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CompletedNCT03514511Updated Feb 24, 2025

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

A Phase 1 interventional study of LEO 138559 and LEO 138559 placebo in Atopic Dermatitis, sponsored by LEO Pharma. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by LEO Pharma · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Atopic Dermatitis
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 47 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

LEO Pharma is the lead sponsor of 221 studies on the registry; 5 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    Cohort 1 in healthy subjects

    LEO 138559 (dose regiment 1) or LEO 138559 placebo

    Drug: LEO 138559 · Drug: LEO 138559 placebo

  • Experimental
    Cohort 2 in healthy subjects

    LEO 138559 (dose regiment 2) or LEO 138559 placebo

    Drug: LEO 138559 · Drug: LEO 138559 placebo

  • Experimental
    Cohort 3 in healthy subjects

    LEO 138559 (dose regiment 3) or LEO 138559 placebo

    Drug: LEO 138559 · Drug: LEO 138559 placebo

  • Experimental
    Cohort 4 in healthy subjects

    LEO 138559 (dose regiment 4) or LEO 138559 placebo

    Drug: LEO 138559 · Drug: LEO 138559 placebo

  • Experimental
    Cohort 5 in healthy subjects

    LEO 138559 (dose regiment 5) or LEO 138559 placebo

    Drug: LEO 138559 · Drug: LEO 138559 placebo

  • Experimental
    Cohort 6 in healthy subjects

    LEO 138559 (dose regiment 6) or LEO 138559 placebo

    Drug: LEO 138559 · Drug: LEO 138559 placebo

  • Experimental
    Cohort 7 in healthy subjects

    LEO 138559 (dose regiment 7) or LEO 138559 placebo

    Drug: LEO 138559 · Drug: LEO 138559 placebo

  • Experimental
    Cohort 8 in subjects with atopic dermatitis

    LEO 138559 (dose regiment 8) or LEO 138559 placebo

    Drug: LEO 138559 · Drug: LEO 138559 placebo

  • Experimental
    Cohort 9 in subjects with atopic dermatitis

    LEO 138559 (dose regiment 9) or LEO 138559 placebo

    Drug: LEO 138559 · Drug: LEO 138559 placebo

Interventions

  • DrugLEO 138559

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

  • DrugLEO 138559 placebo

    LEO 138559 placebo

06

What researchers measure

Primary outcomes

  1. Safety of LEO 138559 - numbers of subjects with adverse events

    Time frame: Day 1 to Day 120

  2. Safety of LEO 138559 - number of adverse events

    Time frame: Day 1 to Day 120

  3. Tolerability of LEO 138559 - number of local site reactions

    Time frame: Day 1 to Day 120

07

Study locations

3 sites
  • Investigational site
    Leeds, United Kingdom
  • Investigational site
    Liverpool, United Kingdom
  • LEO Pharma investigational site
    Manchester, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03514511
Lead sponsor
LEO Pharma
Responsible party
Sponsor
First posted
May 2, 2018
Start date
May 7, 2018
Primary completion
Mar 2, 2021
Completion
Mar 2, 2021
Last update
Feb 24, 2025

Study contacts

Study Director
study director · LEO Pharma

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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