An evaluation of LEO 138559 in adults with moderate to severe atopic dermatitis
- Conditions
- Atopic Dermatitis (AD)MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2020-005541-16-DE
- Lead Sponsor
- EO Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 52
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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