Phase 3
Completed N=380
Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3
Source: ClinicalTrials.gov NCT03363854 ↗Enrolled (actual)
380
Serious AEs
1.5%
Results posted
Jan 2021
Primary outcomePrimary: Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 — 98; 33 Participants — p=0.015
◆ Published Evidence
Established
49citations · ~12 / year
Tralokinumab Plus Topical Corticosteroids as Needed Provides Progressive and Sustained Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Over a 32-Week Period: An ECZTRA 3 Post Hoc Analysis.
Summary
Primary objective:
To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD).
Secondary objectives:
To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared with placebo in combination with TCS.
To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 32 weeks.
Linked Publications (5)
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Tralokinumab Plus Topical Corticosteroids as Needed Provides Progressive and Sustained Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Over a 32-Week Period: An ECZTRA 3 Post Hoc Analysis.
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Tralokinumab Efficacy and Safety, with or without Topical Corticosteroids, in North American Adults with Moderate-to-Severe Atopic Dermatitis: A Subanalysis of Phase 3 Trials ECZTRA 1, 2, and 3.
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Efficacy and Safety of Tralokinumab Across Racial Subgroups in Adults with Moderate-to-Severe Atopic Dermatitis: Post Hoc Analysis of Phase III Trials.
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Cost-Per-Responder Analysis for Tralokinumab and Dupilumab in Combination with Topical Corticosteroids in Patients with Moderate-To-Severe Atopic Dermatitis.
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Effect of tralokinumab on moderate-to-severe atopic dermatitis in patients with atopic comorbidities.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 |
98; 33 | 0.015 sig |
| PRIMARY Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16 |
141; 45 | <0.001 sig |
| SECONDARY Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16 |
113; 43 | 0.037 sig |
| SECONDARY Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16 |
-37.7; -26.8 | <0.001 sig |
| SECONDARY Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16 |
-11.7; -8.8 | <0.001 sig |
| SECONDARY Frequency of Anti-drug Antibodies (ADA) |
2; 3; 0; 0; 0; 0 | — |
| SECONDARY Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes |
29.3; 32.8; 19.7; 26.6; 18.5; 23.2 | 0.41 |
| SECONDARY Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes |
40.1; 40.1; 32.4; 31.3; 29.2; 30.6 | 1.00 |
| SECONDARY Number of Atopic Dermatitis Flares Through Week 16 |
119; 75 | — |
| SECONDARY Number of Days Without Topical Treatment Use From Baseline to Week 16 |
2.6; 2.5; 3.0; 2.6; 2.9; 2.7 | 0.64 |
| SECONDARY Participants Achieving at Least 50% Reduction in Eczema Area and Severity Index (EASI) at Week 16 |
200; 73 | <0.001 sig |
| SECONDARY Participants Achieving at Least 90% Reduction in Eczema Area and Severity Index (EASI) at Week 16 |
83; 27 | 0.022 sig |
| SECONDARY Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score |
-21.0; -15.6 | <0.001 sig |
| SECONDARY Participants Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16 |
154; 48 | <0.001 sig |
| SECONDARY Participants Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16 |
60; 16 | 0.012 sig |
| SECONDARY Change From Baseline to Week 16 in Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) |
-4.1; -2.9 | <0.001 sig |
| SECONDARY Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of at Least 4 Points Among Participants With Baseline DLQI ≥4 |
207; 81 | <0.001 sig |
| SECONDARY Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 32 Among Participants With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab |
43; 38 | — |
| SECONDARY Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 32 Among Participants Who Had Achieved at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab |
62; 59 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 and above.
- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
- History of AD for ≥1 year.
- Subjects who have a recent history of inadequate response to treatment with topical medications.
- AD involvement of ≥10% body surface area at screening and baseline.
- Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.
Exclusion Criteria
- Subjects for whom TCS are medically inadvisable e.g., due to important side effects or safety risks in the opinion of the investigator.
- Active dermatologic conditions that may confound the diagnosis of AD.
- Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
- Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
- Treatment with TCS, topical calcineurin inhibitors (TCI), or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation.
- Receipt of any marketed biological therapy (i.e. immunoglobulin, anti- immunoglobulin E) including dupilumab or investigational biologic agents within 3 months or 5 half-lives, whichever is longer prior to randomisation.
- Active skin infection within 1 week prior to randomisation.
- Clinically significant infection within 4 weeks prior to randomisation.
- A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
- Tuberculosis requiring treatment within the 12 months prior to screening.
- Known primary immunodeficiency disorder.
Data sourced from ClinicalTrials.gov (NCT03363854) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.