A Phase 3 Study of Efficacy and Safety of Remibrutinib in... | NCT05030311

NCT05030311

ID	Type	Description	Link
2022-001034-11	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LOU064 25mg b.i.d.	Experimental	Patients initially randomized to Remibrutinib during the Double-blind treatment period and continued Remibrutinib during the Open-label treatment period (Up to Week 52)	Drug: LOU064 25 mg (b.i.d) Drug: LOU064 25 mg (b.i.d) as a tablet.
Placebo	Placebo Comparator	Patients initially randomized to Placebo (Up to Week 24)	Drug: Placebo Drug: LOU064 25 mg (b.i.d) as a tablet.

Name	Type	Description	Arm Group Labels	Other Names
LOU064 25 mg (b.i.d)	Drug	LOU064 25 mg was administered by oral route twice a day (b.i.d) as a tablet.	LOU064 25mg b.i.d.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Weekly Urticaria 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
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
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 Outcomes

Measure	Description	Time Frame
Number of Patients Who Achieved Disease Activity Control (UAS7 ≤6)	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).

Eligibility Module

Eligibility Criteria

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).

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

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Birmingham	Alabama	35209	United States
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
42297099	Derived	Mosnaim G, Saini S, Lebwohl M, Thomsen SF, Reed J, Yang B, Fukunaga A, Jain V, Field C, Kuruvilla M, Martzloff ED, Seko N, Wang P, Haemmerle S, Metz M. Remibrutinib impact on disease control, sleep, and quality of life: Analysis of phase 3 REMIX-1/2. Ann Allergy Asthma Immunol. 2026 Jun 15:S1081-1206(26)00271-1. doi: 10.1016/j.anai.2026.06.011. Online ahead of print.
40043237

Label	URL
A Plain Language Trial Summary is available on www.novctrd.com	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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)
FG001	Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 23, 2022	Oct 18, 2024

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00044.6± 14.27 BG00145.9± 13.44 BG00245± 13.99

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
>= 18 - < 65 years	BG000282 BG001143 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000212 BG001109 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00076 BG00144 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG00012 BG00114 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Weekly Urticaria 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).

Full Analysis Set (FAS)

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline, Week 12

ID	Title	Description
OG000	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)
OG001	Placebo	Patients initially randomized to Placebo (Up to Week 24)

Units	Counts
Participants	OG000309 OG001153

Title

Denominators

Categories

Title	Measurements
	OG000-20.02± 0.716 OG001-13.79± 0.980

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis		<0.001		Mean Difference (Final Values)	-6.22	Standard Error of the Mean	1.136	2-Sided	95	-8.45	-4.00			MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, visit week, baseline score and both interaction of treatment by visit week and interaction of baseline score by visit week.		Superiority

Primary

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).

Full Analysis Set (FAS)

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline, Week 12

ID	Title	Description
OG000	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)
OG001	Placebo	Patients initially randomized to Placebo (Up to Week 24)

Units	Counts
Participants

Primary

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.

Full Analysis Set (FAS)

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline, Week 12

ID	Title	Description
OG000	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)
OG001	Placebo	Patients initially randomized to Placebo (Up to Week 24)

Units	Counts
Participants

Secondary

Number of Patients Who Achieved Disease Activity Control (UAS7 ≤6)

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).

Full Analysis Set (FAS)

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	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)
OG001	Placebo	Patients initially randomized to Placebo (Up to Week 24)

Units	Counts
Participants	OG000

Secondary

Number of Patients Who Achieved Complete Absence of Hives and Itch (UAS7 = 0)

The number 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).

Full Analysis Set (FAS)

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	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)
OG001	Placebo	Patients initially randomized to Placebo (Up to Week 24)

Units	Counts
Participants	OG000

Secondary

Number of Patients With Early Onset of Disease 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).

Full Analysis Set (FAS)

Posted

Count of Participants

Participants

Week 2

ID	Title	Description
OG000	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)
OG001	Placebo	Patients initially randomized to Placebo (Up to Week 24)

Units	Counts
Participants	OG000

Secondary

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).

Full Analysis Set (FAS)

Posted

Least Squares Mean

Standard Error

weeks

up to Week 12

ID	Title	Description
OG000	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)
OG001	Placebo	Patients initially randomized to Placebo (Up to Week 24)

Units	Counts
Participants	OG000

Secondary

Number of Patients Who Achieved DLQI = 0 - 1

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.

Full Analysis Set (FAS) - for patients with a valid measurement without a protocol deviation with impact.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	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)
OG001	Placebo	Patients initially randomized to Placebo (Up to Week 24)

Secondary

Cumulative Number of Weeks Without Angioedema (AAS7 = 0)

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).

Full Analysis Set (FAS)

Posted

Least Squares Mean

Standard Error

Weeks

Up to Week 12

ID	Title	Description
OG000	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)
OG001	Placebo	Patients initially randomized to Placebo (Up to Week 24)

Units	Counts
Participants

Secondary

Number of Participants With 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.

Safety Set (SAF)

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Double-blind Treatment Period: LOU064 25 mg b.i.d.	Patients initially randomized to Remibrutinib (Up to Week 24)
OG001	Double-blind Treatment Period: Placebo	Patients initially randomized to Placebo (Up to Week 24)
OG002	Entire Study Period: 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)

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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)	309	13	309	139	309
EG001	Placebo	Patients initially randomized to Placebo (Up to Week 24)	153	1	153	53	153
EG002	Transitioned to LOU064 25mg b.i.d.	Patients initially randomized to placebo during the Double-blind treatment period and switched to Remibrutinib during the Open-label treatment period (Weeks 25-52)	133	1	133	26	133

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected309 at risk EG0010 affected153 at risk EG0020 affected133 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected309 at risk EG0010 affected153 at risk EG0020 affected133 at risk
Gastrointestinal wall thickening	Gastrointestinal disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected309 at risk EG0010 affected153 at risk EG0020 affected133 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (26.1)	Systematic Assessment	EG0000 affected309 at risk EG0011 affected153 at risk EG0020 affected133 at risk
Appendicitis	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG0001 affected309 at risk EG0010 affected153 at risk EG0020 affected133 at risk
COVID-19	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG0001 affected309 at risk EG0010 affected153 at risk EG0020 affected133 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA (26.1)	Systematic Assessment	EG0001 affected309 at risk EG0010 affected153 at risk EG0020 affected133 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected309 at risk EG0010 affected153 at risk EG0020 affected133 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected309 at risk EG0010 affected153 at risk EG0020 affected133 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected309 at risk EG0010 affected153 at risk EG0020 affected133 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected309 at risk EG0010 affected153 at risk EG0020 affected133 at risk
Benign renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Systematic Assessment	EG0001 affected309 at risk EG0010 affected153 at risk EG0020 affected133 at risk
Mucinous adenocarcinoma of appendix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Systematic Assessment	EG0001 affected309 at risk EG0010 affected153 at risk EG0020 affected133 at risk
Small intestine adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Systematic Assessment	EG0001 affected309 at risk EG0010 affected153 at risk EG0020 affected133 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (26.1)	Systematic Assessment	EG0000 affected309 at risk EG0010 affected153 at risk EG0021 affected133 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected309 at risk EG0010 affected153 at risk EG0020 affected133 at risk
Chronic spontaneous urticaria	Skin and subcutaneous tissue disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected309 at risk EG0010 affected153 at risk EG0020 affected133 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (26.1)	Systematic Assessment	EG00011 affected309 at risk EG0017 affected153 at risk EG0022 affected133 at risk
Nausea	Gastrointestinal disorders	MedDRA (26.1)	Systematic Assessment	EG00011 affected309 at risk EG0013 affected153 at risk EG0020 affected133 at risk
Pyrexia	General disorders	MedDRA (26.1)	Systematic Assessment	EG00010 affected309 at risk EG0013 affected153 at risk EG0021 affected133 at risk
COVID-19	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG00031 affected309 at risk EG00114 affected153 at risk EG0026 affected133 at risk
Influenza	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG00010 affected309 at risk EG0012 affected153 at risk EG0024 affected133 at risk
Nasopharyngitis	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG00022 affected309 at risk EG0015 affected153 at risk EG0026 affected133 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG00012 affected309 at risk EG0012 affected153 at risk EG0023 affected133 at risk
Urinary tract infection	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG00017 affected309 at risk EG0014 affected153 at risk EG0021 affected133 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Systematic Assessment	EG0009 affected309 at risk EG0015 affected153 at risk EG0022 affected133 at risk
Headache	Nervous system disorders	MedDRA (26.1)	Systematic Assessment	EG00025 affected309 at risk EG00111 affected153 at risk EG0023 affected133 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (26.1)	Systematic Assessment	EG00012 affected309 at risk EG0012 affected153 at risk EG0020 affected133 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (26.1)	Systematic Assessment	EG00011 affected309 at risk EG0011 affected153 at risk EG0022 affected133 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (26.1)	Systematic Assessment	EG00011 affected309 at risk EG0018 affected153 at risk EG0022 affected133 at risk

ID	Term
D014581	Urticaria
D017445	Skin Diseases, Vascular
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	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)
BG001	Placebo	Patients initially randomized to Placebo (Up to Week 24)
BG002	Total	Total of all reporting groups