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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05513001
Registration number
NCT05513001
Ethics application status
Date submitted
22/08/2022
Date registered
23/08/2022
Titles & IDs
Public title
An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib
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Scientific title
A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal and Open-label Extension Study Followed by Long-term Open-label Treatment Cycles to Assess the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Chronic Spontaneous Urticaria Patients Who Completed the Preceding Remibrutinib Phase 3 Studies
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Secondary ID [1]
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2022-001034-11
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Secondary ID [2]
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CLOU064A2303B
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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 Spontaneous Urticaria
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0
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Condition category
Condition code
Skin
0
0
0
0
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Dermatological conditions
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Skin
0
0
0
0
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Other skin conditions
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Inflammatory and Immune System
0
0
0
0
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Allergies
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Inflammatory and Immune System
0
0
0
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 cycles of either LOU064 (open-label) taken orally for a maximum of 5 cycles of 24 weeks each OR treatment-free observation cycles. Randomized in a 1:1 ratio (arm 1:arm 2)
Placebo comparator: Arm 2: LOU064 Placebo (blinded) - LOU064 placebo (blinded) taken orally for 24 weeks, followed by cycles of either LOU064 (open-label) taken orally for a maximum of 5 cycles of 24 weeks each OR treatment-free observation cycles. Randomized in a 1:1 ratio (arm 1:arm 2)
Experimental: Arm 3: LOU064 (Open Label) - LOU064 (open-label) taken orally for 24 weeks per treatment cycle (Arm 3)
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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Time to first composite event (i.e., relapse (UAS7=16)
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Assessment method [1]
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The efficacy of remibrutinib in CSU participants with a UAS7\<16 at Week 52 in the prior core study with respect to time to first of the three events: relapse or study treatment discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication up to Week 24 compared to placebo. (Epoch 1)
Time to first composite event (i.e., relapse (UAS7=16), study treatment discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication) during the randomized withdrawal period (Epoch 1)
Urticaria Activity Score (UAS7) describes the number of hives with 0 being No Hives and 3 is most severe. The final score is calculated by adding together daily scores which can range from 0-6 for 7 days. The resulting maximum score is then 42.
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Timepoint [1]
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24 weeks
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Secondary outcome [1]
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Number of participants with treatment-emergent (serious and non-serious) adverse events
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Assessment method [1]
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Occurrence of treatment-emergent (serious and non-serious) adverse events
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Timepoint [1]
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160 weeks
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Eligibility
Key inclusion criteria
* Written informed consent must be obtained before any assessment is performed.
* Male and female, adult participants =18 years of age.
* Participants who successfully completed the preceding core studies CLOU064A2301, CLOU064A2302, CLOU064A1301, CLOU064A2304 or CLOU064A2305 according to the respective protocols.
* Willing and able to adhere to the study protocol and visit schedule.
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Minimum age
18
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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
* Significant bleeding risk or coagulation disorders.
* History of gastrointestinal bleeding.
* Requirement for anti-platelet medication.
* Requirement for anticoagulant medication.
* History or current hepatic disease.
* Evidence of clinically significant cardiovascular, 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.
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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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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
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
9/12/2022
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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
10/08/2027
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Actual
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Sample size
Target
1021
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Novartis Investigative Site - East Melbourne
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Recruitment hospital [2]
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Novartis Investigative Site - Parkville
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3002 - East Melbourne
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Recruitment postcode(s) [2]
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3002 - Parkville
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Recruitment outside Australia
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Thailand
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Phayathai
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Thailand
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THA
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Thailand
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Chiang Mai
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Turkey
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Aydin
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kayseri
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Turkey
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Sakarya
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Turkey
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Samsun
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Turkey
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Talas / Kayseri
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United Kingdom
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Cardiff
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Ethics approval
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Summary
Brief summary
The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 studies. This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.
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Trial website
https://clinicaltrials.gov/study/NCT05513001
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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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Phone
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1-888-669-6682
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Email
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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 with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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/NCT05513001