Trial · NCT05032157
A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistamines
NCT05032157, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2024-11-01
3 sourcestrials-2026-11-12-0.5.0
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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 NCT05032157. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05032157
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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
- NCT05032157
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 455 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- LOU064 (blinded), Placebo, LOU064 (open-label)
- First posted
- 2021-09-02
- Last updated
- 2025-04-08
- Other registries' IDs
- eudract:2021-000424-35
- Results first posted
- 2024-11-01
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Weekly Urticaria Activity 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 | Mean 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 | Mean 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 Participants Who Achieved Disease Activity Control (UAS7 =< 6) at Week 12 | 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 Participants Who Achieved Complete Absence of Hives and Itch (UAS7 = 0) at Week 12 | Week 12 | The proportion 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 Participants Who Achieved Early Onset of Disease Activity 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 | Number of Participants Who Achieved Dermatology Life Quality Index (DLQI) = 0-1 at Week 12 | 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 | Mean 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 | Mean Cumulative Number of Angioedema Occurrence-free Weeks (AAS7 = 0 Response) up to Week 12 | 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 Treatment Emergent Adverse Events | Baseline up to 28 days after last dose of study medication, assessed 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. Treatment emergent Adverse Event (TEAEs) in this study are events that started after the first dose of study treatment and until 28 days after the last dose of study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 28 days after the last study treatment. |
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 | Mean Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint) | Baseline, Week 12 | Full Analysis Set (FAS) | Unit on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Mean 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) | Unit on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Mean 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) | Unit on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Who Achieved Disease Activity Control (UAS7 =< 6) at Week 12 | Week 12 | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved Complete Absence of Hives and Itch (UAS7 = 0) at Week 12 | Week 12 | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved Early Onset of Disease Activity Control (UAS7 =< 6) at Week 2 | Week 2 | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved Dermatology Life Quality Index (DLQI) = 0-1 at Week 12 | Week 12 | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean 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 | Mean Cumulative Number of Angioedema Occurrence-free Weeks (AAS7 = 0 Response) up to Week 12 | Up to Week 12 | Full Analysis Set (FAS) | Weeks | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events | Baseline up to 28 days after last dose of study medication, assessed up to approximately 56 weeks | Safety Set (SAF) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint) | LOU064 25 mg b.i.d. | -19.41 | Standard Error 0.702 | Unit on a scale | |
| Mean Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint) | Placebo | -11.73 | Standard Error 0.948 | Unit on a scale | |
| Mean Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints) | LOU064 25 mg b.i.d. | -8.95 | Standard Error 0.335 | Unit on a scale | |
| Mean Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints) | Placebo | -5.72 | Standard Error 0.454 | Unit on a scale | |
| Mean Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints) | LOU064 25 mg b.i.d. | -10.47 | Standard Error 0.394 | Unit on a scale | |
| Mean Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints) | Placebo | -6.00 | Standard Error 0.531 | Unit on a scale | |
| Number of Participants Who Achieved Disease Activity Control (UAS7 =< 6) at Week 12 | LOU064 25 mg b.i.d. | 139 | Participants | ||
| Number of Participants Who Achieved Disease Activity Control (UAS7 =< 6) at Week 12 | Placebo | 30 | Participants | ||
| Number of Participants Who Achieved Complete Absence of Hives and Itch (UAS7 = 0) at Week 12 | LOU064 25 mg b.i.d. | 83 | Participants | ||
| Number of Participants Who Achieved Complete Absence of Hives and Itch (UAS7 = 0) at Week 12 | Placebo | 10 | Participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 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 25 mg b.i.d. | 300 | |
| Overall Study | STARTED | Placebo | 155 | |
| Overall Study | Full Analysis Set (FAS) | LOU064 25 mg b.i.d. | 297 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 153 | |
| Overall Study | Safety Set (SAF) | LOU064 25 mg b.i.d. | 297 | |
| Overall Study | Safety Set (SAF) | Placebo | 153 | |
| Overall Study | COMPLETED | LOU064 25 mg b.i.d. | 230 | |
| Overall Study | COMPLETED | Placebo | 111 | |
| Overall Study | NOT COMPLETED | LOU064 25 mg b.i.d. | 70 | |
| Overall Study | NOT COMPLETED | Placebo | 44 |
Source ClinicalTrials.gov
Adverse events111
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 | COVID-19 | Infections and infestations | LOU064 25 mg b.i.d. | 62 | 297 | |
| other | COVID-19 | Infections and infestations | Placebo | 21 | 153 | |
| other | COVID-19 | Infections and infestations | Transitioned to LOU064 25 mg b.i.d. | 13 | 129 | |
| other | Influenza | Infections and infestations | LOU064 25 mg b.i.d. | 8 | 297 | |
| other | Influenza | Infections and infestations | Placebo | 2 | 153 | |
| other | Influenza | Infections and infestations | Transitioned to LOU064 25 mg b.i.d. | 4 | 129 | |
| other | Nasopharyngitis | Infections and infestations | LOU064 25 mg b.i.d. | 33 | 297 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 9 | 153 | |
| other | Nasopharyngitis | Infections and infestations | Transitioned to LOU064 25 mg b.i.d. | 3 | 129 | |
| other | Sinusitis | Infections and infestations | LOU064 25 mg b.i.d. | 5 | 297 |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LOU064 25 mg b.i.d. | 0 | 297 |
| Total, all-cause mortality | Placebo | 0 | 153 |
| Total, all-cause mortality | Transitioned to LOU064 25 mg b.i.d. | 0 | 129 |
| Total, other adverse events | LOU064 25 mg b.i.d. | 157 | 297 |
| Total, other adverse events | Placebo | 66 | 153 |
| Total, other adverse events | Transitioned to LOU064 25 mg b.i.d. | 40 | 129 |
| Total, serious adverse events | LOU064 25 mg b.i.d. | 12 | 297 |
| Total, serious adverse events | Placebo | 6 | 153 |
| Total, serious adverse events | Transitioned to LOU064 25 mg b.i.d. | 2 | 129 |
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 25 mg b.i.d. vs Placebo: Number of Participants Who Achieved Early Onset of Disease Activity Control (UAS7 =< 6) at Week 2 | Trial comparisons |
| LOU064 25 mg b.i.d. vs Placebo: Number of Participants Who Achieved Dermatology Life Quality Index (DLQI) = 0-1 at Week 12 | Trial comparisons |
| LOU064 25 mg b.i.d. vs Placebo: Number of Participants Who Achieved Complete Absence of Hives and Itch (UAS7 = 0) at Week 12 | Trial comparisons |
| LOU064 25 mg b.i.d. vs Placebo: Number of Participants Who Achieved Disease Activity Control (UAS7 =< 6) at Week 12 | 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/NCT05032157
GET https://conductscience.org/api/trials/v1/NCT05032157/results?page=2