Generated static export from Obsidian-friendly vault markdown
ClinPharm Vault

Remibrutinib CSU phase 2 open-label extension (NCT04109313)

Study Snapshot

  • Program: Remibrutinib
  • Study ID(s): NCT04109313
  • Phase: Phase 2
  • Indication: Chronic Spontaneous Urticaria
  • Status: Completed
  • Sponsor: Novartis Pharmaceuticals
  • Study family: Foundational CSU extension program

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: NA
  • Intervention model: SINGLE_GROUP
  • Masking: NONE
  • Primary purpose: TREATMENT
  • Enrollment: 229 (ACTUAL)

Population

  • Conditions: Chronic Spontaneous Urticaria
  • Sex: ALL
  • Age range: 18 Years to 99 Years
  • Healthy volunteers: False
  • Summary: The main objective to assess the long-term safety and tolerability of LOU064 in patients with chronic spontaneous urticaria (CSU) who have participated in study CLOU064A2201 (NCT03926611)

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: 229 (ACTUAL)
  • Per-arm sample size summary: All participants n=229
  • Arm-size evidence source: ClinicalTrials.gov arm descriptions and summary text.

Arms

Arm Type Dose Frequency Route Description N Evidence status
All participants EXPERIMENTAL 100 mg BID NR Participants with UAS7\<16 at Week 16 of CLOU064A2201 were followed up to 12 weeks without receiving treatment (observational period). If participants relapsed (UAS7≥16 at least once), they were transitioned to the treatment period. Otherwise, they were discontinued from the study. Participants with a UAS7≥16 at Week 12 or Week 16 in the CLOU064A2201, as well as participants who experienced a relapse during the 12-week observational period, were administered 100 mg of LOU064 b.i.d. open-label for up to 52 weeks. 229 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context

Key source-backed points

  • CT.gov describes this as an open-label multicenter extension for eligible participants from CLOU064A2201.
  • Participants with UAS7 <16 at Week 16 of the prior study could enter an observational period before treatment restart if they relapsed.
  • Participants with persistent activity or relapse could receive open-label remibrutinib 100 mg twice daily for up to 52 weeks.

Key Efficacy and Safety Findings

  • Result status: Published

Efficacy

  • 194 of 230 (84.3%) patients from the core study entered the open-label treatment period (remibrutinib 100 mg BID).
  • Mean UAS7 change from baseline: -17.6 at week 4, -21.8 at week 52.
  • Complete response (UAS7 = 0): 28.2% at week 4, 55.8% at week 52.
  • Well-controlled disease (UAS7 <= 6): 52.7% at week 4, 68.0% at week 52.

Safety

  • Safety comparable to core study; most TEAEs mild-to-moderate.
  • Three most common TEAE classes: infections (30.9%), skin/subcutaneous (26.8%), GI disorders (16.5%).

Result source(s)

  • PMID 37866460

Endpoints

  • Primary outcomes:
  • Number of Participants With Treatment-emergent Adverse Events (AEs) (time frame: From first dose of treatment up to 28 days after last dose, assessed up to 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/NCT04109313
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT04109313.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):
  • NCT04109313
  • ../raw/clinicaltrials/markdown/NCT04109313.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.