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ClinPharm Vault

REMIX-1 remibrutinib pivotal Phase 3 CSU study (NCT05030311)

Study Snapshot

  • Program: Remibrutinib
  • Study ID(s): NCT05030311
  • Phase: Phase 3
  • Indication: Chronic Spontaneous Urticaria
  • Status: Completed
  • Sponsor: Novartis Pharmaceuticals
  • Study family: Pivotal CSU program

Design

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

Population

  • Conditions: Chronic Spontaneous Urticaria
  • Sex: ALL
  • Age range: 18 Years to None
  • Healthy volunteers: False
  • Summary: The purpose of this study was to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo.

Operational design summary

  • Arms represented in current CT.gov export: 2
  • Active dose regimens represented in current local source layer: 1
  • Total study enrollment in CT.gov: 470 (ACTUAL)
  • Design interpretation: 2-arm placebo-controlled pivotal REMIX-1 study with remibrutinib 25 mg twice daily versus placebo.
  • Per-arm sample size summary: 313 remibrutinib, 157 placebo.
  • Arm-size evidence source: PMID 40043237 abstract.

Arms

Arm Type Dose Frequency Route Description N Evidence status
LOU064 25mg b.i.d. EXPERIMENTAL 25mg -> 25 mg BID Oral Patients initially randomized to Remibrutinib during the Double-blind treatment period and continued Remibrutinib during the Open-label treatment period (Up to Week 52) 313 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
Placebo PLACEBO_COMPARATOR 25 mg NR Oral Patients initially randomized to Placebo (Up to Week 24) 157 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context

Key source-backed points

  • PMID 40043237 explicitly identifies this as REMIX-1 and reports 470 randomized patients, with 313 assigned to remibrutinib and 157 to placebo.
  • The week-12 UAS7 least-squares mean change was -20.0 with remibrutinib versus -13.8 with placebo.
  • PMID 41115533 reports sustained week-52 UAS7 improvement for patients originally randomized to remibrutinib and rapid improvement after placebo-to-remibrutinib transition at week 24.

Key Efficacy and Safety Findings

  • Result status: Published

Efficacy

  • Primary endpoint met: week-12 UAS7 LS mean change -20.0 (remibrutinib) versus -13.8 (placebo), P < 0.001.
  • Well-controlled disease (UAS7 <= 6) at week 12: 49.8% versus 24.8% (P < 0.001).
  • Complete response (UAS7 = 0) at week 12: 31.1% versus 10.5% (P < 0.001).
  • 52-week UAS7 change from baseline (remibrutinib): -23.22 (95% CI -24.78 to -21.66); sustained improvement confirmed.
  • Placebo-to-remibrutinib crossover at week 24 showed similar response as early as 1 week after switch.

Safety

  • AE and SAE rates similar between remibrutinib and placebo through week 24.
  • Petechiae higher with remibrutinib (3.8% versus 0.3% in combined REMIX data).
  • Exposure-adjusted AE incidence at 52 weeks remained consistent with the 24-week analysis.

Result source(s)

  • PMID 40043237
  • PMID 41115533

Endpoints

  • Primary outcomes:
  • Change From Baseline in Weekly Urticaria Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint) (time frame: Baseline, Week 12)
  • Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints) (time frame: Baseline, Week 12)
  • Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints) (time frame: Baseline, 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: Primary publication support is available in the registry (PMID 40043237; PMID 41115533).

Safety Findings

  • Safety details should be reviewed in the linked primary publication(s) for fuller interpretation beyond the CT.gov inventory layer.

Linked Evidence

  • CT.gov page: https://clinicaltrials.gov/study/NCT05030311
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT05030311.md
  • Primary publications:
  • PMID 40043237: Remibrutinib in Chronic Spontaneous Urticaria. (../raw/publications/pubmed/markdown/PMID40043237.md)
  • PMID 41115533: Remibrutinib in chronic spontaneous urticaria: 52-week results from two phase 3 studies. (../raw/publications/pubmed/markdown/PMID41115533.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 already has direct manuscript support in the local source layer and should be a higher-priority candidate for manual enrichment.
  • 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 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):
  • NCT05030311
  • ../raw/clinicaltrials/markdown/NCT05030311.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.