Comparison · NCT02446899-dcb1e646
Anifrolumab 300 mg vs Placebo: Number of Participants With a ≥50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12 in The Sub-Group of Participants With Baseline CLASI Activity Score of ≥10
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Anifrolumab 300 mg vs Placebo: Number of Participants With a ≥50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12 in The Sub-Group of Participants With Baseline CLASI Activity Score of ≥10. Trial comparisons, record NCT02446899-dcb1e646. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02446899-dcb1e646
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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 | 0.49 | 0.356 | 0.625 | wilson | |
| Risk in group 2 | 0.25 | 0.142 | 0.402 | wilson | |
| Risk difference, group 1 minus group 2 | 0.24 | 0.0372 | 0.413 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.96 | 1.07 | 3.6 | log | |
| Odds ratio, group 1 over group 2 | 2.88 | 1.16 | 7.15 | log | |
| Number needed to treat, for one more participant with the outcome on Anifrolumab 300 mg than on Placebo | 4.17 | 2.42 | 26.9 | 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 | Anifrolumab 300 mg | Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). | 24 | 49 | OG000 |
| Group 2 | Placebo | Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). | 10 | 40 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
Number of Participants With a ≥50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12 in The Sub-Group of Participants With Baseline CLASI Activity Score of ≥10
- Description
50% reduction in CLASI activity score compared to baseline was defined by meeting all of the following criteria:~* Achieve ≥50% reduction of CLASI activity score at Week 12 compared to baseline~* No discontinuation of investigational product~* No use of restricted medications beyond the protocol allowed threshold before assessment
- Time frame
- Baseline; Week 12
- Population
- Full Analysis Set: All participants who were randomized and received at least one dose of study drug, and who had a CLASI activity score of ≥10 at baseline.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
- NCT number
- NCT02446899
- Phases
- PHASE3
- Conditions
- Active Systemic Lupus Erythematosus
- Interventions
- Anifrolumab, Placebo
- Lead sponsor
- AstraZeneca
- Results first posted
- 2020-03-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02446899?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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