Comparison · NCT05032157-526067e2
LOU064 25 mg b.i.d. vs Placebo: Number of Participants Who Achieved Dermatology Life Quality Index (DLQI) = 0-1 at Week 12
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 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, record NCT05032157-526067e2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05032157-526067e2
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.357 | 0.305 | 0.413 | wilson | |
| Risk in group 2 | 0.183 | 0.13 | 0.252 | wilson | |
| Risk difference, group 1 minus group 2 | 0.174 | 0.0875 | 0.251 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.95 | 1.35 | 2.82 | log | |
| Odds ratio, group 1 over group 2 | 2.48 | 1.54 | 3.98 | log | |
| Number needed to treat, for one more participant with the outcome on LOU064 25 mg b.i.d. than on Placebo | 5.75 | 3.98 | 11.4 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | LOU064 25 mg b.i.d. | Patients initially randomized to Remibrutinib during the Double-blind treatment period and continued Remibrutinib during the Open-label treatment period (Up to Week 52) | 106 | 297 | OG000 |
| Group 2 | Placebo | Patients initially randomized to Placebo during the Double-Blind treatment period (Up to Week 24) | 28 | 153 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Achieved Dermatology Life Quality Index (DLQI) = 0-1 at Week 12
- Description
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.
- Time frame
- Week 12
- Population
- Full Analysis Set (FAS)
Source ClinicalTrials.gov
Trial
- 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
- Phases
- PHASE3
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- LOU064 (blinded), Placebo, LOU064 (open-label)
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2024-11-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05032157?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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