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ClinPharm Vault

REMIX-2 remibrutinib pivotal Phase 3 CSU study (NCT05032157)

Study Snapshot

  • Program: Remibrutinib
  • Study ID(s): NCT05032157
  • 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: 455 (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 establish the efficacy, safety, and tolerability of Remibrutinib 25 mg b.i.d. in adult patients suffering from chronic spontaneous urticaria (CSU) inadequately controlled by second generation H1-antihistamines (H1-AHs) 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: 455 (ACTUAL)
  • Design interpretation: 2-arm placebo-controlled pivotal REMIX-2 study with remibrutinib 25 mg twice daily versus placebo.
  • Per-arm sample size summary: 300 remibrutinib, 155 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 BID Oral LOU064A (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064 (open- label) taken orally b.i.d. for 28 weeks. Randomised in 2:1 ratio (active vs placebo) 300 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
Placebo PLACEBO_COMPARATOR NR BID Oral LOU064A placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally b.i.d. for 28 weeks. Randomised in 2:1 ratio (active vs placebo) 155 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-2 and reports 455 randomized patients, with 300 assigned to remibrutinib and 155 to placebo.
  • The week-12 UAS7 least-squares mean change was -19.4 with remibrutinib versus -11.7 with placebo.
  • PMID 41115533 reports sustained week-52 benefit and consistent long-term safety across the REMIX phase 3 program.

Key Efficacy and Safety Findings

  • Result status: Published

Efficacy

  • Primary endpoint met: week-12 UAS7 LS mean change -19.4 (remibrutinib) versus -11.7 (placebo), P < 0.001.
  • Well-controlled disease (UAS7 <= 6) at week 12: 46.8% versus 19.6% (P < 0.001).
  • Complete response (UAS7 = 0) at week 12: 27.9% versus 6.5% (P < 0.001).
  • 52-week UAS7 change from baseline (remibrutinib): -22.98 (95% CI -24.51 to -21.44); sustained benefit confirmed.

Safety

  • Safety profile consistent with REMIX-1; no new signals at 52 weeks.
  • Most common AEs (>= 5%): respiratory tract infections and headache, comparable with placebo.
  • Liver transaminase elevations balanced across arms; all asymptomatic, transient, and reversible.

Result source(s)

  • PMID 40043237
  • PMID 41115533

Endpoints

  • Primary outcomes:
  • Mean Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint) (time frame: Baseline, Week 12)
  • Mean 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)
  • Mean 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/NCT05032157
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT05032157.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):
  • NCT05032157
  • ../raw/clinicaltrials/markdown/NCT05032157.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.