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Completed

NCT Number: NCT03669757

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

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

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Key information

Conditions

Psoriasis Vulgaris

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site, Schwerin, Mecklenburg-Vorpommern, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LEO 134310

Drug

Active substance: LEO 134310 is a compound in development at LEO Pharma A/S

LEO 134310 vehicle

Drug

Active substance: none

0.1% betamethasone valerate ointment (class III steroid)

Drug

Active substance: betamethasone valerate

Primary outcomes

  1. Overall number of treatment-emergent adverse events.

    Time frame: Up to Day 19

  2. Number of treatment-emergent application site reactions, by treatment.

    Time frame: Up to Day 19

  3. 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

  4. 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

  5. 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

  6. 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')

  7. 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'

  8. 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

  9. Change from baseline to Day 4, Day 8 and Day 12 in pulse.

    Time frame: Up to Day 12

    measured in beats per minute

  10. 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 outcomes

  1. 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

  2. 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')

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2018
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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