Chronic Spontaneous UrticariaRELIEFNCT07408219
A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients
An observational study of Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2026to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
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- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
United States1 site, 1 recruiting
- Recruiting
Novartis
East Hanover, New Jersey, 07936
About this study
Official title: 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.
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- Chronic spontaneous urticaria, Remibrutinib, Dupilumab, Urticaria control test, Urticaria control test 7 day recall
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Urticaria Control Test - 7 Day Recall (UCT-7) Score at Week 4 in Patients Initiating Remibrutinib
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.
Measured: Baseline and Week 4
Secondary outcomes (6)
Change From Baseline in UCT-7 Score at Week 1 in Patients Initiating Remibrutinib
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.
Measured: Baseline and Week 1
Proportion of Patients With a UCT-7 Score ≥12 at Week 1 and Week 4 in Patients Initiating Remibrutinib
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.
Measured: Week 1 and Week 4
Treatment Satisfaction Questionnaire for Medication - Version 9 (TSQM-9) Domain Scores at Week 4 in Patients Initiating Remibrutinib
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.
Measured: Week 4
Change From Baseline in TSQM-9 Domain Scores at Week 4 in Patients Initiating Remibrutinib
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.
Measured: Baseline and Week 4
Treatment Satisfaction Assessed by TSQM-9 Overall Score at Week 4 in Patients Initiating Remibrutinib
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.
Measured: Week 4
Change From Baseline in TSQM-9 Overall Score at Week 4 in Patients Initiating Remibrutinib
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.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start17 Jan 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408219
- Sponsor's protocol ID
- CLOU064AUS05
- Acronym
- RELIEF
- Status last verified
- May 2026
- First submitted
- 6 Feb 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELIEF: Remibrutinib in Chronic Spontaneous Urticaria: Early Real World Effectiveness and Satisfaction Survey
- ClinicalTrials.gov ID
- NCT07408219
- Acronym / sponsor ID
- RELIEF / CLOU064AUS05
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- Chronic spontaneous urticaria, Remibrutinib, Dupilumab, Urticaria control test, Urticaria control test 7 day recall
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Change From Baseline in UCT-7 Score at Week 1 in Patients Initiating Remibrutinib
Time frame: 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
Treatment Satisfaction Questionnaire for Medication - Version 9 (TSQM-9) Domain Scores at Week 4 in Patients Initiating Remibrutinib
Time frame: Week 4
Change From Baseline in TSQM-9 Domain Scores at Week 4 in Patients Initiating Remibrutinib
Time frame: Baseline and Week 4
Treatment Satisfaction Assessed by TSQM-9 Overall Score at Week 4 in Patients Initiating Remibrutinib
Time frame: Week 4
Change From Baseline in TSQM-9 Overall Score at Week 4 in Patients Initiating Remibrutinib
Time frame: Baseline and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.