Generated static export from Obsidian-friendly vault markdown
ClinPharm Vault

Remibrutinib Phase 3b omalizumab-controlled CSU study (NCT06042478)

Study Snapshot

  • Program: Remibrutinib
  • Study ID(s): NCT06042478
  • Phase: Phase 3
  • Indication: Chronic Spontaneous Urticaria
  • Status: Active Not Recruiting
  • Sponsor: Novartis Pharmaceuticals
  • Study family: Comparator / positioning program

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: RANDOMIZED
  • Intervention model: PARALLEL
  • Masking: TRIPLE
  • Primary purpose: TREATMENT
  • Enrollment: 470 (ACTUAL)

Population

  • Conditions: Chronic Spontaneous Urticaria
  • Sex: ALL
  • Age range: 18 Years to 100 Years
  • Healthy volunteers: False
  • Summary: The purpose of the core phase of the trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every 4 weeks (q4w) for 52 weeks in participants with chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines (H1-AH).

The purpose of the open-label extension phase is to assess efficacy, safety and tolerability up to two years for patients treated with remibrutinib and patients transitioned from omalizumab to remibrutinib at Week 52. In the extension phase, treatment will be with remibrutinib only (i.e., no background therapy). The extension phase will also fulfill the Novartis commitment to provide post-trial access to participants of the previous core phase.

Operational design summary

  • Arms represented in current CT.gov export: 4
  • Active dose regimens represented in current local source layer: 2
  • Total study enrollment in CT.gov: 470 (ACTUAL)
  • Per-arm sample size summary: 470 total across 4 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
Remibrutinib EXPERIMENTAL 25 mg BID + Q4W NR Participants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 52 weeks. NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer
Placebo to remibrutinib PLACEBO_COMPARATOR 25 mg BID + Q4W NR Participants will receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w. NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer
Placebo to omalizumab PLACEBO_COMPARATOR 25 mg -> 300 mg BID + Q4W NR Participants will receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d. NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer
Omalizumab ACTIVE_COMPARATOR 300 mg BID + Q4W NR participants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d. for 52 weeks. 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 a four-arm double-dummy design including remibrutinib, omalizumab, and two placebo-to-active transition arms.
  • The primary endpoint is absolute change from baseline in UAS7 at week 12.

Endpoints

  • Primary outcomes:
  • Absolute change from baseline in Weekly Urticaria Activity Score (UAS7) (time frame: Week 12)

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/NCT06042478
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT06042478.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):
  • NCT06042478
  • ../raw/clinicaltrials/markdown/NCT06042478.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.