Atopic Dermatitis (AD) MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Product Name: LEO 138559 lyophilisate, for solution for injection (150 mg/mL)
Product Code: LEO 138559
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: Not Applicable
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 – 64 years old (both included) at baseline. Diagnosis of AD [as defined by the AAD Consensus Criteria] that has been present for =1 year prior to screening. Subjects who have a recent history (within 6 months before screening) of inadequate response to treatment with topical medication, or for whom topical treatments are otherwise medically inadvisable. EASI score =12 at screening and =16 at baseline. vIGA-AD score =3 at screening and baseline. Body surface area (BSA) of AD involvement =10% at screening and baseline. Worst Daily Pruritus NRS (weekly average) of =3 points at baseline. 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 52 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Treatment with systemic immunosuppressive/immunomodulating medication, immunoglobulin/blood products, or phototherapy within 4 weeks or 5 half-lives prior to randomisation, whichever is longer. Treatment with biologics within 5 half-lives (if known) or 16 weeks prior to randomisation, whichever is longer. Treatment with TCS, TCI, topical PDE-4 inhibitor, or other topical prescription treatments within 1 week prior to randomisation. Treatment with a live (attenuated) vaccine within 12 weeks prior to randomisation. Clinically significant active chronic or acute infection requiring systemic treatment within 4 weeks prior to randomisation that may compromise the safety of the subject. Skin infection within 1 week prior to the baseline visit. Presence of hepatitis B or C infection at screening. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening. Subject has a positive test for tuberculosis at screening. Subject is pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To compare the safety of LEO 138559 with placebo in subjects with moderate to severe AD.;Primary end point(s): Change in Eczema Area and Severity Index (EASI) score from baseline to Week 16.;Timepoint(s) of evaluation of this end point: Week 16;Main Objective: To compare the efficacy of LEO 138559 with placebo in subjects with moderate to severe AD. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of treatment-emergent adverse events from baseline to Week 16 per subject.;Timepoint(s) of evaluation of this end point: Week 16 | — |
Countries
Canada, Germany, Poland, United States
Contacts
Public ContactGlobal Regulatory Affairs
LEO Pharma A/S
Outcome results
None listed