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COMPLETED Phase 3

A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.

NCT05795153 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study was to assess the effect of remibrutinib 25 mg twice a day (b.i.d.) open-label on Systolic Blood Pressure (SBP) measured as a change in 24-hour weighted average SBP from baseline to Week 4 assessed by Ambulator Blood Pressure Monitoring (ABPM); and to assess overall safety and efficacy over 12 weeks in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled with second generation H1 antihistamines (H1-AH) treatment. ABPM was chosen for the blood pressure assessment in this trial as recommended by the FDA for drugs intended for chronic use (Assessment of Pressor Effects of Drugs Guidance for Industry (FDA 2022)).

Interventions

  • DRUG LOU064

Study Locations (20)

Other

  • Novartis Investigative Site — Angers
  • Novartis Investigative Site — Antony
  • Novartis Investigative Site — Brest
  • Novartis Investigative Site — Montpellier

Florida

  • Florida Ctr Allergy Asthma Research — Aventura
  • Finlay Medical Research — Greenacres City

Buenos Aires

  • Novartis Investigative Site — Nueve de Julio
  • Novartis Investigative Site — Sourigues

Arkansas

  • Acuro Research Inc — Little Rock

Idaho

  • Treasure Valley Medical Research — Boise

Illinois

  • Endeavor Health — Glenview

Kentucky

  • Allergy and Asthma Specialist P S C — Owensboro

Oklahoma

  • Allergy Asthma and Clinical Research — Oklahoma City

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2023-04-05
Est. Completion 2024-04-25
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05795153

The ClinicalTrials.gov registry entry for NCT05795153 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chronic Spontaneous Urticaria appearing as the primary indexed condition, and to 1 intervention — of which LOU064 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05795153 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, Florida, Buenos Aires. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05795153 about?

NCT05795153 is a clinical study titled "A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.". The purpose of this study was to assess the effect of remibrutinib 25 mg twice a day (b.i.d.) open-label on Systolic Blood Pressure (SBP) measured as a change in 24-hour weighted average SBP from baseline to Week 4 assessed by Ambulator Blood Pressure Monitoring (ABPM); and to assess overall safety ...

What is the current status of trial NCT05795153?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 144 participants. The study started on 2023-04-05. Estimated completion is 2024-04-25.

What conditions does trial NCT05795153 study?

This clinical trial studies the following conditions: Chronic Spontaneous Urticaria. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05795153?

The interventions under investigation include: LOU064 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05795153?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05795153 being conducted?

This trial has 20 study locations across Arkansas, Florida, Idaho, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial