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NCT Number: NCT07408219

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

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.

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Key information

Conditions

Chronic Spontaneous Urticaria Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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.
  • Manage CSU patients within their practice.
  • Enrolled in the research network or are referred HCPs who agree to participate.
  • 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:

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

Exclusion criteria

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

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: RELIEF

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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