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Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamics Effect of Calcipotriol/Betamethasone Dipropionate in a New Administration Form in Subjects With Chronic Plaque Psoriasis.

Primary Purpose

Psoriasis Vulgaris

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Microarray patch A

Microarray patch B

Placebo

Daivobet

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Subjects with psoriasis vulgaris in a chronic stable phase and mild to moderate plaque(s) covering a sufficient area to allocate 4 test fields on up to 3 comparable plaques.
Men and women aged 18-70 years (inclusive).
Sufficient target lesion(s) must be present on the trunk or extremities (excluding palms/soles); psoriatic lesions on the knees or elbows are not to be used as target lesions.
Plaques to be treated should have a comparable thickness of the EPB of the inflammatory infiltrate of at least 200 μm.
Plaques to be treated should have no more than a 2-fold difference in infiltrate thickness between the test fields.
Physical examination of skin must be without abnormal, clinical significant findings other than psoriasis vulgaris unless the investigator considers an abnormality to be irrelevant to the trial outcome.

Key Exclusion Criteria:

Other skin disease noted on physical examination that is considered by the investigator to be relevant to the outcome of the trial.
Subjects with acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, pustular, exfoliative or inverse psoriasis.
History of psoriasis that was unresponsive or poorly responsive to topical treatments.
Topical antipsoriatics are not permitted on the same body area as plaques to be treated during the 4 weeks before first treatment and during the trial.
Systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids, dimethylfumarate, apremilast in the 3 months before first treatment and during the trial.
Systemic treatment with biological treatments: rituximab within 12 months, ustekinumab or secukinumab within 6 months before first treatment and during the trial.
Systemic treatment with biological treatments within 3 months before first treatment and during the trial.
Systemic treatment with any other biological treatments within the period of 5 half-lives of the biological before first treatment and during the trial.
UV-therapy or extensive exposure to UV radiation or sunlight within 4 weeks before first treatment and during the trial.
Treatment with concomitant medication that may affect and provoke or aggravate psoriasis, unless on a stable dose for 3 months before trial medication initiation.
Any other topical medication on the plaques to be treated during the trial.
Clinically significant abnormal vital signs (blood pressure, and pulse) at screening (V1).
History/symptoms of a clinically significant illness before first treatment (past 5 years) and during the trial that in the investigator's opinion may place the subject at risk.
History/symptoms of a clinically significant illness before first treatment (past 5 years) and during the trial that in the investigator's opinion may influence the trial outcome.
Other clinically significant abnormal laboratory results.

Sites / Locations

LEO Pharma investigational site
LEO Pharma investigational site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Microarray patch A

Microarray patch B

Vehicle

Daivobet

Arm Description

21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use

21 day treatment, 3 times weekly, 9 applications in total, transdermal patch for cutaneous use

21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use, no active substance

21 day treatment, paused on day 7, day 14 and day 21, Cutaneous use

Outcomes

Primary Outcome Measures

Overall number of treatment-emergent adverse events.

Number of treatment-emergent application site reactions, by treatment

Change from baseline to Day 22 (EoT) in haematology parameters.

RBC, WBC, haemoglobin, haematocrit, platelets, white cell differentials; measured in SI units.

Change from baseline to Day 22 (EoT) in clinical chemistry parameters.

Sodium, potassium, BUN, glucose, AST, ALT, gamma GT, AP, calcium, phosphate, albumin, total cholesterol, LDH, total protein, creatinine, total bilirubin; measured in SI units.

Change from baseline to Day 22 (EoT) in urinalysis parameters, single parameters only to be listed if deviation from usual urine dip test.

E.g., leukocytes, nitrite, pH, protein, glucose, ketones, urobilinogen, bilirubin, blood/haemoglobin, measured in SI units.

Number of subjects with abnormal clinically significant findings of physical examination at Day 22 (EoT).

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 22 (EoT) in systolic and diastolic blood pressure.

Measured in mmHg.

Change from baseline to Day 22 (EoT) in pulse.

Measured in beats per minute.

Frequency counts of overall tolerability assessment of skin reactions at Day 8, Day 15, Day 22, Day 36 and Day 50.

(Assessment performed by an investigator using a 4-point score ['0 = very good', '1 = good', '2 = moderate', '3 = poor']).

Secondary Outcome Measures

Change from baseline (pre-dose at Day 1) to Day 22 (EoT) in psoriatic infiltrate thickness.

(Assessed by measurement of the thickness of the Echo Poor Band [EPB] of the inflammatory infiltrate using 22-MHz sonography; measured in µm).

Full Information

NCT ID

NCT03898583

First Posted

March 29, 2019

Last Updated

September 10, 2020

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT03898583

Brief Title

Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamics Effect of Calcipotriol/Betamethasone Dipropionate in a New Administration Form in Subjects With Chronic Plaque Psoriasis.

Official Title

A Phase 1b, Randomised, Controlled, Assessor-blinded Proof of Principle Trial to Assess Safety, Tolerability and Pharmacodynamics Effects of Microarray Patches Containing Calcipotriol/Betamethasone Dipropionate in Descaled Skin of Adults With Chronic Plaque Psoriasis Over a 21-day Treatment Period

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

April 15, 2019 (Actual)

Primary Completion Date

October 29, 2019 (Actual)

Study Completion Date

October 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To assess safety, tolerability and pharmacodynamics effect of treatment with microarray patches containing calcipotriol and betamethasone dipropionate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Model Description

Intra-individual comparison of all treatments

Masking

Investigator

Masking Description

The trial will be assessor-blinded with random assignment of the 2 microarray patches containing calcipotriol and betamethasone dipropionate, the vehicle (microarray patches without active substance) and the active comparator.

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Microarray patch A

Arm Type

Experimental

Arm Description

21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use

Arm Title

Microarray patch B

Arm Type

Experimental

Arm Description

21 day treatment, 3 times weekly, 9 applications in total, transdermal patch for cutaneous use

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

21 day treatment, once weekly, 3 applications in total, transdermal patch for cutaneous use, no active substance

Arm Title

Daivobet

Arm Type

Active Comparator

Arm Description

21 day treatment, paused on day 7, day 14 and day 21, Cutaneous use

Intervention Type

Drug

Intervention Name(s)

Microarray patch A

Other Intervention Name(s)

Calcipotriol, Betamethasone dipropionate

Intervention Description

Microarray patch

Intervention Type

Drug

Intervention Name(s)

Microarray patch B

Other Intervention Name(s)

Calcipotriol, Betamethasone dipropionate

Intervention Description

Microarray patch

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Microarray patch vehicle

Intervention Type

Drug

Intervention Name(s)

Daivobet

Other Intervention Name(s)

Calcipotriol, Betamethasone dipropionate

Intervention Description

Daivobet Gel

Primary Outcome Measure Information:

Title

Overall number of treatment-emergent adverse events.

Time Frame

First IMP application up to trial end (Day 50)

Title

Number of treatment-emergent application site reactions, by treatment

Time Frame

First IMP application up to trial end (Day 50)

Title

Change from baseline to Day 22 (EoT) in haematology parameters.

Description

RBC, WBC, haemoglobin, haematocrit, platelets, white cell differentials; measured in SI units.

Time Frame

From baseline up to EoT (Day 22)

Title

Change from baseline to Day 22 (EoT) in clinical chemistry parameters.

Description

Sodium, potassium, BUN, glucose, AST, ALT, gamma GT, AP, calcium, phosphate, albumin, total cholesterol, LDH, total protein, creatinine, total bilirubin; measured in SI units.

Time Frame

From baseline to EoT (Day 22)

Title

Change from baseline to Day 22 (EoT) in urinalysis parameters, single parameters only to be listed if deviation from usual urine dip test.

Description

E.g., leukocytes, nitrite, pH, protein, glucose, ketones, urobilinogen, bilirubin, blood/haemoglobin, measured in SI units.

Time Frame

From baseline to EoT (Day 22)

Title

Number of subjects with abnormal clinically significant findings of physical examination at Day 22 (EoT).

Description

Time Frame

EoT (Day 22)

Title

Change from baseline to Day 22 (EoT) in systolic and diastolic blood pressure.

Description

Measured in mmHg.

Time Frame

From baseline to EoT (Day 22)

Title

Change from baseline to Day 22 (EoT) in pulse.

Description

Measured in beats per minute.

Time Frame

From baseline to EoT (Day 22)

Title

Frequency counts of overall tolerability assessment of skin reactions at Day 8, Day 15, Day 22, Day 36 and Day 50.

Description

(Assessment performed by an investigator using a 4-point score ['0 = very good', '1 = good', '2 = moderate', '3 = poor']).

Time Frame

From baseline up to trial end (Day 50)

Secondary Outcome Measure Information:

Title

Change from baseline (pre-dose at Day 1) to Day 22 (EoT) in psoriatic infiltrate thickness.

Description

(Assessed by measurement of the thickness of the Echo Poor Band [EPB] of the inflammatory infiltrate using 22-MHz sonography; measured in µm).

Time Frame

EoT (Day 22)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Subjects with psoriasis vulgaris in a chronic stable phase and mild to moderate plaque(s) covering a sufficient area to allocate 4 test fields on up to 3 comparable plaques. Men and women aged 18-70 years (inclusive). Sufficient target lesion(s) must be present on the trunk or extremities (excluding palms/soles); psoriatic lesions on the knees or elbows are not to be used as target lesions. Plaques to be treated should have a comparable thickness of the EPB of the inflammatory infiltrate of at least 200 μm. Plaques to be treated should have no more than a 2-fold difference in infiltrate thickness between the test fields. Physical examination of skin must be without abnormal, clinical significant findings other than psoriasis vulgaris unless the investigator considers an abnormality to be irrelevant to the trial outcome. Key Exclusion Criteria: Other skin disease noted on physical examination that is considered by the investigator to be relevant to the outcome of the trial. Subjects with acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, pustular, exfoliative or inverse psoriasis. History of psoriasis that was unresponsive or poorly responsive to topical treatments. Topical antipsoriatics are not permitted on the same body area as plaques to be treated during the 4 weeks before first treatment and during the trial. Systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids, dimethylfumarate, apremilast in the 3 months before first treatment and during the trial. Systemic treatment with biological treatments: rituximab within 12 months, ustekinumab or secukinumab within 6 months before first treatment and during the trial. Systemic treatment with biological treatments within 3 months before first treatment and during the trial. Systemic treatment with any other biological treatments within the period of 5 half-lives of the biological before first treatment and during the trial. UV-therapy or extensive exposure to UV radiation or sunlight within 4 weeks before first treatment and during the trial. Treatment with concomitant medication that may affect and provoke or aggravate psoriasis, unless on a stable dose for 3 months before trial medication initiation. Any other topical medication on the plaques to be treated during the trial. Clinically significant abnormal vital signs (blood pressure, and pulse) at screening (V1). History/symptoms of a clinically significant illness before first treatment (past 5 years) and during the trial that in the investigator's opinion may place the subject at risk. History/symptoms of a clinically significant illness before first treatment (past 5 years) and during the trial that in the investigator's opinion may influence the trial outcome. Other clinically significant abnormal laboratory results.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Expert

Organizational Affiliation

LEO Pharma

Official's Role

Study Director

Facility Information:

Facility Name

LEO Pharma investigational site

City

Berlin

ZIP/Postal Code

10783

Country

Germany

Facility Name

LEO Pharma investigational site

City

Hamburg

ZIP/Postal Code

20098

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamics Effect of Calcipotriol/Betamethasone Dipropionate in a New Administration Form in Subjects With Chronic Plaque Psoriasis.

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