Comparison · NCT03131648-3f6ec2df
Tralokinumab 300 mg Q2W vs Placebo Q2W: Reduction of Worst Daily Pruritus Numeric Rating Scale (Weekly Average) of at Least 4 From Baseline to Week 16.
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. Tralokinumab 300 mg Q2W vs Placebo Q2W: Reduction of Worst Daily Pruritus Numeric Rating Scale (Weekly Average) of at Least 4 From Baseline to Week 16. Trial comparisons, record NCT03131648-3f6ec2df. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03131648-3f6ec2df
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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 | 0.2 | 0.17 | 0.234 | wilson | |
| Risk in group 2 | 0.103 | 0.0677 | 0.154 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0972 | 0.0382 | 0.146 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.94 | 1.25 | 3.03 | log | |
| Odds ratio, group 1 over group 2 | 2.18 | 1.32 | 3.61 | log | |
| Number needed to treat, for one more participant with the outcome on Tralokinumab 300 mg Q2W than on Placebo Q2W | 10.3 | 6.83 | 26.2 | 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. | 119 | 594 | 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. | 20 | 194 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Reduction of Worst Daily Pruritus Numeric Rating Scale (Weekly Average) of at Least 4 From Baseline to Week 16.
- Description
- Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.
- Time frame
- Week 0 to Week 16
- Population
- Full analysis set (FAS). Number of subjects analysed = subjects with baseline pruritus NRS weekly average ≥4.
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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