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Trial record 89 of 154 for:    Dermatitis, Atopic, 8

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

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ClinicalTrials.gov Identifier: NCT03514511
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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).


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: LEO 138559 Drug: LEO 138559 placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514511


Contacts
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Contact: LEO Pharma A/S (+1) 877-557-1168 disclosure@leo-pharma.com

Locations
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United Kingdom
Investigational site Recruiting
Leeds, United Kingdom
Investigational site Recruiting
Liverpool, United Kingdom
LEO Pharma investigational site Recruiting
Manchester, United Kingdom
Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Study Director LEO Pharma

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03514511     History of Changes
Other Study ID Numbers: LP0145-1315
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases