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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05030311




Registration number
NCT05030311
Ethics application status
Date submitted
19/08/2021
Date registered
1/09/2021

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
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
Secondary ID [1] 0 0
2022-001034-11
Secondary ID [2] 0 0
CLOU064A2301
Universal Trial Number (UTN)
Trial acronym
REMIX-1
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 25 mg (b.i.d)
Treatment: Drugs - Placebo
Treatment: Drugs - LOU064 25 mg (b.i.d) as a tablet.

Experimental: LOU064 25mg b.i.d. - Patients initially randomized to Remibrutinib during the Double-blind treatment period and continued Remibrutinib during the Open-label treatment period (Up to Week 52)

Placebo comparator: Placebo - Patients initially randomized to Placebo (Up to Week 24)


Treatment: Drugs: LOU064 25 mg (b.i.d)
LOU064 25 mg was administered by oral route twice a day (b.i.d) as a tablet.

Treatment: Drugs: Placebo
Placebo

Treatment: Drugs: LOU064 25 mg (b.i.d) as a tablet.
LOU064 25 mg was administered by oral route twice a day (b.i.d) as a tablet in open label phase.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Weekly Urticaria Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint)
Timepoint [1] 0 0
Baseline, Week 12
Primary outcome [2] 0 0
Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints)
Timepoint [2] 0 0
Baseline, Week 12
Primary outcome [3] 0 0
Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints)
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Number of Patients Who Achieved Disease Activity Control (UAS7 =6)
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Number of Patients Who Achieved Complete Absence of Hives and Itch (UAS7 = 0)
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Number of Patients With Early Onset of Disease Control (UAS7 = 6 at Week 2)
Timepoint [3] 0 0
Week 2
Secondary outcome [4] 0 0
Cumulative Number of Weeks With Disease Activity Control (UAS7 <= 6) up to Week 12
Timepoint [4] 0 0
up to Week 12
Secondary outcome [5] 0 0
Number of Patients Who Achieved DLQI = 0 - 1
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Cumulative Number of Weeks Without Angioedema (AAS7 = 0)
Timepoint [6] 0 0
Up to Week 12
Secondary outcome [7] 0 0
Number of Participants With Adverse Events
Timepoint [7] 0 0
On-treatment adverse events are reported from first dose of study medication up to 28 days after last dose of study medication, for a timeframe up to approximately 56 weeks

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

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/01/2024
Sample size
Target
Accrual to date
Final
470
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Sydney
Recruitment hospital [2] 0 0
Novartis Investigative Site - East Melbourne
Recruitment hospital [3] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Argentina
State/province [16] 0 0
Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Nueve De Julio
Country [18] 0 0
Argentina
State/province [18] 0 0
Rosario
Country [19] 0 0
Argentina
State/province [19] 0 0
Santa Fe
Country [20] 0 0
Argentina
State/province [20] 0 0
Bahia Blanca
Country [21] 0 0
Argentina
State/province [21] 0 0
Capital Federal
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Pleven
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Bulgaria
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Sofia
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Colombia
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Antioquia
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Colombia
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Atlantico
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Colombia
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Barranquilla
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Colombia
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Bogota
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Czechia
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Czech Republic
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Czechia
State/province [29] 0 0
CZE
Country [30] 0 0
Czechia
State/province [30] 0 0
Plzen
Country [31] 0 0
Czechia
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Praha 5
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France
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Antony
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France
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Bordeaux Cedex
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France
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Nice
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France
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Pierre Benite
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France
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Reims
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France
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Rouen
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Hungary
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Hajdu Bihar
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Hungary
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Debrecen
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Hungary
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Szeged
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India
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Delhi
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India
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Maharashtra
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India
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Telangana
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India
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Uttar Pradesh
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India
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West Bengal
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India
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Belgavi
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India
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Chandigarh
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Italy
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AN
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Italy
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MI
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Italy
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PI
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Italy
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TO
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Japan
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Hokkaido
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Japan
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Kanagawa
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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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Tokyo
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Japan
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Fukuoka
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Japan
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Hiroshima
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Korea, Republic of
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Dalseo Gu
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Korea, Republic of
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Gyeonggi Do
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Tabasco
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Puerto Rico
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Carolina
Country [68] 0 0
Puerto Rico
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San Juan
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Russian Federation
State/province [69] 0 0
Izhevsk
Country [70] 0 0
Singapore
State/province [70] 0 0
Singapore
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Spain
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Catalunya
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Spain
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Comunidad Valenciana
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Spain
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Las Palmas de Gran Canaria
Country [74] 0 0
Spain
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Madrid
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Spain
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Valencia
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Taiwan
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Taipei
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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
Country [83] 0 0
Turkey
State/province [83] 0 0
Talas Kayseri

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05030311