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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669757
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: LEO 134310 Drug: LEO 134310 vehicle Drug: 0.1% betamethasone valerate ointment (class III steroid) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intra-individual comparison of all treatment
Masking: Single (Investigator)
Masking Description: The trial will be performed investigator-blind with random assignment of the 4 Investigational Medicinal Products (IMPs), the placebo and the active comparator.
Primary Purpose: Treatment
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
Actual Study Start Date : September 27, 2018
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: LEO 134310 Dose A
Once daily application
Drug: LEO 134310
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S

Experimental: LEO 134310 Dose B
Once daily application
Drug: LEO 134310
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S

Experimental: LEO 134310 Dose C
Once daily application
Drug: LEO 134310
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S

Experimental: LEO 134310 Dose D
Once daily application
Drug: LEO 134310
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S

Placebo Comparator: LEO 134310 vehicle
Once daily application
Drug: LEO 134310 vehicle
Active substance: none

Active Comparator: 0.1% betamethasone valerate ointment (class III steroid)
Once daily application
Drug: 0.1% betamethasone valerate ointment (class III steroid)
Active substance: betamethasone valerate




Primary Outcome Measures :
  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 Outcome Measures :
  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')



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669757


Locations
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Germany
Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Investigational Site
Hamburg, Germany, 20095
Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Study Director LEO Pharma
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03669757    
Other Study ID Numbers: LP0155-1375
2018-000140-26 ( EudraCT Number )
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents