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ACTIVE NOT RECRUITING Phase 3

An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib

NCT05513001 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 core studies. This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.

Interventions

  • DRUG Placebo
  • DRUG LOU064 (blinded)
  • DRUG LOU064 (open label)

Study Locations (20)

Florida

  • Florida Ctr Allergy Asthma Research — Aventura
  • Finlay Medical Research — Greenacres City
  • Miami Dade Medical Research — Miami
  • Sarasota Clinical Research — Sarasota
  • Allergy and Asthma Diagnostic Treatment Center — Tallahassee

California

  • Kern Research — Bakersfield
  • Antelope Valley Clinical Trials — Lancaster
  • Allergy and Asthma Consultants — Redwood City

Alabama

  • Allervie Clinical Research — Birmingham
  • Cahaba Derm and skin hlth ctr 27 — Birmingham

Arkansas

  • Acuro Research Inc — Little Rock
  • Arkansas Research Trials — North Little Rock

Colorado

  • Asthma and Allergy Associates P C — Colorado Springs
  • Colorado Allergy and Asthma Ctr PC — Denver

Illinois

  • Endeavor Health — Glenview
  • Asthma and Allergy Center of Chicago S C — River Forest

Arizona

  • Research Solutions of Arizona — Litchfield Park

Connecticut

  • UCONN Health Dermatology — Farmington

Trial Details

FieldValue
Enrollment Target 696 participants
Start Date 2022-12-09
Est. Completion 2027-08-02
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 NCT05513001

The ClinicalTrials.gov registry entry for NCT05513001 describes a study currently listed as active not recruiting. 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 696 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 3 interventions — of which Placebo 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: NCT05513001 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Alabama. 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 NCT05513001 about?

NCT05513001 is a clinical study titled "An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib". The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 core studies. This study wil...

What is the current status of trial NCT05513001?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 696 participants. The study started on 2022-12-09. Estimated completion is 2027-08-02.

What conditions does trial NCT05513001 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 NCT05513001?

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

Who is sponsoring clinical trial NCT05513001?

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 NCT05513001 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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