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Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamic Effect of Different Concentrations of a New Anti-inflammatory Substance in Subjects With Chronic Plaque Psoriasis

Primary Purpose

Psoriasis Vulgaris

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
LEO 134310
LEO 134310
LEO 134310
LEO 134310
LEO 134310 vehicle
0.1% betamethasone valerate ointment (class III steroid)
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects aged 18-64 years (inclusive) with plaque psoriasis in a chronic stable phase.
  • Men or women of non-child bearing potential.

Exclusion Criteria:

  • Acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, pustular, exfoliative or inverse psoriasis.
  • According to defined washout periods: topical antipsoriatic drugs (except salicylic acid in petroleum jelly); systemic antipsoriatics and biologics; ultraviolet (UV) therapy.

Sites / Locations

  • Investigational Site
  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

LEO 134310 Dose A

LEO 134310 Dose B

LEO 134310 Dose C

LEO 134310 Dose D

LEO 134310 vehicle

0.1% betamethasone valerate ointment (class III steroid)

Arm Description

Once daily application

Once daily application

Once daily application

Once daily application

Once daily application

Once daily application

Outcomes

Primary Outcome Measures

Overall number of treatment-emergent adverse events.
Number of treatment-emergent application site reactions, by treatment.
Change from baseline to Day 4, Day 8 and Day 12 in haematology parameters
red blood cells, white blood cells, hemoglobin, hematocrit, MCH, MMCV, MCHC, platelets, white cell differentials, measure in SI units
Change from baseline to Day 4, Day 8 and Day 12 in clinical chemistry parameters
sodium, potassium, chloride, bicarbonate, blood urea nitrogen, glucose, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gammaGT, uric acid, calcium, phosphate, albumin, triglycerides, cholesterol, lactate dehydrogenase, total protein, creatinine, total bilirubin, direct bilirubin, indirect bilirubin
Change from baseline to Day 4, Day 8 and Day 12 in urinalysis parameters
Single parameters only to be listed if deviation from usual urine dip test, e.g., sediment, leucocytes, nitrite, pH, protein, glucose, ketones, urobilinogen, bilirubin, blood/haemoglobin
Number of subjects with abnormal clinical significant ECG evaluation
Evaluation of 12-lead ECG (overall evaluation, assessed by investigator as 'normal', 'abnormal not clinically significant', 'abnormal clinically significant')
Number of subjects with abnormal clinically significant findings of physical examination at Day 12.
Evaluation of physical examination (areas skin, heart, lung, abdomen, basic neurological status, general examination of eyes, ears, nose throat), overall evaluation, assessed by investigator as 'normal', 'abnormal not clinically significant', 'abnormal clinically significant'
Change from baseline to Day 4, Day 8, Day 12 in systolic and diastolic blood pressure.
measured in mmHg
Change from baseline to Day 4, Day 8 and Day 12 in pulse.
measured in beats per minute
Change from baseline to Day 4, Day 8 and Day 12 in oral body temperature.
measured in degrees celsius

Secondary Outcome Measures

Change from baseline to Day 4, Day 8 and Day 12 in psoriatic infiltrate thickness (assessed by measurement of the thickness of the Echo Poor Band [EPB] of the inflammatory infiltrate using 22-MHz sonography)
Change from baseline to Day 12 in disease severity
Clinical assessment of change in disease severity (a global assessment performed by an investigator using a 5-point score ('-1 = worsened', '0 = unchanged', '1 = slight improvement', '2 = clear improvement but not completely healed', '3 = completely healed')

Full Information

First Posted
August 23, 2018
Last Updated
February 5, 2019
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03669757
Brief Title
Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamic Effect of Different Concentrations of a New Anti-inflammatory Substance in Subjects With Chronic Plaque Psoriasis
Official Title
A Phase 1b, Randomised, Controlled, Observer-blinded Trial to Assess Safety, Tolerability and Pharmacodynamic Effects of LEO 134310 Cutaneous Solution in Descaled Skin of Adults With Chronic Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 27, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To assess safety and tolerability after treatment with LEO 134310 cutaneous solution.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Intra-individual comparison of all treatment
Masking
Investigator
Masking Description
The trial will be performed investigator-blind with random assignment of the 4 Investigational Medicinal Products (IMPs), the placebo and the active comparator.
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LEO 134310 Dose A
Arm Type
Experimental
Arm Description
Once daily application
Arm Title
LEO 134310 Dose B
Arm Type
Experimental
Arm Description
Once daily application
Arm Title
LEO 134310 Dose C
Arm Type
Experimental
Arm Description
Once daily application
Arm Title
LEO 134310 Dose D
Arm Type
Experimental
Arm Description
Once daily application
Arm Title
LEO 134310 vehicle
Arm Type
Placebo Comparator
Arm Description
Once daily application
Arm Title
0.1% betamethasone valerate ointment (class III steroid)
Arm Type
Active Comparator
Arm Description
Once daily application
Intervention Type
Drug
Intervention Name(s)
LEO 134310
Intervention Description
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
Intervention Type
Drug
Intervention Name(s)
LEO 134310
Intervention Description
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
Intervention Type
Drug
Intervention Name(s)
LEO 134310
Intervention Description
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
Intervention Type
Drug
Intervention Name(s)
LEO 134310
Intervention Description
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
Intervention Type
Drug
Intervention Name(s)
LEO 134310 vehicle
Intervention Description
Active substance: none
Intervention Type
Drug
Intervention Name(s)
0.1% betamethasone valerate ointment (class III steroid)
Intervention Description
Active substance: betamethasone valerate
Primary Outcome Measure Information:
Title
Overall number of treatment-emergent adverse events.
Time Frame
Up to Day 19
Title
Number of treatment-emergent application site reactions, by treatment.
Time Frame
Up to Day 19
Title
Change from baseline to Day 4, Day 8 and Day 12 in haematology parameters
Description
red blood cells, white blood cells, hemoglobin, hematocrit, MCH, MMCV, MCHC, platelets, white cell differentials, measure in SI units
Time Frame
Up to Day 12
Title
Change from baseline to Day 4, Day 8 and Day 12 in clinical chemistry parameters
Description
sodium, potassium, chloride, bicarbonate, blood urea nitrogen, glucose, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gammaGT, uric acid, calcium, phosphate, albumin, triglycerides, cholesterol, lactate dehydrogenase, total protein, creatinine, total bilirubin, direct bilirubin, indirect bilirubin
Time Frame
Up to Day 12
Title
Change from baseline to Day 4, Day 8 and Day 12 in urinalysis parameters
Description
Single parameters only to be listed if deviation from usual urine dip test, e.g., sediment, leucocytes, nitrite, pH, protein, glucose, ketones, urobilinogen, bilirubin, blood/haemoglobin
Time Frame
Up to Day 12
Title
Number of subjects with abnormal clinical significant ECG evaluation
Description
Evaluation of 12-lead ECG (overall evaluation, assessed by investigator as 'normal', 'abnormal not clinically significant', 'abnormal clinically significant')
Time Frame
Up to Day 12
Title
Number of subjects with abnormal clinically significant findings of physical examination at Day 12.
Description
Evaluation of physical examination (areas skin, heart, lung, abdomen, basic neurological status, general examination of eyes, ears, nose throat), overall evaluation, assessed by investigator as 'normal', 'abnormal not clinically significant', 'abnormal clinically significant'
Time Frame
Up to Day 12
Title
Change from baseline to Day 4, Day 8, Day 12 in systolic and diastolic blood pressure.
Description
measured in mmHg
Time Frame
Up to Day 12
Title
Change from baseline to Day 4, Day 8 and Day 12 in pulse.
Description
measured in beats per minute
Time Frame
Up to Day 12
Title
Change from baseline to Day 4, Day 8 and Day 12 in oral body temperature.
Description
measured in degrees celsius
Time Frame
Up to Day 12
Secondary Outcome Measure Information:
Title
Change from baseline to Day 4, Day 8 and Day 12 in psoriatic infiltrate thickness (assessed by measurement of the thickness of the Echo Poor Band [EPB] of the inflammatory infiltrate using 22-MHz sonography)
Time Frame
12 days
Title
Change from baseline to Day 12 in disease severity
Description
Clinical assessment of change in disease severity (a global assessment performed by an investigator using a 5-point score ('-1 = worsened', '0 = unchanged', '1 = slight improvement', '2 = clear improvement but not completely healed', '3 = completely healed')
Time Frame
12 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects aged 18-64 years (inclusive) with plaque psoriasis in a chronic stable phase. Men or women of non-child bearing potential. Exclusion Criteria: Acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, pustular, exfoliative or inverse psoriasis. According to defined washout periods: topical antipsoriatic drugs (except salicylic acid in petroleum jelly); systemic antipsoriatics and biologics; ultraviolet (UV) therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19055
Country
Germany
Facility Name
Investigational Site
City
Hamburg
ZIP/Postal Code
20095
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamic Effect of Different Concentrations of a New Anti-inflammatory Substance in Subjects With Chronic Plaque Psoriasis

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