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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000140-26 | EudraCT Number |
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To assess safety and tolerability after treatment with LEO 134310 cutaneous solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 134310 Dose A | Experimental | Once daily application |
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| LEO 134310 Dose B | Experimental | Once daily application |
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| LEO 134310 Dose C | Experimental | Once daily application |
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| LEO 134310 Dose D | Experimental | Once daily application |
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| LEO 134310 vehicle | Placebo Comparator | Once daily application |
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| 0.1% betamethasone valerate ointment (class III steroid) | Active Comparator | Once daily application |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 134310 | Drug | Active substance: LEO 134310 is a compound in development at LEO Pharma A/S |
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| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Schwerin | Mecklenburg-Vorpommern | 19055 | Germany | ||
| Investigational Site |
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Intra-individual comparison of all treatment
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The trial will be performed investigator-blind with random assignment of the 4 Investigational Medicinal Products (IMPs), the placebo and the active comparator.
| LEO 134310 | Drug | Active substance: LEO 134310 is a compound in development at LEO Pharma A/S |
|
| LEO 134310 | Drug | Active substance: LEO 134310 is a compound in development at LEO Pharma A/S |
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| LEO 134310 | Drug | Active substance: LEO 134310 is a compound in development at LEO Pharma A/S |
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| LEO 134310 vehicle | Drug | Active substance: none |
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| 0.1% betamethasone valerate ointment (class III steroid) | Drug | Active substance: betamethasone valerate |
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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 |
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 |
| Hamburg |
| 20095 |
| Germany |