Chronic Spontaneous UrticariaREASSERTNCT07920315
Remibrutinib in Real-world Clinical Practice - a South Korea Sub-Study
An observational study of Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals.
Trial summary
Prospective, non-interventional study in patients with chronic spontaneous urticaria (CSU) where the treatment decision prior enrollment has been made to escalate/switch current treatment to remibrutinib. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- How many people
- 578 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 1 Dec 2031
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CSU where the treatment decision prior enrollment has been made to escalate/switch current treatment to remibrutinib.
Who may be able to join
- Patients must meet all the following criteria to be eligible for inclusion in this study.
- Patients with a confirmed diagnosis of primary CSU by the treating physician.
- Aged at least 18 years on the date of enrollment.
- Written informed consent of the patient to participate in the study and willingness to complete full follow-up period of 24 months.
- Cohort-specific observational inclusion criteria:
- Cohort 2: Inadequate control of CSU despite licensed dose or escalated second-generation H1 antihistamine(s) (sgH1-AH(s)) (no other pre-treatment with exception of first generation H1-AH permitted) with decision (independent of study enrollment) to switch to remibrutinib treatment as per local label.
- Cohort 3: Any other treatment received in addition to H1-AH, any time during patients' CSU treatment history, with decision (independent of study enrollment) to switch to remibrutinib treatment as per local label. Note, occasional steroid rescue medication is out of scope for cohort definition. If a patient had been on continuous steroids for at least 3 weeks during treatment history, they will be included in cohort 3.
- Note: Candidate patients must not have initiated remibrutinib for cohorts 2 and 3 prior to their enrollment to ensure the baseline visit captures their clinical status before treatment escalation.
Who cannot join
- Patients are excluded if they meet any of the following criteria:
- Currently enrolled in a clinical trial or on any experimental treatment.
- Patients within the safety follow-up phase of a previous interventional or non interventional study.
- Patients who received remibrutinib as an investigational medical product during a remibrutinib interventional study or managed access program (MAP)/post study drug supply (PSDS) at any time in the past.
- Patients not capable or willing to continuously provide electronic patient-reported outcome/electronic diary (ePRO/eDiary) data via electronic means throughout the duration of the study.
- Patients who are treated with remibrutinib outside of the local label.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
Official title: Remibrutinib in Real-world Clinical Practice: A Prospective, Multi Country, Non-interventional, Effectiveness and Safety Study (REASSERT)
Prospective, non-interventional study in patients with chronic spontaneous urticaria (CSU) where the treatment decision prior enrollment has been made to escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, a new treatment option, covering a broader, real-world clinical practice population.
Read the detailed description
This is a prospective, non-interventional study in patients with CSU where the treatment decision prior enrollment has been made to escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, covering a broader, real-world clinical practice population. This local South Korea study is part of an umbrella design which brings together the evidence needs from multiple countries under the REASSERT global program (CLOU064A2402).
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- Remibrutinib, Non-Interventional Study, Chronic Spontaneous Urticaria, Second-generation H1 antihistamine
- 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 |
|---|---|---|
| Cohort 2 | Inadequate control of CSU despite licensed dose or escalated sgH1-AH(s) (no other pre-treatment with exception of first generation H1-AH permitted) with decision (independent of study enrollment) to switch to remibrutinib treatment as per local label. Baseline visit comprises of clinical assessment while treated with sgH1-AH (i.e., preescalation to remibrutinib) and follow-up visits capture the clinical outcome of escalated treatment with remibrutinib (with/without sgH1-AH). A minimum enrollment of 40% of the total global and 50% local population is planned, without cap. | |
| Cohort 3 | Any other treatment received in addition to H1-AH, any time during patients' CSU treatment history, with decision (independent of study enrollment) to switch to remibrutinib treatment as per local label. Baseline visit comprises of clinical assessment before switch to remibrutinib and follow-up visits capture clinical outcome of treatment with remibrutinib (with/without sgH1-AH). Enrollment will be capped at a maximum of 30% of the total global and 50% local population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of Well-Controlled Disease (UCT7 ≥ 12 or UAS7 ≤ 6)
Number of patients with UCT7 score ≥ 12 or UAS7 score ≤ 6 at Week 12 after initiating remibrutinib. Urticaria Control Test is looking retrospectively for 7 days (UCT7) and consists of 4 questions. Each question is scored 0-4, with a total score range of 0 (poor control) to 16 (complete control). Urticaria Activity Score over 7 days (UAS7) is based on 2 daily questions, with a daily score of 0 to 6 and a weekly score ranging from 0 (complete control) to 42 (poor control).
Measured: 12 weeks after initiating remibrutinib treatment
Secondary outcomes (27)
Incidence of Adverse Events (AEs)
Incidence of AEs, including serious AEs (SAEs), and adverse drug reactions (ADRs) in patients who initiated remibrutinib.
Measured: Up to 24 months
Number of Patients With Well-Controlled Disease and Complete Control
Number of patients with UCT score ≥12 and UAS7 score ≤6 (well controlled disease) and UCT=16 and UAS7=0 (complete control). Urticaria Control Test (UCT) consists of 4 questions scored 0 (very much) to 4 (not at all), with a total score range of 0 to 16. High scores indicate better disease control. UAS7 is based on 2 daily questions, with a daily score of 0 to 6 and a weekly score of 0 to 42. Lower scores suggest urticaria free and well controlled urticaria.
Measured: Up to 24 months
Change From Baseline in UCT Score
Change in UCT score over time. UCT consists of 4 questions scored 0 (very much) to 4 (not at all), with a total score range of 0 to 16. Higher scores indicate better disease control. The study is not powered to detect any specific difference and the purpose is to estimate any observed difference descriptively.
Measured: Baseline, up to 24 months
Change From Baseline in UAS7 Score ≥ Minimal Important Difference
UAS7 is based on 2 daily questions, with a daily score of 0 to 6 and a weekly score of 0 to 42. Lower scores suggest urticaria free and well controlled urticaria. The study is not powered to detect any specific difference and the purpose is to estimate any observed difference descriptively
Measured: Baseline, up to 24 months
Number of Weeks Without Angioedema
Measured: Up to 24 months
Change From Baseline in Angioedema Control Test (AECT)
Change in AECT score over time will be presented. The study is not powered to detect any specific difference and the purpose is to estimate any observed difference descriptively. AECT is a 4-item questionnaire evaluating swelling within the last 4 weeks. Each question is scored from 0 (not at all) to 4 (never), with the total score ranging from 0 to16. Higher scores represent a well controlled disease.
Measured: Baseline, up to 24 months
Number of Patients With Rescue Medication Requirement
Measured: Up to 24 months
Characterize CSU Relapse
CSU relapse by frequency and presentation.
Measured: Up to 24 months
UCT7 Score
Urticaria Control Test is looking retrospectively for 7 days (UCT7) and consists of 4 questions. Each question is scored 0-4, with a total score range of 0 (poor control) to 16 (complete control).
Measured: Up to 12 weeks
UAS7 Score
UAS7 is based on 2 daily questions, with a daily score of 0 to 6 and a weekly score of 0 to 42. Lower scores suggest urticaria free and well controlled urticaria. The study is not powered to detect any specific difference and the purpose is to estimate any observed difference descriptively.
Measured: Up to 12 weeks
Change From Baseline in UCT7 Score
Urticaria Control Test is looking retrospectively for 7 days (UCT7) and consists of 4 questions. Each question is scored 0-4, with a total score range of 0 (poor control) to 16 (complete control).
Measured: Baseline, up to 12 weeks
Change From Baseline in UAS7 Score
UAS7 is based on 2 daily questions, with a daily score of 0 to 6 and a weekly score of 0 to 42. Lower scores suggest urticaria free and well controlled urticaria. The study is not powered to detect any specific difference and the purpose is to estimate any observed difference descriptively.
Measured: Baseline, up to 24 months
Number of Patients With Administration of Remibrutinib Monotherapy
Measured: Up to 24 months
Duration of Remibrutinib Monotherapy
Measured: Up to 24 months
Number of Patients With Administration of Remibrutinib According to Label With "On Demand" sgH1-AH Treatment
Measured: Up to 24 months
Duration of Remibrutinib Monotherapy With "On Demand" sgH1-AH Treatment
Measured: Up to 24 months
UCT Score
Urticaria Control Test (UCT) consists of 4 questions scored 0 (very much) to 4 (not at all), with a total score range of 0 to 16. High scores indicate better disease control. The study is not powered to detect any specific difference and the purpose is to estimate any observed difference descriptively.
Measured: Up to 24 months
Number of Patients With Usage of Concomitant sgH1-AH1s and Additional Prescribed CSU Treatments
Descriptive analysis of concomitant sgH1-AH1s.
Measured: Up to 24 months
Number of Patients With Administration of CSU-related Treatments Outside of Local and/or International Guidelines
Number of participants with administration of CSU-related treatments outside of local and/or international guidelines by type of treatments.
Measured: Up to 24 months
Demonstrate Relationship Between Non-adherence to Local/International Guidelines and Impact on Patient, Disease Control, Treatment Patterns and Healthcare Resource Utilization (HCRU) During Early and Long-term Follow-up
Composite analytical endpoint comprising the proportion of patients non-adherent to local/international CSU treatment guidelines, and associated impact of patient (WPAI, DLQI), disease control (UAS7, UCT/UCT7), treatment patterns (treatment switches, discontinuations, dose modifications), and HCRU (CSU-related inpatient hospitalizations, length of stay, emergency room visits, outpatient visits) during early (up to Week 12) and long-term (up to Month 24) follow-up.
Measured: Up to 24 months
Number of Patients With a Delay of Treatment Escalation Contrary to Local and/or International Guidelines
Delay of treatment escalation contrary to local and/or international guidelines (recommending escalation within 2-4 weeks from up-dosed sgH1 AH) when UCT score is < 12 or UAS7 score is > 6.
Measured: Up to 24 months
Time Without Escalation, With UCT < 12 or UAS7 > 6
Time in days/months without escalation while UCT score is below 12 OR UAS7 score above 6. UCT consists of 4 questions, a score below 12 indicates poor disease control. UAS7 is based on 2 daily questions, with a daily score of 0 to 6 and a weekly score of 0 to 42. Lower scores indicate better urticaria control.
Measured: Up to 24 months
Quality of Life Measured Through Dermatology Life Quality Index (DLQI) Score
DLQI consists of 10 questions scored from 0 (no impact at all) to 3 (very much). Total score ranges from 0 to 30, with lower scores showing lowest impact of disease on quality of life.
Measured: Up to 24 months
Quality of Life Measured Through Sleep Interference Score
Sleep interference will be evaluated though bespoke question. Maximum score along 7 days ranges from 0 to 21, lower scores showing lowest interference of CSU with sleep.
Measured: Up to 12 weeks
Quality of Life Measured Through Hospital Anxiety and Depression Scale (HADS) Score
Quality of life will be evaluated through HADS measuring anxiety and depression components, as well as change from baseline in HADS score. HADS is a 14 item questionnaire, 7 item rating anxiety and 7 depression. Responses are rated from 0 (never) to 3 (almost all time) at each question. Total score for anxiety and total score for depression range from 0 to 21, higher scores showing higher anxious/depressive symptomatology. Descriptive analysis will be presented.
Measured: Up to 24 months
Number of HCRU Events Related to CSU
HCRU will be evaluated based on quarterly and annualized number of HCRU events related to CSU.
Measured: Up to 24 months
Work Productivity and Activity Impairment-Chronic Urticaria (WPAI-CU) Score
Work productivity assessed through WPAI questionnaire which consists of 6 questions, used to calculate 4 types of scores, absenteeism (work time missed), presenteeism (impairment at work/reduced on the job effectiveness), work productivity loss (overall work impairment), and activity impairment. The scores are expressed in percentage with higher numbers indicating greater impairment and less productivity at work.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion1 Dec 2031 (estimated)
- Study completion1 Dec 2031 (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
- 578 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
- NCT07920315
- Sponsor's protocol ID
- CLOU064AKR01
- Acronym
- REASSERT
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remibrutinib in Real-world Clinical Practice: A Prospective, Multi Country, Non-interventional, Effectiveness and Safety Study (REASSERT)
- ClinicalTrials.gov ID
- NCT07920315
- Acronym / sponsor ID
- REASSERT / CLOU064AKR01
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- Remibrutinib, Non-Interventional Study, Chronic Spontaneous Urticaria, Second-generation H1 antihistamine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 578 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 1 Dec 2031 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 5 Nov 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.
Prospective, non-interventional study in patients with chronic spontaneous urticaria (CSU) where the treatment decision prior enrollment has been made to escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, a new treatment option, covering a broader, real-world clinical practice population.
Detailed description
This is a prospective, non-interventional study in patients with CSU where the treatment decision prior enrollment has been made to escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, covering a broader, real-world clinical practice population. This local South Korea study is part of an umbrella design which brings together the evidence needs from multiple countries under the REASSERT global program (CLOU064A2402).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 2 | – | –Inadequate control of CSU despite licensed dose or escalated sgH1-AH(s) (no other pre-treatment with exception of first generation H1-AH permitted) with decision (independent of study enrollment) to switch to remibrutinib treatment as per local label. Baseline visit comprises of clinical assessment while treated with sgH1-AH (i.e., preescalation to remibrutinib) and follow-up visits capture the clinical outcome of escalated treatment with remibrutinib (with/without sgH1-AH). A minimum enrollment of 40% of the total global and 50% local population is planned, without cap. |
| Cohort 3 | – | –Any other treatment received in addition to H1-AH, any time during patients' CSU treatment history, with decision (independent of study enrollment) to switch to remibrutinib treatment as per local label. Baseline visit comprises of clinical assessment before switch to remibrutinib and follow-up visits capture clinical outcome of treatment with remibrutinib (with/without sgH1-AH). Enrollment will be capped at a maximum of 30% of the total global and 50% local population. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CSU where the treatment decision prior enrollment has been made to escalate/switch current treatment to remibrutinib.
Key inclusion criteria (8 listed)
- Patients must meet all the following criteria to be eligible for inclusion in this study.
- Patients with a confirmed diagnosis of primary CSU by the treating physician.
- Aged at least 18 years on the date of enrollment.
- Written informed consent of the patient to participate in the study and willingness to complete full follow-up period of 24 months.
- Cohort-specific observational inclusion criteria:
Key exclusion criteria (6 listed)
- Currently enrolled in a clinical trial or on any experimental treatment.
- Patients within the safety follow-up phase of a previous interventional or non interventional study.
- Patients who received remibrutinib as an investigational medical product during a remibrutinib interventional study or managed access program (MAP)/post study drug supply (PSDS) at any time in the past.
- Patients not capable or willing to continuously provide electronic patient-reported outcome/electronic diary (ePRO/eDiary) data via electronic means throughout the duration of the study.
- Patients who are treated with remibrutinib outside of the local label.
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
Achievement of Well-Controlled Disease (UCT7 ≥ 12 or UAS7 ≤ 6)
Time frame: 12 weeks after initiating remibrutinib treatment
Number of patients with UCT7 score ≥ 12 or UAS7 score ≤ 6 at Week 12 after initiating remibrutinib. Urticaria Control Test is looking retrospectively for 7 days (UCT7) and consists of 4 questions. Each question is scored 0-4, with a total score range of 0 (poor control) to 16 (complete control). Urticaria Activity Score over 7 days (UAS7) is based on 2 daily questions, with a daily score of 0 to 6 and a weekly score ranging from 0 (complete control) to 42 (poor control).
27 secondary outcomes
Incidence of Adverse Events (AEs)
Time frame: Up to 24 months
Number of Patients With Well-Controlled Disease and Complete Control
Time frame: Up to 24 months
Change From Baseline in UCT Score
Time frame: Baseline, up to 24 months
Change From Baseline in UAS7 Score ≥ Minimal Important Difference
Time frame: Baseline, up to 24 months
Number of Weeks Without Angioedema
Time frame: Up to 24 months
Change From Baseline in Angioedema Control Test (AECT)
Time frame: Baseline, up to 24 months
Number of Patients With Rescue Medication Requirement
Time frame: Up to 24 months
Characterize CSU Relapse
Time frame: Up to 24 months
UCT7 Score
Time frame: Up to 12 weeks
UAS7 Score
Time frame: Up to 12 weeks
Change From Baseline in UCT7 Score
Time frame: Baseline, up to 12 weeks
Change From Baseline in UAS7 Score
Time frame: Baseline, up to 24 months
Number of Patients With Administration of Remibrutinib Monotherapy
Time frame: Up to 24 months
Duration of Remibrutinib Monotherapy
Time frame: Up to 24 months
Number of Patients With Administration of Remibrutinib According to Label With "On Demand" sgH1-AH Treatment
Time frame: Up to 24 months
Duration of Remibrutinib Monotherapy With "On Demand" sgH1-AH Treatment
Time frame: Up to 24 months
UCT Score
Time frame: Up to 24 months
Number of Patients With Usage of Concomitant sgH1-AH1s and Additional Prescribed CSU Treatments
Time frame: Up to 24 months
Number of Patients With Administration of CSU-related Treatments Outside of Local and/or International Guidelines
Time frame: Up to 24 months
Demonstrate Relationship Between Non-adherence to Local/International Guidelines and Impact on Patient, Disease Control, Treatment Patterns and Healthcare Resource Utilization (HCRU) During Early and Long-term Follow-up
Time frame: Up to 24 months
Number of Patients With a Delay of Treatment Escalation Contrary to Local and/or International Guidelines
Time frame: Up to 24 months
Time Without Escalation, With UCT < 12 or UAS7 > 6
Time frame: Up to 24 months
Quality of Life Measured Through Dermatology Life Quality Index (DLQI) Score
Time frame: Up to 24 months
Quality of Life Measured Through Sleep Interference Score
Time frame: Up to 12 weeks
Quality of Life Measured Through Hospital Anxiety and Depression Scale (HADS) Score
Time frame: Up to 24 months
Number of HCRU Events Related to CSU
Time frame: Up to 24 months
Work Productivity and Activity Impairment-Chronic Urticaria (WPAI-CU) Score
Time frame: Up to 24 months
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 5 Nov 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
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals.
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 8 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Achievement of Well-Controlled Disease (UCT7 ≥ 12 or UAS7 ≤ 6) (time frame: 12 weeks after initiating remibrutinib treatment). 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 5 Nov 2026.