COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514511
Recruitment Status : Active, not recruiting
First Posted : May 2, 2018
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Tracking Information
First Submitted Date  ICMJE April 11, 2018
First Posted Date  ICMJE May 2, 2018
Last Update Posted Date January 11, 2021
Actual Study Start Date  ICMJE May 7, 2018
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
  • Safety of LEO 138559 - numbers of subjects with adverse events [ Time Frame: Day 1 to Day 120 ]
  • Safety of LEO 138559 - number of adverse events [ Time Frame: Day 1 to Day 120 ]
  • Tolerability of LEO 138559 - number of local site reactions [ Time Frame: Day 1 to Day 120 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of LEO 138559 in Healthy Subjects and Subjects With Atopic Dermatitis
Official Title  ICMJE 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
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: LEO 138559
    LEO 138559 is a compound in development at LEO Pharma A/S
  • Drug: LEO 138559 placebo
    LEO 138559 placebo
Study Arms  ICMJE
  • Experimental: Cohort 1 in healthy subjects
    LEO 138559 (dose regiment 1) or LEO 138559 placebo
    Interventions:
    • Drug: LEO 138559
    • Drug: LEO 138559 placebo
  • Experimental: Cohort 2 in healthy subjects
    LEO 138559 (dose regiment 2) or LEO 138559 placebo
    Interventions:
    • Drug: LEO 138559
    • Drug: LEO 138559 placebo
  • Experimental: Cohort 3 in healthy subjects
    LEO 138559 (dose regiment 3) or LEO 138559 placebo
    Interventions:
    • Drug: LEO 138559
    • Drug: LEO 138559 placebo
  • Experimental: Cohort 4 in healthy subjects
    LEO 138559 (dose regiment 4) or LEO 138559 placebo
    Interventions:
    • Drug: LEO 138559
    • Drug: LEO 138559 placebo
  • Experimental: Cohort 5 in healthy subjects
    LEO 138559 (dose regiment 5) or LEO 138559 placebo
    Interventions:
    • Drug: LEO 138559
    • Drug: LEO 138559 placebo
  • Experimental: Cohort 6 in healthy subjects
    LEO 138559 (dose regiment 6) or LEO 138559 placebo
    Interventions:
    • Drug: LEO 138559
    • Drug: LEO 138559 placebo
  • Experimental: Cohort 7 in healthy subjects
    LEO 138559 (dose regiment 7) or LEO 138559 placebo
    Interventions:
    • Drug: LEO 138559
    • Drug: LEO 138559 placebo
  • Experimental: Cohort 8 in subjects with atopic dermatitis
    LEO 138559 (dose regiment 8) or LEO 138559 placebo
    Interventions:
    • Drug: LEO 138559
    • Drug: LEO 138559 placebo
  • Experimental: Cohort 9 in subjects with atopic dermatitis
    LEO 138559 (dose regiment 9) or LEO 138559 placebo
    Interventions:
    • Drug: LEO 138559
    • Drug: LEO 138559 placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 8, 2021)
47
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2018)
54
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03514511
Other Study ID Numbers  ICMJE LP0145-1315
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party LEO Pharma
Study Sponsor  ICMJE LEO Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director LEO Pharma
PRS Account LEO Pharma
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP