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

NCT03669757 | Completed Phase 1

• 2 other identifiers: LP0155-13752018-000140-26
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (10)

• 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.

  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

Secondary Outcomes (2)

• 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

Study Arms (6)

LEO 134310 Dose A

EXPERIMENTAL

Once daily application

Drug: LEO 134310

LEO 134310 Dose B

EXPERIMENTAL

Once daily application

Drug: LEO 134310

LEO 134310 Dose C

EXPERIMENTAL

Once daily application

Drug: LEO 134310

LEO 134310 Dose D

EXPERIMENTAL

Once daily application

Drug: LEO 134310

LEO 134310 vehicle

PLACEBO COMPARATOR

Once daily application

Drug: LEO 134310 vehicle

0.1% betamethasone valerate ointment (class III steroid)

ACTIVE COMPARATOR

Once daily application

Drug: 0.1% betamethasone valerate ointment (class III steroid)

Interventions

LEO 134310 DRUG

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

LEO 134310 Dose A

LEO 134310 vehicle DRUG

Active substance: none

LEO 134310 vehicle

0.1% betamethasone valerate ointment (class III steroid) DRUG

Active substance: betamethasone valerate

0.1% betamethasone valerate ointment (class III steroid)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects aged 18-64 years (inclusive) with plaque psoriasis in a chronic stable phase.
• Men or women of non-child bearing potential.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (2)

Investigational Site

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

Investigational Site

Hamburg, 20095, Germany

Location

Study Officials

• Study Director

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The trial will be performed investigator-blind with random assignment of the 4 Investigational Medicinal Products (IMPs), the placebo and the active comparator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intra-individual comparison of all treatment

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: September 13, 2018
• Study Start: September 27, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: October 26, 2024

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)