Comparison · NCT03131648-2c7691c3
Tralokinumab 300 mg Q2W vs Placebo Q2W: Subjects Achieving at Least 90% 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 300 mg Q2W vs Placebo Q2W: Subjects Achieving at Least 90% Reduction in Eczema Area and Severity Index [EASI] at Week 16. Trial comparisons, record NCT03131648-2c7691c3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03131648-2c7691c3
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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 | 0.145 | 0.119 | 0.175 | wilson | |
| Risk in group 2 | 0.0406 | 0.0207 | 0.0781 | wilson | |
| Risk difference, group 1 minus group 2 | 0.104 | 0.0586 | 0.14 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.56 | 1.76 | 7.22 | log | |
| Odds ratio, group 1 over group 2 | 4 | 1.9 | 8.41 | log | |
| Number needed to treat, for one more participant with the outcome on Tralokinumab 300 mg Q2W than on Placebo Q2W | 9.6 | 7.12 | 17.1 | 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 | Tralokinumab 300 mg Q2W | Week 0 to Week 16:~Tralokinumab 300 mg Q2W~At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab. | 87 | 601 | OG000 |
| Group 2 | Placebo Q2W | Week 0 to Week 16:~Placebo Q2W.~At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo. | 8 | 197 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Subjects Achieving at Least 90% 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 AD. 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
- At Week 16
- Population
- Full analysis set
Source ClinicalTrials.gov
Trial
- Title
- Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1)
- NCT number
- NCT03131648
- Phases
- PHASE3
- Conditions
- Atopic Dermatitis
- Interventions
- Tralokinumab, Placebo
- Lead sponsor
- LEO Pharma
- Results first posted
- 2020-11-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03131648?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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