An observational study in Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals. Not yet recruiting. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
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.
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).
194 studies on the registry are indexed under Chronic Urticaria; 46 are open to participants now.
This study's planned enrollment of 578 is above the median of 165 across 40 observational studies indexed under Chronic Urticaria.
Browse Chronic Urticaria studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with CSU where the treatment decision prior enrollment has been made to escalate/switch current treatment to remibrutinib.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must meet all the following criteria to be eligible for inclusion in this study.
Cohort-specific observational inclusion criteria:
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.
Exclusion criteria:
Patients are excluded if they meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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).
Time frame: 12 weeks after initiating remibrutinib treatment
Incidence of Adverse Events (AEs)
Incidence of AEs, including serious AEs (SAEs), and adverse drug reactions (ADRs) in patients who initiated remibrutinib.
Time frame: 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.
Time frame: 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.
Time frame: 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
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)
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.
Time frame: Baseline, up to 24 months
Number of Patients With Rescue Medication Requirement
Time frame: Up to 24 months
Characterize CSU Relapse
CSU relapse by frequency and presentation.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
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
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.
Time frame: Up to 24 months
Number of Patients With Usage of Concomitant sgH1-AH1s and Additional Prescribed CSU Treatments
Descriptive analysis of concomitant sgH1-AH1s.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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