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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: February 1, 2019

Interventions

  • Drug: LEO 134310
    • Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
  • Drug: LEO 134310
    • Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
  • Drug: LEO 134310
    • Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
  • Drug: LEO 134310
    • Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
  • Drug: LEO 134310 vehicle
    • Active substance: none
  • Drug: 0.1% betamethasone valerate ointment (class III steroid)
    • Active substance: betamethasone valerate

Arms, Groups and Cohorts

  • Experimental: LEO 134310 Dose A
    • Once daily application
  • Experimental: LEO 134310 Dose B
    • Once daily application
  • Experimental: LEO 134310 Dose C
    • Once daily application
  • Experimental: LEO 134310 Dose D
    • Once daily application
  • Placebo Comparator: LEO 134310 vehicle
    • Once daily application
  • Active Comparator: 0.1% betamethasone valerate ointment (class III steroid)
    • Once daily application

Clinical Trial Outcome Measures

Primary Measures

  • Overall number of treatment-emergent adverse events.
    • Time Frame: Up to Day 19
  • Number of treatment-emergent application site reactions, by treatment.
    • Time Frame: Up to Day 19
  • Change from baseline to Day 4, Day 8 and Day 12 in haematology parameters
    • Time Frame: Up to Day 12
    • 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
    • Time Frame: Up to Day 12
    • 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
    • Time Frame: Up to Day 12
    • 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
    • Time Frame: Up to Day 12
    • 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.
    • Time Frame: Up to 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.
    • Time Frame: Up to Day 12
    • measured in mmHg
  • Change from baseline to Day 4, Day 8 and Day 12 in pulse.
    • Time Frame: Up to Day 12
    • measured in beats per minute
  • Change from baseline to Day 4, Day 8 and Day 12 in oral body temperature.
    • Time Frame: Up to Day 12
    • measured in degrees celsius

Secondary 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)
    • Time Frame: 12 days
  • Change from baseline to Day 12 in disease severity
    • Time Frame: 12 days
    • 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’)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • LEO Pharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, LEO Pharma

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