Trial Outcomes & Findings for A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks. (NCT NCT05795153)

Last Updated: 2025-10-16

Results Overview

A linear regression with SBP as a covariate was employed. The change in SBP from baseline to Week 4 was predicted at the median baseline level. The change from baseline in the 24-hour weighted average SBP was calculated using the time weighted average of the area under the curve (AUC) of SBP obtained over a 24-hour period as measured by ABPM. That is, the time weighted average of AUC of 24-hour SBP obtained at baseline was subtracted from corresponding time weighted average of AUC of SBP at Week 4. In the analysis, if participants took prohibited antihypertensive treatment before Week 4, their subsequent measurements were excluded. In such cases, the excluded measurements were imputed by increasing the 24-hour SBP by 3 mmHg from the baseline value at Week 4. Moreover, participants who discontinued of study treatment due to any reason prior to the Week 4 were excluded from the analysis. The Mixed Models for Repeated Measures (MMRM) approach was used.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

144 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2025-10-16

Participant Flow

This study was conducted globally across 10 countries: Argentina (4 centers), Canada (2 centers), France (8 centers), Germany (6 centers), Republic of Korea (3 centers), Singapore (1 center), Slovakia (3 centers), Spain (4 centers), Turkey (3 centers), and USA (11 centers).

Participants underwent a screening period of up to 4 weeks.

Participant milestones

Participant milestones
Measure	LOU064 (Remibrutinib) All participants were assigned to remibrutinib 25 mg b.i.d. for 12 weeks.
Overall Study STARTED	144
Overall Study COMPLETED	137
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	LOU064 (Remibrutinib) All participants were assigned to remibrutinib 25 mg b.i.d. for 12 weeks.
Overall Study Adverse Event	2
Overall Study Unsatisfactory therapeutic effect	2
Overall Study Lost to Follow-up	1
Overall Study Subject decision	2

Baseline Characteristics

A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LOU064 (Remibrutinib) n=144 Participants All participants were assigned to remibrutinib 25 mg b.i.d. for 12 weeks.
Age, Continuous	42.2 Years STANDARD_DEVIATION 14.52 • n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	19 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	89 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	32 Participants n=5 Participants
Baseline Systolic Blood Pressure (SBP)	117.1 millimeter of mercury (mmHg) STANDARD_DEVIATION 13.11 • n=5 Participants
Baseline Diastolic Blood Pressure (DBP)	75.0 millimeter of mercury (mmHg) STANDARD_DEVIATION 8.98 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: Full Analysis Set (FAS): all participants to whom study treatment was assigned and received at least one dose of treatment. Participants who discontinued treatment prior to Week 4 were excluded from the analysis.

Outcome measures

Outcome measures
Measure	LOU064 (Remibrutinib) n=143 Participants All participants were assigned to remibrutinib 25 mg b.i.d. for 12 weeks.
Estimated Mean Change From Baseline at Week 4 in 24-hour Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM)	-1.3 millimeter of mercury (mmHg) Interval -2.3 to -0.3

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Full Analysis Set (FAS): all participants to whom study treatment was assigned and received at least one dose of treatment. Only participants with a value at both baseline and Week 4 were included.

The change from baseline in the 24-hour weighted average systolic blood pressure (SBP) was calculated using the time weighted average of the area under the curve (AUC) of SBP obtained over a 24-hour period as measured by ABPM. This analysis was conducted using the observed data. Data was computed taking weighted averages over time and discarding time intervals of more than 1 hour without measurements.

Outcome measures

Outcome measures
Measure	LOU064 (Remibrutinib) n=142 Participants All participants were assigned to remibrutinib 25 mg b.i.d. for 12 weeks.
Observed Mean Change From Baseline to Week 4 in 24-hour Weighted Average Systolic Blood Pressure (SBP) Measured by ABPM	-1.65 millimeter of mercury (mmHg) Standard Deviation 6.905

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: FAS: all participants to whom study treatment was assigned and received at least one dose of treatment. Participants who discontinued treatment prior to Week 4 were excluded from the analysis.

A linear regression with DBP as a covariate was employed. The change in DBP from baseline to Week 4 was predicted at the median baseline level. The change from baseline in the 24-hour weighted average DBP was calculated using the time weighted average of the area under the curve (AUC) of DBP obtained over a 24-hour period as measured by ABPM. That is, the time weighted average of AUC of 24-hour DBP obtained at baseline was subtracted from corresponding time weighted average of AUC of DBP at Week 4. In the analysis, if participants took prohibited antihypertensive treatment before Week 4, their subsequent measurements were excluded. In such cases, the excluded measurements were imputed by increasing the 24-hour DBP by 3 mmHg from the baseline value at Week 4. Moreover, participants who discontinued of study treatment due to any reason prior to the Week 4 were excluded from the analysis. The Mixed Models for Repeated Measures (MMRM) approach was used.

Outcome measures

Outcome measures
Measure	LOU064 (Remibrutinib) n=143 Participants All participants were assigned to remibrutinib 25 mg b.i.d. for 12 weeks.
Estimated Mean Change From Baseline at Week 4 in 24-hour Diastolic Blood Pressure (DBP) Measured by ABPM	-0.1 millimeter of mercury (mmHg) Interval -0.8 to 0.6

SECONDARY outcome

Timeframe: Baseline, Week 4

The change in daytime (respectively nighttime) weighted average SBP was analyzed using linear regression model with baseline weighted average daytime SBP (respectively nighttime) as a covariate. The change in daytime (respectively nighttime) SBP from baseline to Week 4 was predicted at the median baseline level. The change from baseline of daytime (respectively nighttime) SBP was calculated using the time weighted average of the AUC of DBP obtained over daytime (respectively nighttime) In the analysis, if participants took prohibited antihypertensive treatment before Week 4, their subsequent measurements were excluded. In such cases, the excluded measurements were imputed by increasing the 24-hour SBP by 3 mmHg from the baseline value at Week 4. Moreover, participants who discontinued of study treatment due to any reason prior to the Week 4 were excluded from the analysis. The multiple imputation approach was used. Daytime: from 7am until 10 pm. Nighttime: from 10pm until 7 am.

Outcome measures

Outcome measures
Measure	LOU064 (Remibrutinib) n=143 Participants All participants were assigned to remibrutinib 25 mg b.i.d. for 12 weeks.
Estimated Mean Change From Baseline at Week 4 in Daytime and Nighttime Average SBP Measured by ABPM daytime average SBP	-1.2 millimeter of mercury (mmHg) Interval -2.3 to 0.0
Estimated Mean Change From Baseline at Week 4 in Daytime and Nighttime Average SBP Measured by ABPM nighttime average SBP	-0.9 millimeter of mercury (mmHg) Interval -2.2 to 0.5

SECONDARY outcome

Timeframe: Baseline, Week 4

The change in daytime (respectively nighttime) weighted average DBP was analyzed using linear regression model with baseline weighted average daytime DBP (respectively nighttime) as a covariate. The change in daytime (respectively nighttime) DBP from baseline to Week 4 was predicted at the median baseline level. The change from baseline of daytime (respectively nighttime) DBP was calculated using the time weighted average of the AUC of DBP obtained over daytime (respectively nighttime) In the analysis, if participants took prohibited antihypertensive treatment before Week 4, their subsequent measurements were excluded. In such cases, the excluded measurements were imputed by increasing the 24-hour DBP by 3 mmHg from the baseline value at Week 4. Moreover, participants who discontinued of study treatment due to any reason prior to the Week 4 were excluded from the analysis. The multiple imputation approach was used. Daytime: from 7am until 10 pm. Nighttime: from 10pm until 7 am.

Outcome measures

Outcome measures
Measure	LOU064 (Remibrutinib) n=143 Participants All participants were assigned to remibrutinib 25 mg b.i.d. for 12 weeks.
Estimated Mean Change From Baseline at Week 4 in Daytime and Nighttime Average DBP Measured by ABPM daytime average DBP	-0.6 millimeter of mercury (mmHg) Interval -1.3 to 0.2
Estimated Mean Change From Baseline at Week 4 in Daytime and Nighttime Average DBP Measured by ABPM nighttime average DBP	0.2 millimeter of mercury (mmHg) Interval -0.8 to 1.1

Adverse Events

LOU064 (Remibrutinib)

Serious events: 4 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LOU064 (Remibrutinib) n=144 participants at risk All participants were assigned to remibrutinib 25 mg b.i.d. for 12 weeks
Hepatobiliary disorders Cholecystitis acute	0.69% 1/144 • On-treatment adverse events and deaths were reported from first dose of study medication up to 28 days after last dose of study medication, assessed up to approximately 18 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 enrolled subjects who received at least one dose of study medication.
Nervous system disorders Dizziness	0.69% 1/144 • On-treatment adverse events and deaths were reported from first dose of study medication up to 28 days after last dose of study medication, assessed up to approximately 18 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 enrolled subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Chronic spontaneous urticaria	0.69% 1/144 • On-treatment adverse events and deaths were reported from first dose of study medication up to 28 days after last dose of study medication, assessed up to approximately 18 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 enrolled subjects who received at least one dose of study medication.
Vascular disorders Aortic dissection	0.69% 1/144 • On-treatment adverse events and deaths were reported from first dose of study medication up to 28 days after last dose of study medication, assessed up to approximately 18 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 enrolled subjects who received at least one dose of study medication.

Other adverse events

Other adverse events
Measure	LOU064 (Remibrutinib) n=144 participants at risk All participants were assigned to remibrutinib 25 mg b.i.d. for 12 weeks
Infections and infestations Nasopharyngitis	8.3% 12/144 • On-treatment adverse events and deaths were reported from first dose of study medication up to 28 days after last dose of study medication, assessed up to approximately 18 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 enrolled subjects who received at least one dose of study medication.
Nervous system disorders Headache	9.0% 13/144 • On-treatment adverse events and deaths were reported from first dose of study medication up to 28 days after last dose of study medication, assessed up to approximately 18 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 enrolled subjects who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Chronic spontaneous urticaria	5.6% 8/144 • On-treatment adverse events and deaths were reported from first dose of study medication up to 28 days after last dose of study medication, assessed up to approximately 18 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 enrolled 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