A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients (RELIEF)

May 6, 2026 updated by: Novartis Pharmaceuticals

RELIEF: Remibrutinib in Chronic Spontaneous Urticaria: Early Real World Effectiveness and Satisfaction Survey

This is a United States (US) based, prospective, non-interventional, provider-referral study to evaluate the real-world effectiveness and patient-centered outcomes of remibrutinib in chronic spontaneous urticaria (CSU) patients using validated patient reported outcome (PRO) tools.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Recruiting
        • Novartis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

CSU patients who are prescribed and initiating treatment with remibrutinib or dupilumab, and who are invited to participate following a referral from their HCP.

Description

Inclusion criteria:

Healthcare provider (HCP) participants eligible to refer patients for inclusion in this study must meet all the following criteria:

  1. Have an active medical license and be board certified/board eligible allergist or dermatologist in the US. Nurse practitioners and physician assistant practicing in allergy and dermatology are eligible.
  2. Manage CSU patients within their practice.
  3. Enrolled in the research network or are referred HCPs who agree to participate.

  4. Have the requisite patient population based on study inclusion/exclusion criteria.

    Patients eligible for inclusion in this study must meet all of the following criteria:

  5. ≥ 18 years of age.
  6. Diagnosed with CSU by an HCP.
  7. Have received a prescription for remibrutinib or dupilumab and are expected to initiate treatment.
  8. Have access to an electronic device with internet capabilities.
  9. Able to read and understand English.
  10. Willing and able to provide consent for study participation.

Exclusion criteria:

Patients will be excluded if they meet any of the following criteria:

  1. Unable to procure remibrutinib or dupilumab (through samples, commercially or patient assistance program).
  2. Exposure to oral corticosteroid treatment in 14 days prior to consent.
  3. Exposure to oral corticosteroid treatment in 14 days prior to initiating treatment with remibrutinib or dupilumab.
  4. Prior participation in a remibrutinib or dupilumab clinical trial.
  5. Cognitive impairment that impacts the patient's ability to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Remibrutinib Cohort
Adult patients with CSU who are prescribed and initiating treatment with remibrutinib.
Dupilumab Cohort
Adult patients with CSU who are prescribed and initiating treatment with dupilumab.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Urticaria Control Test - 7 Day Recall (UCT-7) Score at Week 4 in Patients Initiating Remibrutinib
Time Frame: Baseline and Week 4
UCT-7 is a validated PRO tool designed to assess disease control over a 7-day recall period. It evaluates symptom burden, quality of life impact, treatment adequacy, and overall disease control. It consists of 4 questions, each of which is scored 0-4, with a total score range of 0-16. A score of <12 indicates poor disease control, 12-15 = partial control, and 16 indicates complete control.
Baseline and Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in UCT-7 Score at Week 1 in Patients Initiating Remibrutinib
Time Frame: Baseline and Week 1
UCT-7 is a validated PRO tool designed to assess disease control over a 7-day recall period. It evaluates symptom burden, quality of life impact, treatment adequacy, and overall disease control. It consists of 4 questions, each of which is scored 0-4, with a total score range of 0-16. A score of <12 indicates poor disease control, 12-15 = partial control, and 16 indicates complete control.
Baseline and Week 1
Proportion of Patients With a UCT-7 Score ≥12 at Week 1 and Week 4 in Patients Initiating Remibrutinib
Time Frame: Week 1 and Week 4
UCT-7 is a validated PRO tool designed to assess disease control over a 7-day recall period. It evaluates symptom burden, quality of life impact, treatment adequacy, and overall disease control. It consists of 4 questions, each of which is scored 0-4, with a total score range of 0-16. A score of <12 indicates poor disease control, 12-15 = partial control, and 16 indicates complete control.
Week 1 and Week 4
Treatment Satisfaction Questionnaire for Medication - Version 9 (TSQM-9) Domain Scores at Week 4 in Patients Initiating Remibrutinib
Time Frame: Week 4
The TSQM-9 is a validated PRO tool used to determine patient perceptions of the benefits, convenience, and overall satisfaction with their CSU treatment. It asks about 3 domains: effectiveness, convenience, and global satisfaction. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain.
Week 4
Change From Baseline in TSQM-9 Domain Scores at Week 4 in Patients Initiating Remibrutinib
Time Frame: Baseline and Week 4
The TSQM-9 is a validated PRO tool used to determine patient perceptions of the benefits, convenience, and overall satisfaction with their CSU treatment. It asks about 3 domains: effectiveness, convenience, and global satisfaction. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. A positive change from baseline indicates improvement.
Baseline and Week 4
Treatment Satisfaction Assessed by TSQM-9 Overall Score at Week 4 in Patients Initiating Remibrutinib
Time Frame: Week 4
The TSQM-9 is a validated PRO tool used to determine patient perceptions of the benefits, convenience, and overall satisfaction with their CSU treatment. It asks about 3 domains: effectiveness, convenience, and global satisfaction. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. Scores are produced for each domain, and total scores are calculated and used to assess overall medication satisfaction.
Week 4
Change From Baseline in TSQM-9 Overall Score at Week 4 in Patients Initiating Remibrutinib
Time Frame: Baseline and Week 4
The TSQM-9 is a validated PRO tool used to determine patient perceptions of the benefits, convenience, and overall satisfaction with their CSU treatment. It asks about 3 domains: effectiveness, convenience, and global satisfaction. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. Scores are produced for each domain, and total scores are calculated and used to assess overall medication satisfaction. A positive change from baseline indicates improvement.
Baseline and Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLOU064AUS05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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