Chronic Spontaneous UrticariaREASSERTNCT07358364
Remibrutinib in Real-world Clinical Practice
An observational study of Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
Prospective, multi-country, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to remibrutinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Spontaneous Urticaria
- How many people
- 3,280 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2026to 30 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to remibrutinib
Who may be able to join
- Patients with a confirmed diagnosis of primary CSU by the treating physician.
- Aged at least 18 years on the date of enrolment.
- Written informed consent of the patient to participate in the study (according to country specifications) and willingness to complete full follow-up period of 24 months.
- Cohort-specific observational inclusion criteria:
- Cohort 1: Inadequate control of CSU despite licensed dose of sgH1-AH (no other pre-treatments permitted) and decision (independent of study enrolment) to escalate sgH1-AH treatment.
- 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 enrolment) 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 enrolment) 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 three weeks during treatment history, they will be included in cohort 3.
- Note: Candidate patients must not have initiated the next escalated treatment step (i.e. up dosed AH for cohort 1, or remibrutinib for cohorts 2 and 3) prior to their enrolment to ensure the baseline visit captures their clinical status before treatment escalation.
Who cannot join
- 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 MAP/PSDS at any time in the past.
- Patients not capable or willing to continuously provide 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
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
Cleaver Dermatology
Kirksville, Missouri, 63501
About this study
Official title: Remibrutinib in Real-world Clinical Practice: a Prospective, Multi-country, Non-interventional, Effectiveness and Safety Study
Prospective, multi-country, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or 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, multi-country, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or 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. The study employs an umbrella design which brings the evidence needs from multiple countries under the REASSERT global program. Countries will generate local protocol to be used in their country; the local study documentation will be a minimised version of the global document, modified to align with country's evidence needs, given local disparities in treatment guidelines, access, physician type and ePROs/eDiaries used. To achieve the core objectives the observation needs to include either the Urticaria Control Test (UCT) or Urticaria Activity Score over 7 days (UAS7) and the Dermatology Life Quality Index (DLQI). Data from all countries will be pooled and analyzed globally. In certain instances, some modifications of the global protocol may be permitted. For example, in countries where prospective monitoring of off-label antihistamines is prohibited, cohort 1 will not be enrolled.
- 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 1 | Inadequate control of CSU despite licensed dose of sgH1-AH (no other pre-treatments permitted) and decision to escalate sgH1-AH treatment | |
| 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 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 to switch to remibrutinib treatment as per local label |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (well controlled).
Measured: 12 weeks after initiating remibrutinib treatment
UAS7 score
Urticaria Activity Score over 7 days UAS7 is based on 2 daily questions scored 0-3 per day, ranging from 0 (complete control) to 42 (poor control)
Measured: 12 weeks after initiating remibrutinib treatment
Secondary outcomes (32)
Number and proportion of participants with well-controlled disease and complete disease
Proportion of patients with UCT score ≥12 and UAS7 score ≤6. 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 indicates better disease control. Urticaria Activity Score over 7 days (UAS7) is based on 2 daily questions, with daily score of 0 to 6 and weekly score of 0 to 42. Lower scores suggests urticaria free and well controlled urticaria.
Measured: Up to 24 months
Change from baseline (CFB) in UCT score
Change in UCT score over time. 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. Highest scores indicates 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
Change from Baseline in UAS7 score ≥ minimal important difference
Urticaria Activity Score over 7 days (UAS7) is based on 2 daily questions, with daily score of 0 to 6 and weekly score of 0 to 42. Lower scores suggests 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 24 months
Change in angioedema activity score (AAS7) from baseline
Angioedema Activity Score (AAS7) is assessing disease activity over 7 days in patients with urticaria. The score is based on 5 daily questions scored 0 (no discomfort) to 3 (severe discomfort), with weekly score ranging from 0 to 15. Higher scores indicates greater severity of angioedema.
Measured: Up to 24 months
Number of weeks without angioedema
Number of weeks without angioedema evaluated using AECT and/or application entries. Angioedema Control Test (AECT) consists of 4 questions evaluating swelling, rated from 0 (not at all) to 4 (very often) with a maximum score of 16, higher score indicating better control.
Measured: Up to 24 months
Number of participants with rescue medication requirement
Number of participants with rescue medication requirement
Measured: Up to 24 months
Characterize CSU relapse
CSU relapse by frequency and presentation
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 indicates 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
UAS7 score
Urticaria Activity Score over 7 days (UAS7) is based on 2 daily questions, with daily score of 0 to 6 and weekly score of 0 to 42. Lower scores suggests urticaria free and well controlled urticaria. The study is not powered to detect any specific difference, descriptive analysis of difference over time will be presented.
Measured: Up to 24 months
Change in AECT from baseline
Change in AECT score over time will be presented. The study is not powered to detect any specific difference, descriptive analysis of difference over time will be presented. Angioedema Control Test (AECT) is a 4 item questionnaire evaluating swelling within last 4 weeks. Each question is scored from 0 (not at all) to 4 (never), total score ranging from 0 to16. Higher scores represent a well controlled disease.
Measured: Up to 12 weeks
Number of participants with administration of remibrutinib as monotherapy
Number of participants with remibrutinib as monotherapy in cohort 2 and 3
Measured: Up to 24 months
Monotherapy duration
Duration of remibrutinib as monotherapy expressed by days, weeks or months in cohort 2 and 3
Measured: Up to 24 months
Number of participants with Administration of remibrutinib as monotherapy with "on demand" sgH1-AH
Number of participants with Administration of remibrutinib as monotherapy with "on demand" sgH1-AH in cohort 2 and 3
Measured: Up to 24 months
Duration of monotherapy with "on demand" sgH1-AH
Duration of remibrutinib therapy with "on demand" sgH1-AH expressed by days, weeks or months in cohort 2 and 3
Measured: Up to 24 months
Number of participants with usage of concomitant sgH1-AHs and additional prescribed CSU treatments
Descriptive analysis of concomitant sgH1-AHs
Measured: Up to 24 months
Number of participants with administration of CSU-related treatment(s) outside of local and/or international guidelines
Number of participants with administration of CSU-related treatment(s) outside of local and/or international guidelines
Measured: Up to 24 months
Demonstrate relationship between non-adherence to local/international guidelines and impact on patient, disease control, treatment patterns and HCRU during early and long-term follow-up
Demonstrate relationship between non-adherence to local/international guidelines and impact on patient, disease control, treatment patterns and HCRU during early and long-term follow-up
Measured: Up to 24 months
Delay of treatment escalation contrary to local and/or international guidelines when UCT <12 or UAS>6
Delay of treatment escalation contrary within 2-4 weeks from up-dosed sgH1-AH when UCT <12 or UAS>6 at time points measuring UCT7 (early) / UCT (month 3 onwards) / UAS7 group.
This will be measured by time in days/months without escalation, with UCT<12 or UAS7>6 at time points measuring UCT7 / UCT (month 3 onwards) / UAS7 group
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. Urticaria Control Test consists of 4 questions, score below 12 indicates poor disease control. Urticaria Activity Score over 7 days is based on 2 daily questions with a maximum daily score of 6 and weekly total score up to 42. Lower scores indicates better urticaria control.
Measured: Up to 24 months
Number of participants with escalation to remibrutinib
Number of patients with escalation to remibrutinib (cohort 1), time to escalate, prior medications/escalations, and disease control at time of escalation will be presented.
Measured: Up to 24 months
Number of participants with administration of above the licensed dose of sgH1-AH prior to remibrutinib switch
Number of participants receiving escalated doses of sgH1-AH above the licensed dose (2 times, 3 times, 4 times, >4 times) prior to remibrutinib switch. This will be presented for cohort 1 and 2.
Measured: Up to 24 months
Number of sgH1-AH treatment escalations and switches prior to remibrutinib escalation
Number of sgH1-AH treatment escalations and switches prior to remibrutinib escalation
Measured: Up to 24 months
Demonstrate benefit of early vs late treatment escalation to remibrutinib
Demonstrate benefit of early vs late treatment escalation to remibrutinib
Measured: Up to 24 months
Proportion of patients with uncontrolled angioedema escalated to remibrutinib
Presence of angioedema will be reported through App and/or derived from AAS and AECT scores
Measured: Up to 24 months
Proportion of patients requiring corticosteroids prior to switch to remibrutinib
Proportion of patients requiring corticosteroids for disease control prior to switch to remibrutinib (cohort 1 and 2)
Measured: Up to 24 months
Quality of life measured through DLQI score
Dermatology Life Quality Index (DLQI) score 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 evaluated through Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) questionnaire scores
Change over time in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) questionnaire. CU-Q2oL consists of 20 items rated from 0 (never) to 5 (very often). Total score ranges from 0 to 25, with lower scores showing better urticaria control. The study is not powered to detect any specific difference, descriptive analysis of difference over time will be presented.
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 week 12
Quality of life measured through Hospital anxiety and depression scale (HADS)
Quality of life will be evaluated through HADS measuring anxiety and depression components, as well as change from baseline in HADS score. Hospital Anxiety and Depression 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 events related to CSU or Health Care Resource utilisation
Health Care resource utilisation (HCRU) will be evaluated based on quarterly and annualized number of health care resource utilisation related to CSU.
Measured: Up to 24 months
Work productivity and activity impairment (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
Incidence of AEs
Incidence of AEs, including serious AEs in patients who initiated remibrutinib and in patients with sgH1-AH treatment alone
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 posted22 Jan 2026
- Study start2 Feb 2026
- Primary completion30 Oct 2031 (estimated)
- Study completion30 Oct 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
- 3,280 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
- NCT07358364
- Sponsor's protocol ID
- CLOU064A2402
- Acronym
- REASSERT
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 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
- ClinicalTrials.gov ID
- NCT07358364
- Acronym / sponsor ID
- REASSERT / CLOU064A2402
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- Remibrutinib, Non-Interventional Study, Chronic Spontaneous Urticaria, Second-generation H1 antihistamine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,280 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 30 Oct 2031 (estimated)
- Study completion
- 30 Oct 2031 (estimated)
- First posted
- 22 Jan 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, multi-country, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or 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, multi-country, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or 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. The study employs an umbrella design which brings the evidence needs from multiple countries under the REASSERT global program. Countries will generate local protocol to be used in their country; the local study documentation will be a minimised version of the global document, modified to align with country's evidence needs, given local disparities in treatment guidelines, access, physician type and ePROs/eDiaries used. To achieve the core objectives the observation needs to include either the Urticaria Control Test (UCT) or Urticaria Activity Score over 7 days (UAS7) and the Dermatology Life Quality Index (DLQI). Data from all countries will be pooled and analyzed globally. In certain instances, some modifications of the global protocol may be permitted. For example, in countries where prospective monitoring of off-label antihistamines is prohibited, cohort 1 will not be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Inadequate control of CSU despite licensed dose of sgH1-AH (no other pre-treatments permitted) and decision to escalate sgH1-AH treatment |
| 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 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 to switch to remibrutinib treatment as per local label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to remibrutinib
Key inclusion criteria (8 listed)
- Patients with a confirmed diagnosis of primary CSU by the treating physician.
- Aged at least 18 years on the date of enrolment.
- Written informed consent of the patient to participate in the study (according to country specifications) and willingness to complete full follow-up period of 24 months.
- Cohort-specific observational inclusion criteria:
- Note: Candidate patients must not have initiated the next escalated treatment step (i.e. up dosed AH for cohort 1, or remibrutinib for cohorts 2 and 3) prior to their enrolment to ensure the baseline visit captures their clinical status before treatment escalation.
Key exclusion criteria (5 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 MAP/PSDS at any time in the past.
- Patients not capable or willing to continuously provide 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
UCT7 score
Time frame: 12 weeks after initiating remibrutinib treatment
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 (well controlled).
UAS7 score
Time frame: 12 weeks after initiating remibrutinib treatment
Urticaria Activity Score over 7 days UAS7 is based on 2 daily questions scored 0-3 per day, ranging from 0 (complete control) to 42 (poor control)
32 secondary outcomes
Number and proportion of participants with well-controlled disease and complete disease
Time frame: Up to 24 months
Change from baseline (CFB) in UCT score
Time frame: Up to 24 months
Change from Baseline in UAS7 score ≥ minimal important difference
Time frame: Up to 24 months
Change in angioedema activity score (AAS7) from baseline
Time frame: Up to 24 months
Number of weeks without angioedema
Time frame: Up to 24 months
Number of participants with rescue medication requirement
Time frame: Up to 24 months
Characterize CSU relapse
Time frame: Up to 24 months
UCT score
Time frame: Up to 24 months
UAS7 score
Time frame: Up to 24 months
Change in AECT from baseline
Time frame: Up to 12 weeks
Number of participants with administration of remibrutinib as monotherapy
Time frame: Up to 24 months
Monotherapy duration
Time frame: Up to 24 months
Number of participants with Administration of remibrutinib as monotherapy with "on demand" sgH1-AH
Time frame: Up to 24 months
Duration of monotherapy with "on demand" sgH1-AH
Time frame: Up to 24 months
Number of participants with usage of concomitant sgH1-AHs and additional prescribed CSU treatments
Time frame: Up to 24 months
Number of participants with administration of CSU-related treatment(s) 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 HCRU during early and long-term follow-up
Time frame: Up to 24 months
Delay of treatment escalation contrary to local and/or international guidelines when UCT <12 or UAS>6
Time frame: Up to 24 months
Time without escalation, with UCT<12 or UAS7>6
Time frame: Up to 24 months
Number of participants with escalation to remibrutinib
Time frame: Up to 24 months
Number of participants with administration of above the licensed dose of sgH1-AH prior to remibrutinib switch
Time frame: Up to 24 months
Number of sgH1-AH treatment escalations and switches prior to remibrutinib escalation
Time frame: Up to 24 months
Demonstrate benefit of early vs late treatment escalation to remibrutinib
Time frame: Up to 24 months
Proportion of patients with uncontrolled angioedema escalated to remibrutinib
Time frame: Up to 24 months
Proportion of patients requiring corticosteroids prior to switch to remibrutinib
Time frame: Up to 24 months
Quality of life measured through DLQI score
Time frame: Up to 24 months
Quality of life evaluated through Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) questionnaire scores
Time frame: Up to 24 months
Quality of life measured through Sleep interference score
Time frame: Up to week 12
Quality of life measured through Hospital anxiety and depression scale (HADS)
Time frame: Up to 24 months
Number of events related to CSU or Health Care Resource utilisation
Time frame: Up to 24 months
Work productivity and activity impairment (WPAI-CU) score
Time frame: Up to 24 months
Incidence of AEs
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 16 Apr 2026.
- Individual participant dataSharing planned: No
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Chronic Spontaneous Urticaria (CSU)
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 8 inclusion and 5 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 16 Apr 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 (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCT7 score (time frame: 12 weeks after initiating remibrutinib treatment). The study lists 2 primary outcomes in all. 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 16 Apr 2026.