NCT05795153

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.

Completed Phase 3 Results posted Last updated 16 October 2025

What this trial tests

Phase 3 trial testing LOU064 in Chronic Spontaneous Urticaria in 144 participants. Completed in 25 April 2024.

Timeline

5 April 2023

Primary endpoint
25 April 2024

25 April 2024

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	144
Start date	5 April 2023
Primary completion	25 April 2024
Estimated completion	25 April 2024
Sites	44 locations across France, Slovakia, Germany, South Korea, Argentina, Canada, Singapore, United States

Drugs / interventions tested

• LOU064 — full drug profile →

Conditions studied

• Chronic Spontaneous Urticaria — all drugs for Chronic Spontaneous Urticaria →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 99, any sex, with Chronic Spontaneous Urticaria. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Estimated Mean Change From Baseline at Week 4 in 24-hour Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM) Primary · Baseline, Week 4

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, thei

Group	Value	95% CI
LOU064 (Remibrutinib)	-1.3	-2.3 – -0.3

Observed Mean Change From Baseline to Week 4 in 24-hour Weighted Average Systolic Blood Pressure (SBP) Measured by ABPM Secondary · Baseline, Week 4

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.

Group	Value	95% CI
LOU064 (Remibrutinib)	-1.65	± 6.905

Estimated Mean Change From Baseline at Week 4 in 24-hour Diastolic Blood Pressure (DBP) Measured by ABPM Secondary · Baseline, Week 4

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, thei

Group	Value	95% CI
LOU064 (Remibrutinib)	-0.1	-0.8 – 0.6

Estimated Mean Change From Baseline at Week 4 in Daytime and Nighttime Average SBP Measured by ABPM Secondary · 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 m

daytime average SBP

Group	Value	95% CI
LOU064 (Remibrutinib)	-1.2	-2.3 – -0.0

nighttime average SBP

Group	Value	95% CI
LOU064 (Remibrutinib)	-0.9	-2.2 – 0.5

Estimated Mean Change From Baseline at Week 4 in Daytime and Nighttime Average DBP Measured by ABPM Secondary · 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 m

daytime average DBP

Group	Value	95% CI
LOU064 (Remibrutinib)	-0.6	-1.3 – 0.2

nighttime average DBP

Group	Value	95% CI
LOU064 (Remibrutinib)	0.2	-0.8 – 1.1

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

LOU064 (Remibrutinib)

Serious: 4/144 (3%)

Deaths: 0/144

Serious adverse events (4 terms)

Reaction	System	LOU064 (Remibrutinib)
Cholecystitis acute	Hepatobiliary disorders	—
Dizziness	Nervous system disorders	—
Chronic spontaneous urticaria	Skin and subcutaneous tissue disorders	—
Aortic dissection	Vascular disorders	—

Other adverse events (3 terms — click to expand)

Reaction	System	LOU064 (Remibrutinib)
Headache	Nervous system disorders	—
Nasopharyngitis	Infections and infestations	—
Chronic spontaneous urticaria	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Cholecystitis acute, Dizziness, Chronic spontaneous urticaria, Aortic dissection.

Data from ClinicalTrials.gov NCT05795153 adverse events section.

Sponsor's own description

The purpose of this study was to assess the effect of remibrutinib 25 mg twice a day (b.i.d.) open-label on Systolic Blood Pressure (SBP) measured as a change in 24-hour weighted average SBP from baseline to Week 4 assessed by Ambulator Blood Pressure Monitoring (ABPM); and to assess overall safety and efficacy over 12 weeks in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled with second generation H1 antihistamines (H1-AH) treatment. ABPM was chosen for the blood pressure assessment in this trial as recommended by the FDA for drugs intended for chronic use (Assessment of Pressor Effects of Drugs Guidance for Industry (FDA 2022)).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Update on the Treatment of Chronic Spontaneous Urticaria.
   Kolkhir P, Fok JS, Kocatürk E, Li PH, et al · · 2025 · cited 12× · PMID 40074986 · DOI 10.1007/s40265-025-02170-4