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

Psoriasis Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669757
• Other study ID #: LP0155-1375
• Secondary ID: 2018-000140-26
• Status: Completed
• Phase: Phase 1
• Start date: September 27, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2019
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

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

Locations

Country	Name	City	State
Germany	Investigational Site	Hamburg
Germany	Investigational Site	Schwerin	Mecklenburg-Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome

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