Atopic Dermatitis MedDRA version: 20.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 12 to 17. • Diagnosis of atopic dermatitis (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. Are the trial subjects under 18? yes Number of subjects for this age range: 294 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of subcutaneous administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe atopic dermatitis. ;Secondary Objective: To evaluate the efficacy of tralokinumab on severity and extent of atopic dermatitis, itch, and health-related quality of life compared with placebo. To investigate the safety, immunogenicity, and tolerability of subcutaneous administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to <18 years) with moderate-to-severe atopic dermatitis.;Primary end point(s): • Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 16 • At least 75% reduction in Eczema Area and Severity Index (EASI75) at Week 16 ;Timepoint(s) of evaluation of this end point: Bi-weekly from baseline until Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Severity and extent of AD: • Change in Scoring Atopic Dermatitis (SCORAD) from baseline to Week 16 Itch: • Reduction of Adolescent Pruritus numeric rating scale (NRS) (weekly average) of at least 4 from baseline to Week 16 Health-related quality of life: • Change in Children’s Dermatology Life Quality Index (CDLQI) score from baseline to Week 16 Safety • Number of adverse events. • Presence of anti-drug antibodies (yes/no). ;Timepoint(s) of evaluation of this end point: Bi-weekly from baseline to Week 52 for assessments conducted by the HCP. For Pruritus the assessment is done on a daily basis using an eDiary. For DLQI completed by the subject every 2, 4 or 8 weeks. | — |
Countries
Australia, Belgium, Canada, France, Germany, Japan, Netherlands, Poland, United Kingdom, United States
Contacts
Public ContactStine Kihl-Plambek
LEO Pharma A/S
Outcome results
None listed