Phase 3
Completed N=301
Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).
Source: ClinicalTrials.gov NCT03526861 ↗Enrolled (actual)
301
Serious AEs
2.3%
Results posted
Oct 2021
Primary outcomePrimary: Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 — 17; 21; 4 Participants — p=0.002
◆ Published Evidence
Highly cited
134citations · ~45 / year
Efficacy and Safety of Tralokinumab in Adolescents With Moderate to Severe Atopic Dermatitis: The Phase 3 ECZTRA 6 Randomized Clinical Trial.
Summary
Primary objective:
To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.
Secondary objectives:
To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health-related quality of life compared with placebo.
To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.
Linked Publications (5)
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Efficacy and Safety of Tralokinumab in Adolescents With Moderate to Severe Atopic Dermatitis: The Phase 3 ECZTRA 6 Randomized Clinical Trial.
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Population Pharmacokinetics of Tralokinumab in Adult Subjects With Moderate to Severe Atopic Dermatitis.
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Clinically Meaningful Improvements in Adolescents with Moderate-to-Severe Atopic Dermatitis Treated with Tralokinumab who did not Achieve Clear or Almost Clear Skin at Week 16.
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Effect of tralokinumab on moderate-to-severe atopic dermatitis in patients with atopic comorbidities.
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Clinical Laboratory Parameters in Adolescents with Moderate-to-Severe Atopic Dermatitis Treated with Tralokinumab Up to Week 52 in the Phase 3 ECZTRA 6 Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 |
17; 21; 4 | 0.002 sig |
| PRIMARY Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16 |
27; 28; 6 | <0.001 sig |
| SECONDARY Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16 |
24; 22; 3 | <0.001 sig |
| SECONDARY Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16 |
-29.1; -27.5; -9.5 | <0.001 sig |
| SECONDARY Change in Children's Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16 |
-6.7; -6.1; -4.1 | 0.007 sig |
| SECONDARY Number of Adverse Events |
130; 175; 134 | — |
| SECONDARY Presence of Anti-drug Antibodies |
1; 7; 2 | — |
| SECONDARY Subjects With at Least 50% Reduction in Eczema Area and Severity Index (EASI50) at Week 16. |
50; 45; 13 | <0.001 sig |
| SECONDARY Subjects With at Least 90% Reduction in Eczema Area and Severity Index (EASI90) at Week 16. |
17; 19; 4 | 0.002 sig |
| SECONDARY Change in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16 |
-18.1; -18.1; -8.7 | <0.001 sig |
| SECONDARY Subjects With at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD75) at Week 16 |
12; 16; 1 | 0.002 sig |
| SECONDARY Subjects With at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD50) at Week 16 |
30; 30; 5 | <0.001 sig |
| SECONDARY Change in Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) From Baseline to Week 16 |
-3.0; -2.7; -1.5 | <0.001 sig |
| SECONDARY Participants With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 3 From Baseline to Week 16 |
28; 29; 8 | <0.001 sig |
| SECONDARY Change in Patient Oriented Eczema Measure (POEM) From Baseline to Week 16 |
-8.4; -7.8; -2.4 | <0.001 sig |
| SECONDARY Tralokinumab Serum Trough Concentration at Week 16 |
105.7; 56.4 | — |
| SECONDARY Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16 |
3; 7; 6; 6 | — |
| SECONDARY Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 52 Among Subjects With at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16 |
4; 7; 7; 7 | — |
| SECONDARY Tralokinumab Serum Trough Concentration at Week 66 |
5.9; 1.0; 1.5; 2.6; 4.4 | — |
Eligibility Criteria
Inclusion Criteria
- Age 12 to 17.
- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
- History of AD for ≥1 year.
- History of topical corticosteroid (TCS; Europe: Class 3 or higher; US: Class 4 or lower) and/or topical calcineurin inhibitor (TCI) treatment failure or subjects for whom these topical AD treatments are medically inadvisable.
- 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
- 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, 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.
- 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 (NCT03526861) 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.