 weeks
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Secondary outcome [8]
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Achievement of DLQI = 0 - 1
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Assessment method [8]
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To demonstrate that a greater proportion of participants who are treated with remibrutinib achieve DLQI = 0-1 at Week 12 compared to placebo-treated participants by assessing achievement of DLQI = 0 - 1 at week 12.
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Timepoint [8]
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12 weeks
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Secondary outcome [9]
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Number of weeks without angioedema (AAS = 0)
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Assessment method [9]
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To demonstrate that remibrutinib treated participants have more angioedema occurrence-free weeks over 12 weeks compared with placebo-treated participants by assessing the cumulative number of weeks with an AAS = 0 response between baseline and week 12.
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Timepoint [9]
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12 weeks
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Secondary outcome [10]
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Number of participants with Adverse Events
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Assessment method [10]
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To demonstrate the safety and tolerability of remibrutinib by assessing the occurrence of treatment emergent adverse events and serious adverse events during the study.
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Timepoint [10]
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56 weeks
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Eligibility
Key inclusion criteria
- Signed informed consent must be obtained prior to participation in the study.
- Male and female adult participants =18 years of age.
- CSU duration for = 6 months prior to screening (defined as the onset of CSU determined
by the investigator based on all available supporting documentation).
- Diagnosis of CSU inadequately controlled by second generation H1 antihistamines at the
time of randomization defined as:
- The presence of itch and hives for =6 consecutive weeks prior to screening despite the
use of second generation H1-antihistamines during this time period
- UAS7 score (range 0-42) =16, ISS7 score (range 0-21) = 6 and HSS7 score (range 0-21) =
6 during the 7 days prior to randomization (Day 1)
- Documentation of hives within three months before randomization (either at screening
and/or at randomization; or documented in the participants medical history).
- Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration
of the study and adhere to the study protocol.
- Participants must not have had more than one missing UPDD entry (either morning or
evening) in the 7 days prior to randomization (Day 1).
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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
- Participants having a clearly defined predominant or sole trigger of their chronic
urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic
dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-,
cholinergic-, or contact-urticaria
- Other diseases with symptoms of urticaria or angioedema, including but not limited to
urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis,
hereditary urticaria, or drug-induced urticaria
- 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 or psoriasis
- Evidence of clinically significant cardiovascular (such as but not limited to
myocardial infarction, unstable ischemic heart disease, New York heart association
(NYHA) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension
within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal,
hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or
immunodeficiency that, in the investigator's opinion, would compromise the safety of
the participant, interfere with the interpretation of the study results or otherwise
preclude participation or protocol adherence of the participant
- Significant bleeding risk or coagulation disorders
- History of gastrointestinal bleeding, e.g. in association with use of nonsteroidal
anti-inflammatory drugs (NSAID), that was clinically relevant (e.g. requiring
hospitalization or blood transfusion)
- Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100
mg/d or clopidogrel. The use of dual anti-platelet therapy (e.g. acetylsalicylic acid
+ clopidogrel) is prohibited.
- Requirement for anticoagulant medication (for example, warfarin or Novel Oral
Anti-Coagulants (NOAC))
- History or current hepatic disease including but not limited to acute or chronic
hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/ Alanine
Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or
International Normalized Ratio (INR) of more than 1.5 at screening
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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 administering 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
Completed
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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
30/11/2021
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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
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Actual
19/01/2024
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Sample size
Target
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Accrual to date
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Final
470
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Sydney
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Novartis Investigative Site - East Melbourne
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Novartis Investigative Site - Parkville
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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3002 - East Melbourne
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Recruitment postcode(s) [3]
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3002 - Parkville
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Recruitment outside Australia
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to establish the efficacy, safety, and tolerability of
remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria
(CSU) inadequately controlled by H1-antihistamines in comparison to placebo.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05030311
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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 scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05030311
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