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

Phase 1

Completed

• Conditions: Psoriasis Vulgaris
• Interventions: Drug: 0.1% betamethasone valerate ointment (class III steroid); Drug: LEO 134310; Drug: LEO 134310 vehicle

• Registration Number: NCT03669757
• Lead Sponsor: LEO Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-13
• Study Start: 2018-09-27
• Status Verified: 2019-02
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.1% betamethasone valerate ointment (class III steroid)	0.1% betamethasone valerate ointment (class III steroid)	Once daily application
LEO 134310 Dose C	LEO 134310	Once daily application
LEO 134310 vehicle	LEO 134310 vehicle	Once daily application
LEO 134310 Dose D	LEO 134310	Once daily application
LEO 134310 Dose B	LEO 134310	Once daily application
LEO 134310 Dose A	LEO 134310	Once daily application

Primary Outcome Measures

Name	Time	Method
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 oral body temperature.	Up to Day 12	measured in degrees celsius
Change from baseline to Day 4, Day 8 and Day 12 in pulse.	Up to Day 12	measured in beats per minute
Change from baseline to Day 4, Day 8 and Day 12 in haematology parameters	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	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
Number of subjects with abnormal clinically significant findings of physical examination at Day 12.	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 and Day 12 in urinalysis parameters	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	Up to Day 12	Evaluation of 12-lead ECG (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.	Up to Day 12	measured in mmHg

Secondary Outcome Measures

Name	Time	Method
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	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')

Trial Locations

Locations (1)

Investigational Site; 🇩🇪 Hamburg, Germany