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

March 10, 2021 updated by: LEO Pharma

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leeds, United Kingdom
        • Investigational Site
      • Liverpool, United Kingdom
        • Investigational Site
      • Manchester, United Kingdom
        • LEO Pharma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 in healthy subjects
LEO 138559 (dose regiment 1) or LEO 138559 placebo
Drug: LEO 138559
LEO 138559 is a compound in development at LEO Pharma A/S
Drug: LEO 138559 placebo
LEO 138559 placebo
Experimental: Cohort 2 in healthy subjects
LEO 138559 (dose regiment 2) or LEO 138559 placebo
Drug: LEO 138559
LEO 138559 is a compound in development at LEO Pharma A/S
Drug: LEO 138559 placebo
LEO 138559 placebo
Experimental: Cohort 3 in healthy subjects
LEO 138559 (dose regiment 3) or LEO 138559 placebo
Drug: LEO 138559
LEO 138559 is a compound in development at LEO Pharma A/S
Drug: LEO 138559 placebo
LEO 138559 placebo
Experimental: Cohort 4 in healthy subjects
LEO 138559 (dose regiment 4) or LEO 138559 placebo
Drug: LEO 138559
LEO 138559 is a compound in development at LEO Pharma A/S
Drug: LEO 138559 placebo
LEO 138559 placebo
Experimental: Cohort 5 in healthy subjects
LEO 138559 (dose regiment 5) or LEO 138559 placebo
Drug: LEO 138559
LEO 138559 is a compound in development at LEO Pharma A/S
Drug: LEO 138559 placebo
LEO 138559 placebo
Experimental: Cohort 6 in healthy subjects
LEO 138559 (dose regiment 6) or LEO 138559 placebo
Drug: LEO 138559
LEO 138559 is a compound in development at LEO Pharma A/S
Drug: LEO 138559 placebo
LEO 138559 placebo
Experimental: Cohort 7 in healthy subjects
LEO 138559 (dose regiment 7) or LEO 138559 placebo
Drug: LEO 138559
LEO 138559 is a compound in development at LEO Pharma A/S
Drug: LEO 138559 placebo
LEO 138559 placebo
Experimental: Cohort 8 in subjects with atopic dermatitis
LEO 138559 (dose regiment 8) or LEO 138559 placebo
Drug: LEO 138559
LEO 138559 is a compound in development at LEO Pharma A/S
Drug: LEO 138559 placebo
LEO 138559 placebo
Experimental: Cohort 9 in subjects with atopic dermatitis
LEO 138559 (dose regiment 9) or LEO 138559 placebo
Drug: LEO 138559
LEO 138559 is a compound in development at LEO Pharma A/S
Drug: LEO 138559 placebo
LEO 138559 placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2018

Primary Completion (Actual)

March 2, 2021

Study Completion (Actual)

March 2, 2021

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

May 1, 2018

First Posted (Actual)

May 2, 2018

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP0145-1315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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