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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514511
• Other study ID #: LP0145-1315
• Status: Completed
• Phase: Phase 1
• Start date: May 7, 2018
• Est. completion date: March 2, 2021

Study information

• Verified date: March 2021
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 2, 2021
• Est. primary completion date: March 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• LEO 138559
LEO 138559 is a compound in development at LEO Pharma A/S
• LEO 138559 placebo
LEO 138559 placebo

Locations

Country	Name	City	State
United Kingdom	Investigational site	Leeds
United Kingdom	Investigational site	Liverpool
United Kingdom	LEO Pharma investigational site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

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