Trial · NCT05030311
A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines
NCT05030311, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2024-12-02
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines. Trials, record NCT05030311. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05030311
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines
- NCT number
- NCT05030311
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 470 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- LOU064 25 mg (b.i.d), Placebo, LOU064 25 mg (b.i.d) as a tablet.
- First posted
- 2021-09-01
- Last updated
- 2025-04-08
- Other registries' IDs
- eudract:2022-001034-11
- Results first posted
- 2024-12-02
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Weekly Urticaria Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint) | Baseline, Week 12 | The Weekly Urticaria Activity Score (UAS7) is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42 (highest urticaria severity), and a minimum possible score of 0. This endpoint is a secondary endpoint for testing strategy Scenario 2 with Weekly Itch Severity Score (ISS7) and Weekly Hives Severity Score (HSS7) as co-primary efficacy endpoints). |
| Primary | Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints) | Baseline, Week 12 | The severity of the itch was recorded by the participant twice daily in their electronic Diary, on a scale of 0 (none) to 3 (severe). A weekly score (ISS7) was derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score was therefore 0 - 21 (highest itch severity). This endpoint is a secondary endpoint for testing strategy Scenario 1 with Weekly Urticaria Activity Score (UAS7) as the primary efficacy endpoint). |
| Primary | Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints) | Baseline, Week 12 | The hives (wheals) severity score, defined by number of hives, was recorded by the participant twice daily in their electronic Diary, on a scale of 0 (none) to 3 (\> 12 hives/12 hours). A weekly score (HSS7) was derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score was therefore 0 - 21 (highest hives activity). This endpoint is a secondary endpoint for testing strategy Scenario 1 with Weekly Urticaria Activity Score (UAS7) as the primary efficacy endpoint. |
| Secondary | Number of Patients Who Achieved Disease Activity Control (UAS7 ≤6) | Week 12 | The percentage of patients achieving disease activity control (UAS7 =\< 6) at Week 12 was assessed to evaluate the efficacy of Remibrutinib in Chronic Spontaneous Urticaria (CSU) patients. The UAS7 is the sum of the Weekly Hives Severity Score (HSS7) and the Weekly Itch Severity Score (ISS7). The possible range of the UAS7 score is 0 - 42 (highest hives and itch severity). |
| Secondary | Number of Patients Who Achieved Complete Absence of Hives and Itch (UAS7 = 0) | Week 12 | The number of patients achieving complete absence of hives and itch (UAS7 = 0) at Week 12 was assessed to evaluate the efficacy of Remibrutinib in Chronic Spontaneous Urticaria (CSU) patients. The UAS7 is the sum of the Weekly Hives Severity Score (HSS7) and the Weekly Itch Severity Score (ISS7). The possible range of the UAS7 score is 0 - 42 (highest hives and itch severity). |
| Secondary | Number of Patients With Early Onset of Disease Control (UAS7 ≤ 6 at Week 2) | Week 2 | The percentage of patients achieving disease activity control (UAS7 =\< 6) at Week 2 was assessed to evaluate the efficacy of Remibrutinib in Chronic Spontaneous Urticaria (CSU) patients. The UAS7 is the sum of the Weekly Hives Severity Score (HSS7) and the Weekly Itch Severity Score (ISS7). The possible range of the UAS7 score is 0 - 42 (highest hives and itch severity). |
| Secondary | Cumulative Number of Weeks With Disease Activity Control (UAS7 <= 6) up to Week 12 | up to Week 12 | Maintaining disease activity control was assessed as cumulative number of weeks with an UAS7 =\< 6 response between baseline and Week 12. The UAS7 is the sum of the Weekly Hives Severity Score (HSS7) and the Weekly Itch Severity Score (ISS7). The possible range of the UAS7 score is 0 - 42 (highest hives and itch severity). |
| Secondary | Number of Patients Who Achieved DLQI = 0 - 1 | Week 12 | The Dermatology Life Quality Index (DLQI) is a 10-item (grouped in 6 domains) dermatology-specific quality of life (QoL) measure. Participants are rating their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score is calculated and ranges from 0 to 30 (higher score meaning worse disease-related QoL). Domain scores are calculated for: Symptoms and Feelings (0-6), Daily Activities (0-6), Leisure (0-6), Work and School (0-3), Personal Relationships (0-6), Treatment (0-3). The overall DLQI score range was split into score bands and validated in terms of their meaning/relevance to patients overall. DLQI = 0-1 means no effect on patient's life. |
| Secondary | Cumulative Number of Weeks Without Angioedema (AAS7 = 0) | Up to Week 12 | Angioedema occurrence was recorded once daily in the evening in the electronic Diary by the participant. Reporting the occurrence of angioedema was used as opening question for the assessment of the Angioedema Activity Score (AAS). The AAS consists of 5 questions with 4 answer options (scored 0-3) for each item, with a minimum score of 0 and a maximum score of 15 per day. The AAS score over 7 days (AAS7) ranges from 0 (no angioedema episodes) to 105 (highest angioedema severity). |
| Secondary | Number of Participants With Adverse Events | On-treatment adverse events are reported from first dose of study medication up to 28 days after last dose of study medication, for a timeframe up to approximately 56 weeks | An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Weekly Urticaria Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint) | Baseline, Week 12 | Full Analysis Set (FAS) | Scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints) | Baseline, Week 12 | Full Analysis Set (FAS) | Scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints) | Baseline, Week 12 | Full Analysis Set (FAS) | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients Who Achieved Disease Activity Control (UAS7 ≤6) | Week 12 | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Who Achieved Complete Absence of Hives and Itch (UAS7 = 0) | Week 12 | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Early Onset of Disease Control (UAS7 ≤ 6 at Week 2) | Week 2 | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cumulative Number of Weeks With Disease Activity Control (UAS7 <= 6) up to Week 12 | up to Week 12 | Full Analysis Set (FAS) | weeks | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients Who Achieved DLQI = 0 - 1 | Week 12 | Full Analysis Set (FAS) - for patients with a valid measurement without a protocol deviation with impact. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cumulative Number of Weeks Without Angioedema (AAS7 = 0) | Up to Week 12 | Full Analysis Set (FAS) | Weeks | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Adverse Events | On-treatment adverse events are reported from first dose of study medication up to 28 days after last dose of study medication, for a timeframe up to approximately 56 weeks | Safety Set (SAF) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Weekly Urticaria Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint) | LOU064 25mg b.i.d. | -20.02 | Standard Error 0.716 | Scores on a scale | |
| Change From Baseline in Weekly Urticaria Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint) | Placebo | -13.79 | Standard Error 0.980 | Scores on a scale | |
| Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints) | LOU064 25mg b.i.d. | -9.52 | Standard Error 0.343 | Scores on a scale | |
| Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints) | Placebo | -6.89 | Standard Error 0.470 | Scores on a scale | |
| Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints) | LOU064 25mg b.i.d. | -10.47 | Standard Error 0.401 | Scores on a scale | |
| Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints) | Placebo | -6.86 | Standard Error 0.548 | Scores on a scale | |
| Number of Patients Who Achieved Disease Activity Control (UAS7 ≤6) | LOU064 25mg b.i.d. | 154 | Participants | ||
| Number of Patients Who Achieved Disease Activity Control (UAS7 ≤6) | Placebo | 38 | Participants | ||
| Number of Patients Who Achieved Complete Absence of Hives and Itch (UAS7 = 0) | LOU064 25mg b.i.d. | 96 | Participants | ||
| Number of Patients Who Achieved Complete Absence of Hives and Itch (UAS7 = 0) | Placebo | 16 | Participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LOU064 25mg b.i.d. | 313 | |
| Overall Study | STARTED | Placebo | 157 | |
| Overall Study | Safety Set | LOU064 25mg b.i.d. | 309 | |
| Overall Study | Safety Set | Placebo | 153 | |
| Overall Study | Full Analysis Set (FAS) | LOU064 25mg b.i.d. | 309 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 153 | |
| Overall Study | COMPLETED | LOU064 25mg b.i.d. | 251 | |
| Overall Study | COMPLETED | Placebo | 124 | |
| Overall Study | NOT COMPLETED | LOU064 25mg b.i.d. | 62 | |
| Overall Study | NOT COMPLETED | Placebo | 33 |
Source ClinicalTrials.gov
Adverse events90
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 |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | LOU064 25mg b.i.d. | 11 | 309 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 7 | 153 | |
| other | Diarrhoea | Gastrointestinal disorders | Transitioned to LOU064 25mg b.i.d. | 2 | 133 | |
| other | Nausea | Gastrointestinal disorders | LOU064 25mg b.i.d. | 11 | 309 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 153 | |
| other | Nausea | Gastrointestinal disorders | Transitioned to LOU064 25mg b.i.d. | 0 | 133 | |
| other | Pyrexia | General disorders | LOU064 25mg b.i.d. | 10 | 309 | |
| other | Pyrexia | General disorders | Placebo | 3 | 153 | |
| other | Pyrexia | General disorders | Transitioned to LOU064 25mg b.i.d. | 1 | 133 | |
| other | COVID-19 | Infections and infestations | LOU064 25mg b.i.d. | 31 | 309 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LOU064 25mg b.i.d. | 0 | 309 |
| Total, all-cause mortality | Placebo | 0 | 153 |
| Total, all-cause mortality | Transitioned to LOU064 25mg b.i.d. | 0 | 133 |
| Total, other adverse events | LOU064 25mg b.i.d. | 139 | 309 |
| Total, other adverse events | Placebo | 53 | 153 |
| Total, other adverse events | Transitioned to LOU064 25mg b.i.d. | 26 | 133 |
| Total, serious adverse events | LOU064 25mg b.i.d. | 13 | 309 |
| Total, serious adverse events | Placebo | 1 | 153 |
| Total, serious adverse events | Transitioned to LOU064 25mg b.i.d. | 1 | 133 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| LOU064 25mg b.i.d. vs Placebo: Number of Patients Who Achieved DLQI = 0 - 1 | Trial comparisons |
| LOU064 25mg b.i.d. vs Placebo: Number of Patients Who Achieved Disease Activity Control (UAS7 ≤6) | Trial comparisons |
| LOU064 25mg b.i.d. vs Placebo: Number of Patients With Early Onset of Disease Control (UAS7 ≤ 6 at Week 2) | Trial comparisons |
| LOU064 25mg b.i.d. vs Placebo: Number of Patients Who Achieved Complete Absence of Hives and Itch (UAS7 = 0) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05030311
GET https://conductscience.org/api/trials/v1/NCT05030311/results?page=2