Remibrutinib ambulatory blood pressure monitoring Phase 3 study (NCT05795153)

Study Snapshot

• Program: Remibrutinib
• Study ID(s): NCT05795153
• Phase: Phase 3
• Indication: Chronic Spontaneous Urticaria
• Status: Completed
• Sponsor: Novartis Pharmaceuticals
• Study family: Focused safety characterization

Design

• Study type: INTERVENTIONAL
• Randomization / allocation: NA
• Intervention model: SINGLE_GROUP
• Masking: NONE
• Primary purpose: TREATMENT
• Enrollment: 144 (ACTUAL)

Population

• Conditions: Chronic Spontaneous Urticaria
• Sex: ALL
• Age range: 18 Years to 99 Years
• Healthy volunteers: False
• Summary: 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)).

Operational design summary

• Arms represented in current CT.gov export: 1
• Active dose regimens represented in current local source layer: 1
• Total study enrollment in CT.gov: 144 (ACTUAL)
• Per-arm sample size summary: LOU064 (remibrutinib) n=144
• Arm-size evidence source: ClinicalTrials.gov arm descriptions and summary text.

Arms

Key source-backed points

• CT.gov lists 144 actual participants in this 12-week ABPM study.
• The primary endpoint is estimated mean change in 24-hour systolic blood pressure at week 4 by ambulatory blood pressure monitoring.

Endpoints

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

Clinical Pharmacology Findings

• PK: Not clearly summarized in the currently linked local source snippets.
• PD: Not clearly summarized in the currently linked local source snippets.
• Linked manuscripts: No trial-level primary publication is explicitly linked in the current registry.

Safety Findings

• Safety detail is not strongly enriched beyond the current CT.gov/source-registry layer.

Linked Evidence

• CT.gov page: https://clinicaltrials.gov/study/NCT05795153
• Local CT.gov cache: raw/clinicaltrials/markdown/NCT05795153.md

Interpretation

• Verified facts: this page reflects the current local registry and CT.gov inventory export without inferring unsupported arm sizes or endpoint results.
• Interpretation: this trial is currently represented mainly by CT.gov and any linked sponsor-source artifacts; manual enrichment is still needed for a richer narrative page.
• Open questions:
• Some studies still lack exact arm-specific N in the current promoted evidence layer even when allocation schema or total enrollment is visible.
• No explicit trial-level primary manuscript is currently linked in the registry.
• No sponsor artifact is explicitly linked to this trial by identifier in the current registry.

Provenance

• Source type: ClinicalTrials.gov inventory with linked sponsor/publication registry where available
• Primary source(s):
• NCT05795153
• ../raw/clinicaltrials/markdown/NCT05795153.md
• ../inventories/source_registry.json
• Supporting source(s):
• ../inventories/ctgov_priority_trials.json
• Last verified: 2026-04-08
• Verification status: Partial

Change Log

• 2026-04-08: Generated or refreshed this study page from the v2 source registry and CT.gov inventory.