Safety and Tolerability of LEO 138559 in Healthy Subjects and Subjects With Atopic Dermatitis

Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEO 138559 in Healthy Subjects and Subjects With Moderate to Severe Atopic Dermatitis

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03514511

Enrollment

Registered

2018-05-02

Start date

2018-05-07

Completion date

2021-03-02

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

The primary objective of this trial is to investigate the safety and tolerability of LEO 138559 in healthy subjects and subjects with moderate to severe atopic dermatitis. The secondary objective of this trial is to study the pharmacokinetics and pharmacodynamics following administration of LEO 138559 to healthy subjects and subjects with moderate to severe atopic dermatitis. Healthy subjects will be exposed to 7 different dose regimens of LEO 138559 (one dose regimen per subject). Subjects with moderate to severe atopic dermatitis will be exposed to 2 different dose regimens of LEO 138559 (one dose regimen per subject).

Interventions

DRUGLEO 138559

LEO 138559 is a compound in development at LEO Pharma A/S

DRUGLEO 138559 placebo

LEO 138559 placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

For healthy subjects and subjects with atopic dermatitis: * Males and females without childbearing potential. * Age between 18 and 55, inclusive. * Body mass index between 18 and 32 kg/m2, inclusive. * Healthy apart from atopic dermatitis for the subjects presenting the disease. For subjects with atopic dermatitis only: * History of atopic dermatitis for more than 6 months. * Female subjects with childbearing potential and male subjects with female partners with childbearing potential using highly effective contraception from start of the trial and until a period after the last administered dose of trial drug.

Exclusion criteria

For healthy subjects and subjects with atopic dermatitis: * Any significant disease detected prior to enrolment. * Subjects who are still participating in a clinical trial or who have participated in a clinical trial within 3 months prior to enrolment or within 5 times of the half-life of the experimental therapy, whichever is longer. * Skin diseases that may interfere with the diagnosis of atopic dermatitis or assessment of the treatment. * Use of tanning beds or phototherapy within 6 weeks prior to enrolment. * Subjects with atopic dermatitis requiring more than 3 bleach baths from 4 weeks prior to screening until end of trial. * Blood pressure or pulse rate outside of the normal range. For subjects with atopic dermatitis only: * Initiation of treatment of atopic dermatitis with prescription emollients during the screening period.

Design outcomes

Primary

Measure	Time frame
Safety of LEO 138559 - numbers of subjects with adverse events	Day 1 to Day 120
Safety of LEO 138559 - number of adverse events	Day 1 to Day 120
Tolerability of LEO 138559 - number of local site reactions	Day 1 to Day 120

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026