Generated static export from Obsidian-friendly vault markdown
ClinPharm Vault

Remibrutinib Phase 3 CIndU basket study (NCT05976243)

Study Snapshot

  • Program: Remibrutinib
  • Study ID(s): NCT05976243
  • Phase: Phase 3
  • Indication: Chronic Inducible Urticaria
  • Status: Active Not Recruiting
  • Sponsor: Novartis Pharmaceuticals
  • Study family: CIndU expansion program

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: RANDOMIZED
  • Intervention model: PARALLEL
  • Masking: TRIPLE
  • Primary purpose: TREATMENT
  • Enrollment: 362 (ACTUAL)

Population

  • Conditions: Chronic Inducible Urticaria
  • Sex: ALL
  • Age range: 18 Years to 100 Years
  • Healthy volunteers: False
  • Summary: This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE).

The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs).

The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data on remibrutinib in participants after having completed the Core period

Operational design summary

  • Arms represented in current CT.gov export: 6
  • Active dose regimens represented in current local source layer: 1
  • Total study enrollment in CT.gov: 362 (ACTUAL)
  • Per-arm sample size summary: 362 total across 6 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, symptomatic dermographism group EXPERIMENTAL NR BID Oral Remibrutinib oral twice daily in participants with symptomatic dermographism 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, symptomatic dermographism group PLACEBO_COMPARATOR NR BID Oral Placebo oral twice daily, symptomatic dermographism NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer
Remibrutinib, cold urticaria group EXPERIMENTAL NR BID Oral Remibrutinib oral twice daily, cold urticaria 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, cold urticaria group PLACEBO_COMPARATOR NR BID Oral Placebo oral twice daily, cold urticaria NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer
Remibrutinib, cholinergic urticaria group EXPERIMENTAL NR BID Oral Remibrutinib oral twice daily, cholinergic urticaria 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, cholinergic urticaria PLACEBO_COMPARATOR NR BID Oral Placebo oral twice daily, cholinergic urticaria 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 362 actual participants in a 52-week randomized double-blind placebo-controlled basket study with open-label extension.
  • Primary endpoints are subtype-specific complete-response measures at week 12 for symptomatic dermographism, cold urticaria, and cholinergic urticaria.
  • This is the main late-stage CIndU branch currently visible in the remibrutinib raw-source layer.

Key Efficacy and Safety Findings

  • Result status: Topline

Efficacy

  • Primary endpoint met for all three CIndU subtypes: significantly higher complete response rates versus placebo at week 12 for symptomatic dermographism, cold urticaria, and cholinergic urticaria.
  • Described as the first therapy to achieve a Phase III primary endpoint in CIndU.

Safety

  • Well-tolerated; favorable safety profile; no liver safety concerns reported in topline release.

Result source(s)

  • Novartis press release, 2026-02-18 (raw/sponsors/btk/remibrutinib/2026-cindu-phase-iii-remind-press-release.md)

Endpoints

  • Primary outcomes:
  • Proportion of participants with complete response in Total Fric Score; symptomatic dermographism (time frame: Week 12)
  • Proportion of participants with complete response in critical temperature threshold; cold urticaria (time frame: Week 12)
  • Proportion of participants with itch numerical rating scale =0; cholinergic urticaria (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/NCT05976243
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT05976243.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):
  • NCT05976243
  • ../raw/clinicaltrials/markdown/NCT05976243.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.