Atopic Dermatitis
Conditions
Interventions
Week 0 to Week 16: Tralokinumab or placebo will be given as subcutaneous injections. Participants will receive tralokinumab or placebo loading dose on Day 0 followed by multiple tralokinumab or placeb
Sponsors
Kato Norito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Japanese subject aged 18 years and above. - Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD. - History of AD for 1 year or more. - A recent history (within 1 year before screening) of inadequate response to treatment with topical medication. - AD involvement of 10% or more body surface area at screening and at baseline according to component A of SCORAD. - Applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.
Exclusion criteria
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 or would interfere with assessment of treatment. - Use of tanning beds or phototherapy within 6 weeks prior to randomisation. - Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 4 weeks prior to randomisation. - Treatment with TCS, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or topical Janus kinase inhibitors within 2 weeks prior to randomisation. - Receipt of any marketed biological therapy (i.e. immunoglobulin, antiimmunoglobulin E) including dupilumab or investigational biologic agents 3 to 6 months prior to randomisation. - Active skin infections 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 |
|---|---|
| - Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) (IGA 0 or 1) at Week 16. - At least 75 % reduction in Eczema Area and Severity Index (EASI75) at Week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in Scoring Atopic Dermatitis (SCORAD) total score from baseline to Week 16. - Change in Dermatology Life Quality Index (DLQI) score from baseline to Week 16. - Reduction of Worst Daily Pruritus numeric rating scale (NRS) score (weekly average) more than or equal to 4 from baseline to Week 16. | — |
Contacts
Public ContactClinical Disclosure
LEO Pharma A/S
Outcome results
None listed