Remibrutinib in Real-world Clinical Practice - a South Korea Sub-Study
NCT07920315, Not yet recruiting, Novartis Pharmaceuticals
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Remibrutinib in Real-world Clinical Practice - a South Korea Sub-Study | ClinicalTrials.gov |
| NCT number | NCT07920315 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 578 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Novartis Pharmaceuticals | ClinicalTrials.gov |
| Conditions | Chronic Spontaneous Urticaria | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Achievement of Well-Controlled Disease (UCT7 ≥ 12 or UAS7 ≤ 6) | 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). | ClinicalTrials.gov |
| Secondary | Incidence of Adverse Events (AEs) | Up to 24 months | Incidence of AEs, including serious AEs (SAEs), and adverse drug reactions (ADRs) in patients who initiated remibrutinib. | ClinicalTrials.gov |
| Secondary | Number of Patients With Well-Controlled Disease and Complete Control | Up to 24 months | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in UCT Score | Baseline, up to 24 months | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in UAS7 Score ≥ Minimal Important Difference | Baseline, up to 24 months | 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 | ClinicalTrials.gov |
| Secondary | Number of Weeks Without Angioedema | Up to 24 months | ClinicalTrials.gov | |
| Secondary | Change From Baseline in Angioedema Control Test (AECT) | Baseline, up to 24 months | 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. | ClinicalTrials.gov |
| Secondary | Number of Patients With Rescue Medication Requirement | Up to 24 months | ClinicalTrials.gov | |
| Secondary | Characterize CSU Relapse | Up to 24 months | CSU relapse by frequency and presentation. | ClinicalTrials.gov |
| Secondary | UCT7 Score | Up to 12 weeks | 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). | ClinicalTrials.gov |
| Secondary | UAS7 Score | Up to 12 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in UCT7 Score | Baseline, up to 12 weeks | 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). | ClinicalTrials.gov |
| Secondary | Change From Baseline in UAS7 Score | Baseline, up to 24 months | 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. | ClinicalTrials.gov |
| Secondary | Number of Patients With Administration of Remibrutinib Monotherapy | Up to 24 months | ClinicalTrials.gov | |
| Secondary | Duration of Remibrutinib Monotherapy | Up to 24 months | ClinicalTrials.gov | |
| Secondary | Number of Patients With Administration of Remibrutinib According to Label With "On Demand" sgH1-AH Treatment | Up to 24 months | ClinicalTrials.gov | |
| Secondary | Duration of Remibrutinib Monotherapy With "On Demand" sgH1-AH Treatment | Up to 24 months | ClinicalTrials.gov | |
| Secondary | UCT Score | Up to 24 months | 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. | ClinicalTrials.gov |
| Secondary | Number of Patients With Usage of Concomitant sgH1-AH1s and Additional Prescribed CSU Treatments | Up to 24 months | Descriptive analysis of concomitant sgH1-AH1s. | ClinicalTrials.gov |
| Secondary | Number of Patients With Administration of CSU-related Treatments Outside of Local and/or International Guidelines | Up to 24 months | Number of participants with administration of CSU-related treatments outside of local and/or international guidelines by type of treatments. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)