Trial Outcomes & Findings for A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines (NCT NCT05030311)

Last Updated: 2025-04-08

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

470 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2025-04-08

Participant Flow

The study was conducted globally across 18 countries. Participants underwent a screening period of up to 4 weeks.

Participant milestones

Participant milestones
Measure	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 Patients initially randomized to Placebo (Up to Week 24)
Overall Study STARTED	313	157
Overall Study Safety Set	309	153
Overall Study Full Analysis Set (FAS)	309	153
Overall Study COMPLETED	251	124
Overall Study NOT COMPLETED	62	33

Reasons for withdrawal

Reasons for withdrawal
Measure	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 Patients initially randomized to Placebo (Up to Week 24)
Overall Study Technical problems	0	1
Overall Study Withdrawal by Subject	31	17
Overall Study Adverse Event	13	5
Overall Study Unsatisfactory therapeutic effect	4	3
Overall Study Physician Decision	5	2
Overall Study Lost to Follow-up	5	1
Overall Study Protocol Violation	4	4

Baseline Characteristics

A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LOU064 25mg b.i.d. n=313 Participants 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 n=157 Participants Patients initially randomized to Placebo (Up to Week 24)	Total n=470 Participants Total of all reporting groups
Age, Continuous	44.6 Years STANDARD_DEVIATION 14.27 • n=93 Participants	45.9 Years STANDARD_DEVIATION 13.44 • n=4 Participants	45 Years STANDARD_DEVIATION 13.99 • n=27 Participants
Age, Customized >= 18 - < 65 years	282 Participants n=93 Participants	143 Participants n=4 Participants	425 Participants n=27 Participants
Age, Customized >= 65 - < 85 years	31 Participants n=93 Participants	14 Participants n=4 Participants	45 Participants n=27 Participants
Age, Customized >= 85 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	212 Participants n=93 Participants	109 Participants n=4 Participants	321 Participants n=27 Participants
Sex: Female, Male Male	101 Participants n=93 Participants	48 Participants n=4 Participants	149 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	76 Participants n=93 Participants	44 Participants n=4 Participants	120 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	237 Participants n=93 Participants	113 Participants n=4 Participants	350 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	12 Participants n=93 Participants	14 Participants n=4 Participants	26 Participants n=27 Participants
Race (NIH/OMB) Asian	94 Participants n=93 Participants	46 Participants n=4 Participants	140 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	12 Participants n=93 Participants	3 Participants n=4 Participants	15 Participants n=27 Participants
Race (NIH/OMB) White	188 Participants n=93 Participants	89 Participants n=4 Participants	277 Participants n=27 Participants
Race (NIH/OMB) More than one race	6 Participants n=93 Participants	2 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set (FAS)

Outcome measures

Outcome measures
Measure	LOU064 25mg b.i.d. n=309 Participants 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 n=153 Participants Patients initially randomized to Placebo (Up to Week 24)	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)	Open-label Period: Transitioned to LOU064 25 mg 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)
Change From Baseline in Weekly Urticaria Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint)	-20.02 Scores on a scale Standard Error 0.716	-13.79 Scores on a scale Standard Error 0.980	—	—

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set (FAS)

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).

Outcome measures

Outcome measures
Measure	LOU064 25mg b.i.d. n=309 Participants 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 n=153 Participants Patients initially randomized to Placebo (Up to Week 24)	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)	Open-label Period: Transitioned to LOU064 25 mg 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)
Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints)	-9.52 Scores on a scale Standard Error 0.343	-6.89 Scores on a scale Standard Error 0.470	—	—

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set (FAS)

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.

Outcome measures

Outcome measures
Measure	LOU064 25mg b.i.d. n=309 Participants 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 n=153 Participants Patients initially randomized to Placebo (Up to Week 24)	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)	Open-label Period: Transitioned to LOU064 25 mg 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)
Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints)	-10.47 Scores on a scale Standard Error 0.401	-6.86 Scores on a scale Standard Error 0.548	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set (FAS)

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).

Outcome measures

Outcome measures
Measure	LOU064 25mg b.i.d. n=309 Participants 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 n=153 Participants Patients initially randomized to Placebo (Up to Week 24)	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)	Open-label Period: Transitioned to LOU064 25 mg 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)
Number of Patients Who Achieved Disease Activity Control (UAS7 ≤6)	154 Participants	38 Participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set (FAS)

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).

Outcome measures

Outcome measures
Measure	LOU064 25mg b.i.d. n=309 Participants 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 n=153 Participants Patients initially randomized to Placebo (Up to Week 24)	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)	Open-label Period: Transitioned to LOU064 25 mg 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)
Number of Patients Who Achieved Complete Absence of Hives and Itch (UAS7 = 0)	96 Participants	16 Participants	—	—

SECONDARY outcome

Timeframe: Week 2

Population: Full Analysis Set (FAS)

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).

Outcome measures

Outcome measures
Measure	LOU064 25mg b.i.d. n=309 Participants 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 n=153 Participants Patients initially randomized to Placebo (Up to Week 24)	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)	Open-label Period: Transitioned to LOU064 25 mg 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)
Number of Patients With Early Onset of Disease Control (UAS7 ≤ 6 at Week 2)	104 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: up to Week 12

Population: Full Analysis Set (FAS)

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).

Outcome measures

Outcome measures
Measure	LOU064 25mg b.i.d. n=309 Participants 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 n=153 Participants Patients initially randomized to Placebo (Up to Week 24)	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)	Open-label Period: Transitioned to LOU064 25 mg 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)
Cumulative Number of Weeks With Disease Activity Control (UAS7 <= 6) up to Week 12	5.17 weeks Standard Error 0.414	1.92 weeks Standard Error 0.241	—	—

SECONDARY outcome

Timeframe: Week 12

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

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.

Outcome measures

Outcome measures
Measure	LOU064 25mg b.i.d. n=308 Participants 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 n=153 Participants Patients initially randomized to Placebo (Up to Week 24)	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)	Open-label Period: Transitioned to LOU064 25 mg 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)
Number of Patients Who Achieved DLQI = 0 - 1	120 Participants	34 Participants	—	—

SECONDARY outcome

Timeframe: Up to Week 12

Population: Full Analysis Set (FAS)

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).

Outcome measures

Outcome measures
Measure	LOU064 25mg b.i.d. n=309 Participants 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 n=153 Participants Patients initially randomized to Placebo (Up to Week 24)	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)	Open-label Period: Transitioned to LOU064 25 mg 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)
Cumulative Number of Weeks Without Angioedema (AAS7 = 0)	8.43 Weeks Standard Error 0.274	6.72 Weeks Standard Error 0.330	—	—

SECONDARY outcome

Timeframe: 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

Population: Safety Set (SAF)

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.

Outcome measures

Outcome measures
Measure	LOU064 25mg b.i.d. n=309 Participants 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 n=153 Participants Patients initially randomized to Placebo (Up to Week 24)	Entire Study Period: LOU064 25mg b.i.d. n=309 Participants Patients initially randomized to Remibrutinib during the Double-blind treatment period and continued Remibrutinib during the Open-label treatment period (Up to Week 52)	Open-label Period: Transitioned to LOU064 25 mg b.i.d. n=133 Participants Patients initially randomized to placebo during the Double-blind treatment period and switched to Remibrutinib during the Open-label treatment period (Weeks 25-52)
Number of Participants With Adverse Events Patients with serious or other significant events - Treatment interruption due to AEs	17 Participants	9 Participants	18 Participants	3 Participants
Number of Participants With Adverse Events Patients with at least one AE	188 Participants	86 Participants	218 Participants	62 Participants
Number of Participants With Adverse Events Patients with serious or other significant events - Death	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Patients with serious or other significant events - SAEs	10 Participants	1 Participants	13 Participants	1 Participants
Number of Participants With Adverse Events Discontinued study treatment due to any AEs	11 Participants	3 Participants	15 Participants	2 Participants
Number of Participants With Adverse Events Patients with serious or other significant events - Discontinued study treatment due to any SAEs	2 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With Adverse Events Patients with serious or other significant events - Treatment interruption due to SAEs	5 Participants	1 Participants	5 Participants	0 Participants

Adverse Events

LOU064 25mg b.i.d.

Serious events: 13 serious events

Other events: 139 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 53 other events

Deaths: 0 deaths

Transitioned to LOU064 25mg b.i.d.

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	LOU064 25mg b.i.d. n=309 participants at risk 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 n=153 participants at risk Patients initially randomized to Placebo (Up to Week 24)	Transitioned to LOU064 25mg b.i.d. n=133 participants at risk Patients initially randomized to placebo during the Double-blind treatment period and switched to Remibrutinib during the Open-label treatment period (Weeks 25-52)
Skin and subcutaneous tissue disorders Urticaria	3.6% 11/309 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	5.2% 8/153 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	1.5% 2/133 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	3.6% 11/309 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.6% 7/153 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	1.5% 2/133 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Gastrointestinal disorders Nausea	3.6% 11/309 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.0% 3/153 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/133 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
General disorders Pyrexia	3.2% 10/309 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.0% 3/153 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.75% 1/133 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations COVID-19	10.0% 31/309 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	9.2% 14/153 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.5% 6/133 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Influenza	3.2% 10/309 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	1.3% 2/153 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.0% 4/133 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Nasopharyngitis	7.1% 22/309 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.3% 5/153 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	4.5% 6/133 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Upper respiratory tract infection	3.9% 12/309 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	1.3% 2/153 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.3% 3/133 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Infections and infestations Urinary tract infection	5.5% 17/309 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.6% 4/153 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.75% 1/133 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	2.9% 9/309 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.3% 5/153 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	1.5% 2/133 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Nervous system disorders Headache	8.1% 25/309 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	7.2% 11/153 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	2.3% 3/133 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	3.9% 12/309 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	1.3% 2/153 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/133 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Petechiae	3.6% 11/309 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.65% 1/153 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	1.5% 2/133 • 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 Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER