Remibrutinib managed access program for CSU (NCT05170724)

Study Snapshot

• Program: Remibrutinib
• Study ID(s): NCT05170724
• Phase: NR
• Indication: Chronic Spontaneous Urticaria
• Status: Available
• Sponsor: Novartis Pharmaceuticals
• Study family: Access / post-development pathway

Design

• Study type: EXPANDED_ACCESS
• Randomization / allocation: None
• Intervention model: None
• Masking: None
• Primary purpose: None
• Enrollment: None (None)

Population

• Conditions: Chronic Spontaneous Urticaria
• Sex: ALL
• Age range: 18 Years to 99 Years
• Healthy volunteers: False
• Summary: The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide access to remibrutinib for adult patients with chronic spontaneous urticaria (CSU)

Operational design summary

• Arms represented in current CT.gov export: NR
• Active dose regimens represented in current local source layer: NR
• Total study enrollment in CT.gov: None (None)
• Design interpretation: Managed access cohort rather than a conventional randomized efficacy trial.
• Per-arm sample size summary: The current CT.gov export does not provide a structured arm table or enrollment target for this managed-access record.
• Arm-size evidence source: ClinicalTrials.gov record metadata.

Arms

Key source-backed points

• CT.gov identifies this as a managed access program cohort treatment plan for adult CSU patients.
• This record should be interpreted separately from the registrational efficacy studies.

Endpoints

• Primary outcomes: NR

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/NCT05170724
• Local CT.gov cache: raw/clinicaltrials/markdown/NCT05170724.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):
• NCT05170724
• ../raw/clinicaltrials/markdown/NCT05170724.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.