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
1 other identifier
interventional
47
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2018
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2018
CompletedFirst Posted
Study publicly available on registry
May 2, 2018
CompletedStudy Start
First participant enrolled
May 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2021
CompletedFebruary 24, 2025
March 1, 2021
2.8 years
April 11, 2018
February 21, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (9)
Cohort 1 in healthy subjects
EXPERIMENTALLEO 138559 (dose regiment 1) or LEO 138559 placebo
Cohort 2 in healthy subjects
EXPERIMENTALLEO 138559 (dose regiment 2) or LEO 138559 placebo
Cohort 3 in healthy subjects
EXPERIMENTALLEO 138559 (dose regiment 3) or LEO 138559 placebo
Cohort 4 in healthy subjects
EXPERIMENTALLEO 138559 (dose regiment 4) or LEO 138559 placebo
Cohort 5 in healthy subjects
EXPERIMENTALLEO 138559 (dose regiment 5) or LEO 138559 placebo
Cohort 6 in healthy subjects
EXPERIMENTALLEO 138559 (dose regiment 6) or LEO 138559 placebo
Cohort 7 in healthy subjects
EXPERIMENTALLEO 138559 (dose regiment 7) or LEO 138559 placebo
Cohort 8 in subjects with atopic dermatitis
EXPERIMENTALLEO 138559 (dose regiment 8) or LEO 138559 placebo
Cohort 9 in subjects with atopic dermatitis
EXPERIMENTALLEO 138559 (dose regiment 9) or LEO 138559 placebo
Interventions
LEO 138559 is a compound in development at LEO Pharma A/S
LEO 138559 placebo
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
Study Sites (3)
Investigational site
Leeds, United Kingdom
Investigational site
Liverpool, United Kingdom
LEO Pharma investigational site
Manchester, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
LEO Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2018
First Posted
May 2, 2018
Study Start
May 7, 2018
Primary Completion
March 2, 2021
Study Completion
March 2, 2021
Last Updated
February 24, 2025
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share