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Comparison · NCT03131648-8552b7d2

Tralokinumab 300 mg Q2W vs Placebo Q2W: Subjects 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

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ConductScience Library. Tralokinumab 300 mg Q2W vs Placebo Q2W: Subjects Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 16. Trial comparisons, record NCT03131648-8552b7d2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03131648-8552b7d2

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.250.2170.286wilson
Risk in group 20.1270.08750.181wilson
Risk difference, group 1 minus group 20.1230.05970.176newcombe hybrid score
Risk ratio, group 1 over group 21.971.332.91log
Odds ratio, group 1 over group 22.291.453.62log
Number needed to treat, for one more participant with the outcome on Tralokinumab 300 mg Q2W than on Placebo Q2W8.155.6816.8from the risk difference interval

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Tralokinumab 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.
150601OG000
Group 2Placebo 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.
25197OG001

Outcome

Type
PRIMARY
Title
Subjects 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 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

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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