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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/NCT05513001




Registration number
NCT05513001
Ethics application status
Date submitted
22/08/2022
Date registered
23/08/2022
Date last updated
22/05/2024

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
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
Secondary ID [1] 0 0
2022-001034-11
Secondary ID [2] 0 0
CLOU064A2303B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Spontaneous Urticaria 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first composite event (i.e., relapse (UAS7=16)
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Number of participants with treatment-emergent (serious and non-serious) adverse events
Timepoint [1] 0 0
160 weeks

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/08/2027
Actual
Sample size
Target
1021
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - East Melbourne
Recruitment hospital [2] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
3002 - Parkville
Recruitment outside Australia
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United States of America
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Alabama
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Pleven
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Thailand
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Bangkok
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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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Istanbul
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Izmir
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Kayseri
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Samsun
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Talas / Kayseri
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United Kingdom
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Cardiff

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05513001
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05513001