Trial reportAmerican journal of clinical dermatology2026
Efficacy and Safety of Tralokinumab Across Racial Subgroups in Adults with Moderate-to-Severe Atopic Dermatitis: Post Hoc Analysis of Phase III Trials.
Trial report in American journal of clinical dermatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Monotherapy in Subjects With Moderate to Severe Atopic Dermatitis Who Are Candidates for Systemic Therapy
A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Monotherapy in Subjects With Moderate to Severe Atopic Dermatitis Who Are Candidates for Systemic Therapy
A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Subjects With Moderate to Severe Atopic Dermatitis
An Open-label, Single-arm, Multi-centre, Long-term Extension Trial to Evaluate the Safety and Efficacy of Tralokinumab in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Clinical Trials
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Effectiveness of Systemic Treatments for Atopic Dermatitis in the Head-and-Neck-Area: A Systematic Review and Meta-analysis.American journal of clinical dermatology · 2026Pooled it
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDifferences in atopic dermatitis (AD) prevalence, clinical presentation, and pathophysiology have been reported in different ethnic/racial groups; however, clinical trial data for patients with skin of color are limited. Tralokinumab is a monoclonal antibody that specifically targets interleukin-13, a key driver of AD.
objectivesTo investigate the efficacy and safety of tralokinumab, and examine AD biomarker expression at baseline and week 16, by self-reported racial subgroup (Asian, Black, and White) in patients with moderate-to-severe AD.
methodsPost hoc analyses were conducted by racial subgroup using data from four phase 3 trials: placebo-controlled parent trials ECZTRA 1, 2, and 3 and the open-label extension trial ECZTEND. Endpoints included Investigator's Global Assessment (IGA) 0/1, 75% improvement in Eczema Area and Severity Index (EASI-75), and adverse events. In ECZTRA 1, serum and skin samples were analyzed for biomarker expression by immunoassay and Staphylococcus aureus (S. aureus) abundance by quantitative polymerase chain reaction (qPCR).
resultsA total of 1876 patients pooled from ECZTRA 1/2/3 (Asian/Black/White N = 407/134/1335) and 1392 patients from ECZTEND (Asian/Black/White N = 203/108/1081) were included. Baseline characteristics were largely balanced between treatment groups and racial subgroups, although AD severity was more moderate in Black patients and regional differences were observed. At week 16 of ECZTRA 1/2/3, tralokinumab improved efficacy outcomes, including IGA 0/1 and EASI-75, relative to placebo across all subgroups. Further improvements beyond week 16 were observed with continued tralokinumab treatment, including 78%, 88%, and 83% of Asian, Black, and White patients, respectively, achieving EASI-75 at week 56 of ECZTEND (corresponding to up to 2 years total tralokinumab treatment). At baseline, serum biomarker levels were elevated in Asian patients from Japan compared with other subgroups, while Asian patients from USA/Europe had lower S. aureus abundance, when adjusting for IGA. The safety profile of tralokinumab was comparable to placebo, and serious adverse events and adverse events leading to treatment discontinuation were rare, across racial subgroups.
conclusionsTralokinumab was well-tolerated and improved signs, symptoms, and biomarkers in patients with moderate-to-severe AD at 16 weeks across the racial subgroups studied, with further improvement in response rates up to 2 years of treatment. CLINICAL
trial registrationClinicalTrials.gov identifiers: NCT03131648 (registered 24 April 2017), NCT03160885 (registered 18 May 2017), NCT03363854 (registered 01 December 2017), and NCT03587805 (registered 03 July 2018).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.