Remibrutinib adolescent Phase 3 CSU study (NCT05677451)

Study Snapshot

• Program: Remibrutinib
• Study ID(s): NCT05677451
• Phase: Phase 3
• Indication: Chronic Spontaneous Urticaria
• Status: Recruiting
• Sponsor: Novartis Pharmaceuticals
• Study family: Pediatric / adolescent expansion

Design

• Study type: INTERVENTIONAL
• Randomization / allocation: RANDOMIZED
• Intervention model: PARALLEL
• Masking: QUADRUPLE
• Primary purpose: TREATMENT
• Enrollment: 100 (ESTIMATED)

Population

• Conditions: Chronic Spontaneous Urticaria
• Sex: ALL
• Age range: 12 Years to 17 Years
• Healthy volunteers: False

• Summary: The purpose of this trial is:

• to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to \< 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines

• to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment
• to collect safety data in this population for up to three years after the last dose of study treatment

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: 100 (ESTIMATED)
• Per-arm sample size summary: 100 total with a 2:1 allocation schema across 2 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

Key source-backed points

• CT.gov describes 24-week double-blind placebo-controlled treatment followed by optional open-label extension and long-term treatment-free follow-up.
• This record explicitly includes pharmacokinetics as part of the study objectives.

Endpoints

• Primary outcomes:
• Change from baseline in UAS7 (time frame: Baseline, week 12)
• Change fron baseline in ISS7 (time frame: Baseline, Week 12)
• Change from baseline in HSS7 (time frame: Baseline, Week 12)

Clinical Pharmacology Findings

• PK: ClinicalTrials.gov summary text indicates pharmacokinetics were part of the study objectives or assessments.
• 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/NCT05677451
• Local CT.gov cache: raw/clinicaltrials/markdown/NCT05677451.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):
• NCT05677451
• ../raw/clinicaltrials/markdown/NCT05677451.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.