Comparison · NCT03131648-96760dfa
Tralokinumab 300 mg Q2W vs Placebo Q2W: Reduction of Worst Daily Pruritus NRS (Weekly Average) ≥3 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
Cite this record
ConductScience Library. Tralokinumab 300 mg Q2W vs Placebo Q2W: Reduction of Worst Daily Pruritus NRS (Weekly Average) ≥3 From Baseline to Week 16. Trial comparisons, record NCT03131648-96760dfa. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03131648-96760dfa
On this page
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 | 0.296 | 0.261 | 0.334 | wilson | |
| Risk in group 2 | 0.144 | 0.101 | 0.2 | wilson | |
| Risk difference, group 1 minus group 2 | 0.153 | 0.0866 | 0.21 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.06 | 1.43 | 2.97 | log | |
| Odds ratio, group 1 over group 2 | 2.51 | 1.62 | 3.89 | log | |
| Number needed to treat, for one more participant with the outcome on Tralokinumab 300 mg Q2W than on Placebo Q2W | 6.54 | 4.77 | 11.5 | 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. | 177 | 597 | 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. | 28 | 195 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Reduction of Worst Daily Pruritus NRS (Weekly Average) ≥3 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. Number of subjects analysed = subjects with baseline Pruritus NRS weekly average of at least 3
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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03131648-96760dfa