Comparison · NCT03562377-be0db302
Tralokinumab vs Placebo: Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16.
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. Tralokinumab vs Placebo: Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16. Trial comparisons, record NCT03562377-be0db302. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03562377-be0db302
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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 | 0.491 | 0.397 | 0.584 | wilson | |
| Risk in group 2 | 0.361 | 0.277 | 0.455 | wilson | |
| Risk difference, group 1 minus group 2 | 0.129 | -0.00283 | 0.256 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.36 | 0.989 | 1.87 | log | |
| Odds ratio, group 1 over group 2 | 1.7 | 0.986 | 2.94 | log | |
| Number needed to treat, for one more participant with the outcome on Tralokinumab than on Placebo | 7.72 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Tralokinumab | Participants received tralokinumab every 2 weeks for 16 weeks, and the Tdap and meningococcal vaccines at Week 12. | 52 | 106 | OG000 |
| Group 2 | Placebo | Participants received placebo every 2 weeks for 16 weeks, and the Tdap and meningococcal vaccines at Week 12. | 39 | 108 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16.
- Description
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis.~\> The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
- Time frame
- Week 0 to Week 16
- Population
The analysis of the secondary outcome measures was done for the full analysis set, i.e. all participants who were randomised and exposed to IMP (tralokinumab/placebo). 1 participant in the tralokinumab group was randomised in error and not exposed to IMP and therefore excluded from the full analysis set.
Source ClinicalTrials.gov
Trial
- Title
- Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5)
- NCT number
- NCT03562377
- Phases
- PHASE2
- Conditions
- Atopic Dermatitis
- Interventions
- Tralokinumab, Placebo, Tdap vaccine, Meningococcal vaccine
- Lead sponsor
- LEO Pharma
- Results first posted
- 2021-03-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03562377?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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