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

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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: LEO 134310; Drug: LEO 134310 vehicle; Drug: 0.1% betamethasone valerate ointment (class III steroid)

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20095
    • Investigational Site
  • Mecklenburg-Vorpommern
    • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
      • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LEO 134310 Dose A; Once daily application	Drug: LEO 134310; Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
Experimental: LEO 134310 Dose B; Once daily application	Drug: LEO 134310; Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
Experimental: LEO 134310 Dose C; Once daily application	Drug: LEO 134310; Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
Experimental: LEO 134310 Dose D; Once daily application	Drug: LEO 134310; Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
Placebo Comparator: LEO 134310 vehicle; Once daily application	Drug: LEO 134310 vehicle; Active substance: none
Active Comparator: 0.1% betamethasone valerate ointment (class III steroid); Once daily application	Drug: 0.1% betamethasone valerate ointment (class III steroid); Active substance: betamethasone valerate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall number of treatment-emergent adverse events.		Up to Day 19
Number of treatment-emergent application site reactions, by treatment.		Up to Day 19
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	Up to Day 12
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	Up to Day 12
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	Up to Day 12
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')	Up to Day 12
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'	Up to Day 12
Change from baseline to Day 4, Day 8, Day 12 in systolic and diastolic blood pressure.	measured in mmHg	Up to Day 12
Change from baseline to Day 4, Day 8 and Day 12 in pulse.	measured in beats per minute	Up to Day 12
Change from baseline to Day 4, Day 8 and Day 12 in oral body temperature.	measured in degrees celsius	Up to Day 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)		12 days
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')	12 days

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Study Director, LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Respiratory System Agents; Anti-Asthmatic Agents; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate
• Other Study ID Numbers: LP0155-1375; 2018-000140-26 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No