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 18 and above. * Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD. * History of AD for =1 year. * AD involvement of =10% body surface area at screening and baseline according to component A of SCORAD. * Subjects who have a recent history (within 1 year before the screening visit) of inadequate response to treatment with topical medications. *Documented history of either no previous CSA exposure and not currently a candidate for CSA treatment OR previous exposure to CSA in which case CSA treatment should not be continued or restarted. *Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: * Subjects for whom TCSs are medically inadvisable e.g., due to important side effects or safety risks * 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 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 demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating severe Atopic Dermatitis (AD) in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA).;Primary end point(s): At least 75 percent reduction in EASI score (EASI75);Timepoint(s) of evaluation of this end point: Week 16;Secondary Objective: * To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared to placebo in combination with TCS. * To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in subjects who are not adequately controlled with or have contraindications to oral CSA compared to placebo in combination with TCS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Severity and extent of AD * IGA score of 0 (clear) or 1 (almost clear) * Change in SCORAD from baseline * EASI75 Itch Reduction of Worst Daily Pruritus NRS4 (weekly average) of at least 4 Health-related quality of life * Change in DLQI score from baseline to Week 16 Number of adverse events Presence of anti-drug antibodies ;Timepoint(s) of evaluation of this end point: Week 16 and Week 26, respectively | — |
Countries
Belgium, Czech Republic, France, Germany, Spain, United Kingdom
Contacts
Public ContactTine Drejer
Leo Pharma A/S
Outcome results
None listed