Generated static export from Obsidian-friendly vault markdown
ClinPharm Vault

Remibrutinib exploratory mixed chronic urticaria study (NCT06865651)

Study Snapshot

  • Program: Remibrutinib
  • Study ID(s): NCT06865651
  • Phase: Phase 2
  • Indication: Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
  • Status: Recruiting
  • Sponsor: Novartis Pharmaceuticals
  • Study family: Mechanistic / exploratory CU program

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: RANDOMIZED
  • Intervention model: PARALLEL
  • Masking: TRIPLE
  • Primary purpose: BASIC_SCIENCE
  • Enrollment: 44 (ESTIMATED)

Population

  • Conditions: Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
  • Sex: ALL
  • Age range: 18 Years to 100 Years
  • Healthy volunteers: False
  • Summary: The purpose of this study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants with Chronic Urticaria (CU), including both Chronic Spontaneous Urticaria (CSU) and Chronic Inducible Urticaria (CINDU).

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: 44 (ESTIMATED)
  • Design interpretation: Exploratory parallel-group mixed-CU study with separate remibrutinib/placebo comparisons in CIndU and CSU strata.
  • Per-arm sample size summary: Novartis trial-page text plus CT.gov support approximately 44 total participants across 4 listed arms and notes the study will attempt to enroll approximately 4 to 5 participants for each included chronic urticaria subtype; exact arm-specific counts are not explicitly stated in the current saved source text.
  • Arm-size evidence source: CT.gov plus cached Novartis trial page NCT06865651.

Arms

Arm Type Dose Frequency Route Description N Evidence status
LOU064-CINDU EXPERIMENTAL NR NR NR Diagnosis of Chronic Inducible Urticaria (CINDU), symptoms of symptomatic dermographism urticaria, cold urticaria, cholinergic urticaria, heat urticaria, solar urticaria, urticaria as diagnosed by pressure, evidence of urticaria after exposure to water, evidence of urticaria following contact to identified material causing urticaria symptoms. NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer
LOU064-CSU EXPERIMENTAL NR NR NR Diagnosis of Chronic Spontaneous Urticaria (CSU) not adequately controlled 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-CINDU PLACEBO_COMPARATOR NR NR NR Diagnosis of Chronic Inducible Urticaria (CINDU), symptoms of symptomatic dermographism urticaria, cold urticaria, cholinergic urticaria, heat urticaria, solar urticaria, urticaria as diagnosed by pressure, evidence of urticaria after exposure to water, evidence of urticaria following contact to identified material causing urticaria symptoms. 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-CSU PLACEBO_COMPARATOR NR NR NR Diagnosis of Chronic Spontaneous Urticaria (CSU) not adequately controlled 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 this as a 12-week randomized participant- and investigator-blinded placebo-controlled exploratory study in chronic urticaria.
  • A linked Novartis trial page is cached locally and explicitly tied to this NCT identifier.
  • Primary outcomes include weekly most-bothersome-symptom NRS and UCT7 weekly scores at week 6.

Endpoints

  • Primary outcomes:
  • Absolute change from baseline in the weekly most bothersome symptom Numeric Rating Scale (NRS) score on the Urticaria Symptom Daily Diary (USDD) (time frame: Baseline, Week 6)
  • Absolute change from baseline in Urticaria Control Test 7 (UCT7) weekly scores (time frame: Baseline, Week 6)

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/NCT06865651
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT06865651.md
  • Sponsor artifacts linked by explicit identifier:
  • Novartis trial page NCT06865651 (Novartis)
    • raw/sponsors/btk/remibrutinib/novartis-trial-page-nct06865651.html
    • raw/sponsors/btk/remibrutinib/novartis-trial-page-nct06865651.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.

Provenance

  • Source type: ClinicalTrials.gov inventory with linked sponsor/publication registry where available
  • Primary source(s):
  • NCT06865651
  • ../raw/clinicaltrials/markdown/NCT06865651.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.