Comparison · NCT03131648-cc39c7ac
Tralokinumab 300 mg Q2W vs Placebo Q2W: Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of ≥4 Points Among Subjects With Baseline DLQI ≥4
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 From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of ≥4 Points Among Subjects With Baseline DLQI ≥4. Trial comparisons, record NCT03131648-cc39c7ac. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03131648-cc39c7ac
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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 | 0.446 | 0.406 | 0.487 | wilson | |
| Risk in group 2 | 0.316 | 0.254 | 0.385 | wilson | |
| Risk difference, group 1 minus group 2 | 0.131 | 0.0506 | 0.205 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.41 | 1.13 | 1.78 | log | |
| Odds ratio, group 1 over group 2 | 1.75 | 1.23 | 2.47 | log | |
| Number needed to treat, for one more participant with the outcome on Tralokinumab 300 mg Q2W than on Placebo Q2W | 7.66 | 4.89 | 19.7 | 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. | 258 | 578 | 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. | 60 | 190 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of ≥4 Points Among Subjects With Baseline DLQI ≥4
- Description
The DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their QoL over the last week such as dermatology related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL.
- Time frame
- Week 0 to Week 16
- Population
- Full analysis set. Number of subjects analysed = subjects with baseline DLQI ≥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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