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ClinPharm Vault

Remibrutinib Phase 2b dose-finding CSU study (NCT03926611)

Study Snapshot

  • Program: Remibrutinib
  • Study ID(s): NCT03926611
  • Phase: Phase 2
  • Indication: Chronic Spontaneous Urticaria
  • Status: Completed
  • Sponsor: Novartis Pharmaceuticals
  • Study family: Foundational CSU efficacy program

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: RANDOMIZED
  • Intervention model: PARALLEL
  • Masking: TRIPLE
  • Primary purpose: TREATMENT
  • Enrollment: 311 (ACTUAL)

Population

  • Conditions: Chronic Spontaneous Urticaria
  • Sex: ALL
  • Age range: 18 Years to 99 Years
  • Healthy volunteers: False
  • Summary: This was a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by H1-antihistamines

Operational design summary

  • Arms represented in current CT.gov export: 7
  • Active dose regimens represented in current local source layer: 6
  • Total study enrollment in CT.gov: 311 (ACTUAL)
  • Design interpretation: 7-arm dose-finding study with 6 active oral remibrutinib regimens plus placebo.
  • Per-arm sample size summary: ClinicalTrials.gov results-section denominators support randomized group sizes of 44 (Arm 1), 44 (Arm 2), 47 (Arm 3), 44 (Arm 4), 44 (Arm 5), 45 (Arm 6), and 43 (placebo), totaling 311 participants.
  • Arm-size evidence source: ClinicalTrials.gov API v2 resultsSection participant flow and baseline-characteristics denominators, plus PMID 36096203 abstract.

Arms

Arm Type Dose Frequency Route Description N Evidence status
LOU064 Arm 1 EXPERIMENTAL 10 mg QD Oral 10 mg LOU064 qd capsule once daily 44 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
LOU064 Arm 2 EXPERIMENTAL 35 mg QD Oral 35 mg capsule qd LOU064 once daily 44 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
LOU064 Arm 3 EXPERIMENTAL 100 mg QD Oral 100 mg capsule qd LOU064 once daily 47 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
LOU064 Arm 4 EXPERIMENTAL 10 mg BID Oral 10 mg capsule LOU064 bid 44 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
LOU064 Arm 5 EXPERIMENTAL 25 mg BID Oral 25 mg capsule LOU064 bid 44 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
LOU064 Arm 6 EXPERIMENTAL 100 mg BID Oral 100 mg capsule LOU064 bid 45 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
Placebo Arm PLACEBO_COMPARATOR NR BID NR Participants took matching placebo twice daily 43 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context

Key source-backed points

  • PMID 36096203 identifies this as the randomized phase 2b CSU dose-finding trial and reports 311 randomized patients across 6 remibrutinib regimens plus placebo.
  • The manuscript reports week-4 UAS7 change from baseline ranging from -14.7 to -20.0 across active doses versus -5.4 for placebo.
  • The saved abstract describes rapid onset of action with symptom reduction from week 1 through week 12.

Key Efficacy and Safety Findings

  • Result status: Published

Efficacy

  • Primary endpoint (UAS7 change from baseline at week 4): LS mean ranged from -14.7 to -20.0 across 6 active dose regimens versus -5.4 for placebo; nominal P < 0.0001 for all doses versus placebo.
  • Best-performing regimen (25 mg BID): week-4 UAS7 change -20.0 versus -5.4 placebo.
  • Rapid onset of symptom reduction observed from week 1 through week 12.

Safety

  • Most adverse events were mild or moderate with no dose-dependent pattern.

Result source(s)

  • PMID 36096203

Endpoints

  • Primary outcomes:
  • Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 (time frame: Baseline, Week 4)

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 36096203; PMID 37866460).

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/NCT03926611
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT03926611.md
  • Primary publications:
  • PMID 36096203: Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria. (../raw/publications/pubmed/markdown/PMID36096203.md)
  • PMID 37866460: Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks. (../raw/publications/pubmed/markdown/PMID37866460.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):
  • NCT03926611
  • ../raw/clinicaltrials/markdown/NCT03926611.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.