Chronic Spontaneous UrticariaNCT07642557
Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)
An observational study of Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial summary
Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment 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… 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
- 470 participants
- Where
- 1 siteGermany
- Study dates
- 4 Aug 2026to 31 May 2029
- 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 escalate/switch current treatment to remibrutinib
Who may be able to join
- 7.2.1 Inclusion criteria 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 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.
- Cohort3: 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.
Who cannot join
- Patients are excluded if they meet any of the following criteria:
- Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with remibrutinib.
- Patients within the safety follow-up phase of a previous interventional or non-interventional study.
- Patients who received remibrutinib 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
Germany1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Düren, 52349
About this study
Official title: Remibrutinib in Real-world Clinical Practice: a Prospective, Multi-country, Non-interventional, Effectiveness and Safety Study (REASSERT) - Local Adaptation in Germany From Global Umbrella Protocol (CLOU064A2402)
Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment 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 enrolment 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 Germany study is part of an umbrella design which brings 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 clinical outcome of escalated treatment with remibrutinib 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. Baseline visit comprises of clinical assessment before switch to remibrutinib and follow-up visits capture clinical outcome of treatment with remibrutinib as per local label. Enrollment will be capped at a maximum of 30% of the 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)
Achievement of well-controlled disease (UCT7 ≥ 12). 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 (22)
Number and proportion of participants with well-controlled disease and complete disease
Proportion 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 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 from baseline in 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 and the purpose is to estimate any observed difference descriptively.
Measured: Up to 24 months
Number of weeks without angioedema
Number of weeks without angioedema evaluated using application entries.
Measured: Up to 24 months
Change in Angioedema Control Test (AECT)
The AECT consists of 4 questions scored 0 (very much) to 4 (not at all) that measures angioedema control over recent weeks, with a total score ≥10 indicating well-controlled disease
Measured: Baseline, 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
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: Up to 12 weeks
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 12 weeks
Number of participants with administration of remibrutinib according to label
Number of participants with administration of remibrutinib according to label
Measured: Up to 24 weeks
Number of participants with usage of concomitant sgH1-AHs and additional prescribed CSU treatments
Descriptive analysis of concomitant sgH1-AHs
Measured: Up to 24 weeks
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
Composite analytical endpoint comprising the proportion of participants 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 healthcare resource utilisation (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
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
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
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 posted11 Jun 2026
- Study start4 Aug 2026
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (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
- 470 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
- NCT07642557
- Sponsor's protocol ID
- CLOU064ADE02
- Status last verified
- Aug 2026
- First submitted
- 19 May 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 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) - Local Adaptation in Germany From Global Umbrella Protocol (CLOU064A2402)
- ClinicalTrials.gov ID
- NCT07642557
- Acronym / sponsor ID
- CLOU064ADE02
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- Remibrutinib, Non-Interventional Study, Chronic Spontaneous Urticaria, Second-generation H1 antihistamine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 11 Jun 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 CSU where the treatment decision prior enrolment 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 enrolment 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 Germany study is part of an umbrella design which brings 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 clinical outcome of escalated treatment with remibrutinib 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. Baseline visit comprises of clinical assessment before switch to remibrutinib and follow-up visits capture clinical outcome of treatment with remibrutinib as per local label. Enrollment will be capped at a maximum of 30% of the local population. |
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 escalate/switch current treatment to remibrutinib
Key inclusion criteria (7 listed)
- 7.2.1 Inclusion criteria 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)
- Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with remibrutinib.
- Patients within the safety follow-up phase of a previous interventional or non-interventional study.
- Patients who received remibrutinib 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
Achievement of well-controlled disease (UCT7 ≥ 12)
Time frame: 12 weeks after initiating remibrutinib treatment
Achievement of well-controlled disease (UCT7 ≥ 12). 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)
22 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 from baseline in UAS7 score
Time frame: Up to 24 months
Number of weeks without angioedema
Time frame: Up to 24 months
Change in Angioedema Control Test (AECT)
Time frame: Baseline, 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
UCT7 score
Time frame: Up to 12 weeks
UAS7 score
Time frame: Up to 12 weeks
Number of participants with administration of remibrutinib according to label
Time frame: Up to 24 weeks
Number of participants with usage of concomitant sgH1-AHs and additional prescribed CSU treatments
Time frame: Up to 24 weeks
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
Time without escalation, with UCT<12 or UAS7>6
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 7 Aug 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 Germany.
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 7 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 7 Aug 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 Germany. 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?
Achievement of well-controlled disease (UCT7 ≥ 12) (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 7 Aug 2026.