Generated static export from Obsidian-friendly vault markdown
ClinPharm Vault

Remibrutinib Japanese open-label Phase 3 CSU study (NCT05048342)

Study Snapshot

  • Program: Remibrutinib
  • Study ID(s): NCT05048342
  • Phase: Phase 3
  • Indication: Chronic Spontaneous Urticaria
  • Status: Completed
  • Sponsor: Novartis Pharmaceuticals
  • Study family: Regional CSU expansion

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: NA
  • Intervention model: SINGLE_GROUP
  • Masking: NONE
  • Primary purpose: TREATMENT
  • Enrollment: 71 (ACTUAL)

Population

  • Conditions: Chronic Spontaneous Urticaria
  • Sex: ALL
  • Age range: 18 Years to 100 Years
  • Healthy volunteers: False
  • Summary: The purpose of this study was to evaluate the safety, tolerability and efficacy of remibrutinib (LOU064) in adult Japanese patients chronic spontaneous urticaria (CSU), who remain symptomatic despite treatment by H1-antihistamine (H1-AH) at locally label approved doses, for a duration of 52 weeks of treatment with remibrutinib and a post-treatment follow-up period of up to 4 weeks.

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: 71 (ACTUAL)
  • Per-arm sample size summary: LOU064 25 mg b.i.d. n=71
  • Arm-size evidence source: ClinicalTrials.gov arm descriptions and summary text.

Arms

Arm Type Dose Frequency Route Description N Evidence status
LOU064 25 mg b.i.d. EXPERIMENTAL 25 mg BID Oral Patients were treated with remibrutinib 25 mg bis in die/twice a day (b.i.d.). LOU064 open-label treatment taken orally for 52 weeks. 71 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context

Key source-backed points

  • CT.gov lists 71 actual participants in this adult Japanese CSU study.
  • The trial is open-label and evaluates remibrutinib 25 mg twice daily over 52 weeks.

Endpoints

  • Primary outcomes:
  • Number of Participants With Treatment Emergent Adverse Events (time frame: Baseline up to 30 days after last dose of study medication, assessed up to approximately 56 weeks)

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/NCT05048342
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT05048342.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):
  • NCT05048342
  • ../raw/clinicaltrials/markdown/NCT05048342.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.