A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistamines (REMIX-2)

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

The purpose of this study was to establish the efficacy, safety, and tolerability of Remibrutinib 25 mg b.i.d. in adult patients suffering from chronic spontaneous urticaria (CSU) inadequately controlled by second generation H1-antihistamines (H1-AHs) in comparison to placebo.

Study Overview

• Status: Completed
• Conditions: Chronic Spontaneous Urticaria
• Intervention / Treatment: Drug: Placebo; Drug: LOU064 (blinded); Drug: LOU064 (open-label)

Detailed Description

The study consisted of four periods, the total study duration was up to 60 weeks: Screening period of up to 4 weeks, Double-blind placebo-controlled treatment period of 24 weeks, Open-label treatment period with Remibrutinib period of 28 weeks, and treatment free follow-up period of 4 weeks.

The design of this study was a replicate of another Phase III study, CLOU046A2301 (NCT05030311).

The study population consisted of female and male adult patients with CSU inadequately controlled by second generation H1-AHs at least at a locally label approved dose. All patients were on a stable, locally label approved dose of a second generation H1 AH (background therapy) throughout the entire study (starting a minimum of 7 days prior to randomization until the end of the study). To treat unbearable symptoms of CSU, patients were allowed to use another second generation H1-AH on an as-needed basis (rescue therapy). Eligible patients were randomly assigned to the treatment arms in a 2:1 ratio to remibrutinib or placebo arm (300 in the remibrutinib arm and 150 in placebo arm) and stratified based on prior exposure to anti-IgE biologics for CSU and geographic region.

An extension Phase IIIb study, CLOU064A2303B (NCT05513001), was initiated to allow CLOU064A2302 eligible patients to roll over after completion of the open-label treatment period.

There were two distinct testing strategies (scenario 1 with Weekly Urticaria Activity Score (UAS7) as the primary efficacy endpoint and scenario 2 with Weekly Itch Severity Score (ISS7) and Weekly Hives Severity Score (HSS7) as the co-primary efficacy endpoints) based on two primary objective scenarios related to regional regulatory precedent and Health Authorities' feedback.

• Study Type: Interventional
• Enrollment (Actual): 455
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Oberoesterreich
    • Linz, Oberoesterreich, Austria, A 4020
      • Novartis Investigative Site
• Brazil
  • SP
    • Sao Bernardo do Campo, SP, Brazil, 09715 090
      • Novartis Investigative Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1C3
      • Novartis Investigative Site
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Novartis Investigative Site
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Novartis Investigative Site
    • London, Ontario, Canada, N6H 5L5
      • Novartis Investigative Site
    • Niagara Falls, Ontario, Canada, L2H 1H5
      • Novartis Investigative Site
    • Ottawa, Ontario, Canada, K1G 6C6
      • Novartis Investigative Site
    • Toronto, Ontario, Canada, M3B 3S6
      • Novartis Investigative Site
  • Quebec
    • Verdun, Quebec, Canada, H4G 3E7
      • Novartis Investigative Site
• China
  • Beijing, China, 100050
    • Novartis Investigative Site
  • Beijing, China, 100191
    • Novartis Investigative Site
  • Shanghai, China, 200040
    • Novartis Investigative Site
  • Shanghai, China, 200443
    • Novartis Investigative Site
  • Tianjin, China, 300052
    • Novartis Investigative Site
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Novartis Investigative Site
    • Guangzhou, Guangdong, China, 510630
      • Novartis Investigative Site
  • Guangzhou
    • Guangdong, Guangzhou, China, 510091
      • Novartis Investigative Site
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Novartis Investigative Site
  • Jiangsu
    • Wuxi, Jiangsu, China, 214002
      • Novartis Investigative Site
  • Jilin
    • Chang Chun, Jilin, China, 130021
      • Novartis Investigative Site
  • Liaoning
    • Shenyang, Liaoning, China, 110011
      • Novartis Investigative Site
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Novartis Investigative Site
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Novartis Investigative Site
    • Hangzhou, Zhejiang, China, 310003
      • Novartis Investigative Site
    • Yi Wu, Zhejiang, China, 322000
      • Novartis Investigative Site
• Denmark
  • Copenhagen NV, Denmark, 2400
    • Novartis Investigative Site
  • Hellerup, Denmark, 2900
    • Novartis Investigative Site
• Germany
  • Bad Bentheim, Germany, 48455
    • Novartis Investigative Site
  • Berlin, Germany, 13353
    • Novartis Investigative Site
  • Berlin, Germany, 13187
    • Novartis Investigative Site
  • Bramsche, Germany, 49565
    • Novartis Investigative Site
  • Dresden, Germany, 01307
    • Novartis Investigative Site
  • Gottingen, Germany, 37075
    • Novartis Investigative Site
  • Halle S, Germany, 06120
    • Novartis Investigative Site
  • Halle Saale, Germany, 06108
    • Novartis Investigative Site
  • Hamburg, Germany, 22391
    • Novartis Investigative Site
  • Langenau, Germany, 89129
    • Novartis Investigative Site
  • Leipzig, Germany, 04103
    • Novartis Investigative Site
  • Luebeck, Germany, 23538
    • Novartis Investigative Site
  • Mainz, Germany, 55131
    • Novartis Investigative Site
  • Marburg, Germany, 35039
    • Novartis Investigative Site
  • Merzig, Germany, 66663
    • Novartis Investigative Site
  • Muenchen, Germany, 81377
    • Novartis Investigative Site
  • Muenchen, Germany, 80377
    • Novartis Investigative Site
  • Tuebingen, Germany, 72076
    • Novartis Investigative Site
• India
  • New Delhi, India, 110029
    • Novartis Investigative Site
  • Surat, India, 395001
    • Novartis Investigative Site
  • Gujarat
    • Ahmedabad, Gujarat, India, 380016
      • Novartis Investigative Site
  • Karnataka
    • Bangalore, Karnataka, India, 571401
      • Novartis Investigative Site
    • Mysore, Karnataka, India, 570001
      • Novartis Investigative Site
  • Maharashtra
    • Nagpur, Maharashtra, India, 440008
      • Novartis Investigative Site
    • Nagpur, Maharashtra, India, 440001
      • Novartis Investigative Site
    • Nashik, Maharashtra, India, 422101
      • Novartis Investigative Site
  • Uttarakhand
    • Dehradun, Uttarakhand, India, 248001
      • Novartis Investigative Site
  • West Bengal
    • Kolkata, West Bengal, India, 700073
      • Novartis Investigative Site
• Malaysia
  • Pulau Pinang, Malaysia, 10990
    • Novartis Investigative Site
  • Wilayah Persekutuan, Malaysia, 62502
    • Novartis Investigative Site
  • Johor
    • Muar, Johor, Malaysia, 84000
      • Novartis Investigative Site
  • Perak
    • Ipoh, Perak, Malaysia, 30450
      • Novartis Investigative Site
  • Wilayah Persekutuan
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
      • Novartis Investigative Site
• Poland
  • Bialystok, Poland, 15 276
    • Novartis Investigative Site
  • Lodz, Poland, 90-265
    • Novartis Investigative Site
  • Poznan, Poland, 60-693
    • Novartis Investigative Site
  • Poznan, Poland, 60-823
    • Novartis Investigative Site
  • Warszawa, Poland, 02-507
    • Novartis Investigative Site
• Russian Federation
  • Ryazan, Russian Federation, 390039
    • Novartis Investigative Site
  • Ryazan, Russian Federation, 390046
    • Novartis Investigative Site
  • St Petersburg, Russian Federation, 196158
    • Novartis Investigative Site
  • St Petersburg, Russian Federation, 199226
    • Novartis Investigative Site
  • Stavropol, Russian Federation, 355000
    • Novartis Investigative Site
• Slovakia
  • Kezmarok, Slovakia, 060 01
    • Novartis Investigative Site
  • Kosice, Slovakia, 041 90
    • Novartis Investigative Site
  • Svidnik, Slovakia, 08901
    • Novartis Investigative Site
  • Topolcany, Slovakia, 95501
    • Novartis Investigative Site
• South Africa
  • Cape Town, South Africa, 7700
    • Novartis Investigative Site
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0009
      • Novartis Investigative Site
  • Western Province
    • Cape Town, Western Province, South Africa, 7700
      • Novartis Investigative Site
• Switzerland
  • Bern, Switzerland, 3010
    • Novartis Investigative Site
  • Zuerich, Switzerland, 8091
    • Novartis Investigative Site
  • Zuerich, Switzerland, 8006
    • Novartis Investigative Site
• Taiwan
  • Taichung, Taiwan, 407219
    • Novartis Investigative Site
  • Taoyuan, Taiwan, 33305
    • Novartis Investigative Site
• Thailand
  • Bangkok, Thailand, 10400
    • Novartis Investigative Site
  • Chiang Mai, Thailand, 50200
    • Novartis Investigative Site
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Novartis Investigative Site
  • THA
    • Khon Kaen, THA, Thailand, 40002
      • Novartis Investigative Site
• United Kingdom
  • Cardiff, United Kingdom, CF14 4XW
    • Novartis Investigative Site
  • Oxford, United Kingdom, OX3 7LE
    • Novartis Investigative Site
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS9 7TF
      • Novartis Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Cahaba Derm and skin hlth ctr 27
  • Arizona
    • Litchfield Park, Arizona, United States, 85340
      • Research Solutions of Arizona
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Allergy and Asthma Clnc
  • California
    • San Diego, California, United States, 92123
      • Allergy and Asthma Medical Group and Research Center
  • Connecticut
    • Farmington, Connecticut, United States, 06030-2840
      • UCONN Health Dermatology
  • Florida
    • Miami, Florida, United States, 33176
      • Miami Dade Medical Research
    • North Miami Beach, Florida, United States, 33162
      • Ziaderm Research LLC
    • Pembroke Pines, Florida, United States, 33028
      • Riverchase Dermatology
    • Tampa, Florida, United States, 33609
      • Trueblue Clinical Research
  • Georgia
    • Savannah, Georgia, United States, 31406
      • AeroAllergy Research Laboratories of Savannah Inc
  • Idaho
    • Boise, Idaho, United States, 83706
      • Treasure Valley Medical Research
  • Illinois
    • Glenview, Illinois, United States, 60077
      • NorthShore University Health System
    • River Forest, Illinois, United States, 60305
      • Asthma and Allergy Center of Chicago S C
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Allergy and Asthma Specialist P S C
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • John Hopkins University
    • White Marsh, Maryland, United States, 21162
      • Chesapeake Clinical Research
  • Michigan
    • Troy, Michigan, United States, 48084
      • Revival Research Institute
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research
  • New Jersey
    • Little Silver, New Jersey, United States, 07739
      • Allergy Asthma Assoc Monmouth
  • North Carolina
    • High Point, North Carolina, United States, 27260
      • Peters Medical Research
  • Ohio
    • Dublin, Ohio, United States, 43016
      • CR Services Acquisition US
    • Mayfield Heights, Ohio, United States, 44124
      • Ohio Clinical Research Associates
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy Asthma and Clinical Research
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy and Clinical Immunology Associates
  • South Carolina
    • North Charleston, South Carolina, United States, 29420
      • National Allergy and Asthma Research LLS
  • Texas
    • San Antonio, Texas, United States, 78229
      • STAAMP Research LLC
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Intermountain Clinical Research
  • Washington
    • Seattle, Washington, United States, 98115
      • Seattle Allergy and Asthma Rsch
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53228
      • Allergy Asthma and amp Sinus Ctr S C
• Vietnam
  • Hanoi, Vietnam, 100000
    • Novartis Investigative Site
  • Ho Chi Minh, Vietnam, 7000
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Signed informed consent must be obtained prior to participation in the study.
• Male and female adult participants >= 18 years of age at the time of screening.
• 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).

Key Exclusion Criteria:

• Participants having a clearly defined predominant or sole trigger of their chronic urticaria (CU) (chronic inducible urticaria (CINDU)) 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LOU064 25mg b.i.d.; LOU064A (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064 (open- label) taken orally b.i.d. for 28 weeks. Randomised in 2:1 ratio (active vs placebo)	Drug: LOU064 (blinded); LOU064 (blinded) active treatment; Other Names: remibrutinib; Drug: LOU064 (open-label); LOU064 (open-label) active treatment; Other Names: remibrutinib
Placebo Comparator: Placebo; LOU064A placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally b.i.d. for 28 weeks. Randomised in 2:1 ratio (active vs placebo)	Drug: Placebo; Placebo; Drug: LOU064 (open-label); LOU064 (open-label) active treatment; Other Names: remibrutinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint)	The Weekly Urticaria Activity Score (UAS7) is a simple 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 (highest urticaria severity), and a minimum possible score of 0. This endpoint is a secondary endpoint for testing strategy Scenario 2 with Weekly Itch Severity Score (ISS7) and Weekly Hives Severity Score (HSS7) as co-primary efficacy endpoints).	Baseline, Week 12
Mean Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints)	The severity of the itch was recorded by the participant twice daily in their electronic Diary, on a scale of 0 (none) to 3 (severe). A weekly score (ISS7) was derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score was therefore 0 - 21 (highest itch severity). This endpoint is a secondary endpoint for testing strategy Scenario 1 with Weekly Urticaria Activity Score (UAS7) as the primary efficacy endpoint).	Baseline, Week 12
Mean Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints)	The hives (wheals) severity score, defined by number of hives, was recorded by the participant twice daily in their electronic Diary, on a scale of 0 (none) to 3 (> 12 hives/12 hours). A weekly score (HSS7) was derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score was therefore 0 - 21 (highest hives activity). This endpoint is a secondary endpoint for testing strategy Scenario 1 with Weekly Urticaria Activity Score (UAS7) as the primary efficacy endpoint).	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Achieved Disease Activity Control (UAS7 =< 6) at Week 12	The percentage of patients achieving disease activity control (UAS7 =< 6) at Week 12 was assessed to evaluate the efficacy of Remibrutinib in Chronic Spontaneous Urticaria (CSU) patients. The UAS7 is the sum of the Weekly Hives Severity Score (HSS7) and the Weekly Itch Severity Score (ISS7). The possible range of the UAS7 score is 0 - 42 (highest hives and itch severity).	Week 12
Number of Participants Who Achieved Complete Absence of Hives and Itch (UAS7 = 0) at Week 12	The proportion of patients achieving complete absence of hives and itch (UAS7 = 0) at Week 12 was assessed to evaluate the efficacy of Remibrutinib in Chronic Spontaneous Urticaria (CSU) patients. The UAS7 is the sum of the Weekly Hives Severity Score (HSS7) and the Weekly Itch Severity Score (ISS7). The possible range of the UAS7 score is 0 - 42 (highest hives and itch severity).	Week 12
Number of Participants Who Achieved Early Onset of Disease Activity Control (UAS7 =< 6) at Week 2	The percentage of patients achieving disease activity control (UAS7 =< 6) at Week 2 was assessed to evaluate the efficacy of Remibrutinib in Chronic Spontaneous Urticaria (CSU) patients. The UAS7 is the sum of the Weekly Hives Severity Score (HSS7) and the Weekly Itch Severity Score (ISS7). The possible range of the UAS7 score is 0 - 42 (highest hives and itch severity).	Week 2
Number of Participants Who Achieved Dermatology Life Quality Index (DLQI) = 0-1 at Week 12	The Dermatology Life Quality Index (DLQI) is a 10-item (grouped in 6 domains) dermatology-specific quality of life (QoL) measure. Participants are rating 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). Domain scores are calculated for: Symptoms and Feelings (0-6), Daily Activities (0-6), Leisure (0-6), Work and School (0-3), Personal Relationships (0-6), Treatment (0-3). The overall DLQI score range was split into score bands and validated in terms of their meaning/relevance to patients overall DLQI = 0-1 means no effect on patient's life.	Week 12
Mean Cumulative Number of Weeks With Disease Activity Control (UAS7 =< 6) up to Week 12	Maintaining disease activity control was assessed as cumulative number of weeks with an UAS7 =< 6 response between baseline and Week 12. The UAS7 is the sum of the Weekly Hives Severity Score (HSS7) and the Weekly Itch Severity Score (ISS7). The possible range of the UAS7 score is 0 - 42 (highest hives and itch severity).	Up to Week 12
Mean Cumulative Number of Angioedema Occurrence-free Weeks (AAS7 = 0 Response) up to Week 12	Angioedema occurrence was recorded once daily in the evening in the electronic Diary by the participant. Reporting the occurrence of angioedema was used as opening question for the assessment of the Angioedema Activity Score (AAS). The AAS consists of 5 questions with 4 answer options (scored 0-3) for each item, with a minimum score of 0 and a maximum score of 15 per day. The AAS score over 7 days (AAS7) ranges from 0 (no angioedema episodes) to 105 (highest angioedema severity).	Up to Week 12
Number of Participants With Treatment Emergent Adverse Events	An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. Treatment emergent Adverse Event (TEAEs) in this study are events that started after the first dose of study treatment and until 28 days after the last dose of study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 28 days after the last study treatment.	Baseline up to 28 days after last dose of study medication, assessed up to approximately 56 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• A Plain Language Trial Summary is available on www.novctrd.com

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): December 18, 2023
• Study Completion (Actual): January 5, 2024

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Bruton Tyrosine Kinase (BTK) inhibitor; Dermatology Life Quality Index (DLQI); Chronic Spontaneous Urticaria (CSU); Urticaria Activity Score (UAS); Weekly Urticaria Activity Score (UAS7); Hives Severity Score (HSS); Weekly Hives Severity Score (HSS7); Itch Severity Score (ISS); Weekly Itch Severity Score (ISS7); Angioedema Activity Score (AAS); Weekly Angioedema Activity Score (AAS7)
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Vascular; Chronic Urticaria; Urticaria; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Remibrutinib
• Other Study ID Numbers: CLOU064A2302; 2021-000424-35 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No