Generated static export from Obsidian-friendly vault markdown
ClinPharm Vault

Remibrutinib long-term extension and randomized-withdrawal CSU study (NCT05513001)

Study Snapshot

  • Program: Remibrutinib
  • Study ID(s): NCT05513001
  • Phase: Phase 3
  • Indication: Chronic Spontaneous Urticaria
  • Status: Active Not Recruiting
  • Sponsor: Novartis Pharmaceuticals
  • Study family: Lifecycle CSU extension program

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: RANDOMIZED
  • Intervention model: PARALLEL
  • Masking: QUADRUPLE
  • Primary purpose: TREATMENT
  • Enrollment: 696 (ACTUAL)

Population

  • Conditions: Chronic Spontaneous Urticaria
  • Sex: ALL
  • Age range: 18 Years to 100 Years
  • Healthy volunteers: False
  • Summary: The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 core studies.

This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.

Operational design summary

  • Arms represented in current CT.gov export: 3
  • Active dose regimens represented in current local source layer: 1
  • Total study enrollment in CT.gov: 696 (ACTUAL)
  • Per-arm sample size summary: 696 total with a 1:1 allocation schema across 3 listed arms; exact arm-specific counts are not explicitly stated in the current local source text.
  • Arm-size evidence source: ClinicalTrials.gov arm descriptions and summary text.

Arms

Arm Type Dose Frequency Route Description N Evidence status
Arm 1: LOU064 (blinded) EXPERIMENTAL NR NR Oral LOU064 (blinded) taken orally for 24 weeks, followed by cycles of either LOU064 (open-label) taken orally for a maximum of 5 cycles of 24 weeks each OR treatment-free observation cycles. Randomized in a 1:1 ratio (arm 1:arm 2) NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer
Arm 2: LOU064 Placebo (blinded) PLACEBO_COMPARATOR NR NR Oral LOU064 placebo (blinded) taken orally for 24 weeks, followed by cycles of either LOU064 (open-label) taken orally for a maximum of 5 cycles of 24 weeks each OR treatment-free observation cycles. Randomized in a 1:1 ratio (arm 1:arm 2) NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer
Arm 3: LOU064 (Open Label) EXPERIMENTAL NR NR Oral LOU064 (open-label) taken orally for 24 weeks per treatment cycle (Arm 3) NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer

Key source-backed points

  • CT.gov lists 696 actual participants and describes a randomized-withdrawal epoch followed by repeated open-label treatment cycles.
  • The primary endpoint is time to first composite relapse/discontinuation/confounding-medication event over 24 weeks.

Endpoints

  • Primary outcomes:
  • Time to first composite event (i.e., relapse (UAS7≥16) (time frame: 24 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/NCT05513001
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT05513001.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):
  • NCT05513001
  • ../raw/clinicaltrials/markdown/NCT05513001.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.