Comparison · NCT05030311-7c8447fa
LOU064 25mg b.i.d. vs Placebo: Number of Patients With Early Onset of Disease Control (UAS7 ≤ 6 at Week 2)
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 25mg b.i.d. vs Placebo: Number of Patients With Early Onset of Disease Control (UAS7 ≤ 6 at Week 2). Trial comparisons, record NCT05030311-7c8447fa. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05030311-7c8447fa
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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 | 0.337 | 0.286 | 0.391 | wilson | |
| Risk in group 2 | 0.0327 | 0.014 | 0.0742 | wilson | |
| Risk difference, group 1 minus group 2 | 0.304 | 0.239 | 0.361 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 10.3 | 4.29 | 24.7 | log | |
| Odds ratio, group 1 over group 2 | 15 | 5.97 | 37.8 | log | |
| Number needed to treat, for one more participant with the outcome on LOU064 25mg b.i.d. than on Placebo | 3.29 | 2.77 | 4.19 | 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 25mg 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) | 104 | 309 | OG000 |
| Group 2 | Placebo | Patients initially randomized to Placebo (Up to Week 24) | 5 | 153 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Patients With Early Onset of Disease Control (UAS7 ≤ 6 at Week 2)
- Description
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).
- Time frame
- Week 2
- 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
- NCT05030311
- Phases
- PHASE3
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- LOU064 25 mg (b.i.d), Placebo, LOU064 25 mg (b.i.d) as a tablet.
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2024-12-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05030311?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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