Phase 2
Completed N=204
Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis
Source: ClinicalTrials.gov NCT02347176 ↗Enrolled (actual)
204
Serious AEs
2.9%
Results posted
Jun 2017
Primary outcomePrimary: Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12 — -10.78; -13.67; -15.14; -15.72 units on a scale — p=0.143
Summary
The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with atopic dermatitis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12 |
-10.78; -13.67; -15.14; -15.72 | 0.143 |
| PRIMARY Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12 |
11.8; 11.6; 19.5; 26.7 | 0.974 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
31; 36; 35; 30; 1; 3 | — |
| SECONDARY Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events |
0; 1; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events |
0; 1; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events |
0; 0; 0; 0 | — |
| SECONDARY Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12 |
51.9; 54.3; 67.3; 73.4 | — |
| SECONDARY Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12 |
-16.67; -21.97; -26.09; -26.50 | — |
| SECONDARY Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12 |
19.5; 26.9; 44.2; 44.1 | — |
| SECONDARY Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12 |
-1.03; -1.80; -1.59; -2.17 | — |
Eligibility Criteria
Inclusion Criteria
- Physician diagnosis of atopic dermatitis for greater than (>) 1 year
- Atopic dermatitis involvement of greater than or equal to (>=) 10 percent (%) body surface area
- EASI score of >= 12
- SCORAD of >= 25
- IGA score of >= 3
- Effective birth control in line with protocol details
Exclusion Criteria
- History of anaphylaxis following any biologic therapy
- Hepatitis B, C or human immunodeficiency virus
- Pregnant or breastfeeding
- History of cancer
- Previous receipt of tralokinumab
Data sourced from ClinicalTrials.gov (NCT02347176). 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.