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Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris

Primary Purpose

Psoriasis Vulgaris

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
LEO 90100 foam
Dovobet® ointment
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  1. Signed and dated informed consent obtained
  2. Japanese subjects
  3. Aged 20 years or above
  4. Clinical diagnosis of psoriasis vulgaris amenable to topical treatment of less than or equal to 30% BSA (excluding psoriasis on the face/genitals/skin folds).
  5. A target psoriasis lesion of at least mild severity on the body of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of the clinical signs). The lesion must not be on the scalp, face, genitals or skin folds.
  6. Women of childbearing potential must have a negative pregnancy test at Day 1 and agree to use an adequate methods of birth control during the trial.
  7. Able to communicate with the (sub)investigator and understand and comply with the requirements of the trial.

Key Exclusion Criteria:

  1. Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the specified time periods prior to randomisation (depending on treatment)
  2. Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris within 4 weeks prior to randomisation
  3. PUVA therapy, UVB therapy or UVA therapy on the full body or on the target lesion within 4 weeks prior to randomisation
  4. Topical treatment of psoriasis on the areas to be treated with trial medication within 2 weeks prior to randomisation
  5. Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D3 analogues, potent corticosteroids or immunosuppressants within 2 weeks prior to randomisation
  6. Topical treatment of conditions other than psoriasis with vitamin D3 analogues, potent corticosteroids or immunosuppressants within 2 weeks prior to randomisation
  7. Initiation or changes of medication that may affect psoriasis vulgaris during the trial
  8. Patients with certain disorders or symptoms present on the areas to be treated with trial medication: viral lesions of the skin, infections, skin manifestations, or fragility of skin veins
  9. Other inflammatory skin diseases that may confound the evaluation of psoriasis vulgaris
  10. Erythrodermic, exfoliative or pustular psoriasis on the areas to be treated with trial medication
  11. Planned excessive exposure of areas to be treated with trial medication to either natural or artificial sunlight during the trial.
  12. Disorders of calcium metabolism
  13. Severe renal insufficiency, severe hepatic disorders or severe heart disease
  14. Hypersensitivity to any components of the investigational medicinal products.
  15. Cushing's disease or Addison's disease
  16. Subjects who have received treatment with any non-marketed drug substance within the 4 weeks prior to randomisation, or longer if for certain biological treatments
  17. History of cancer within the last 5 years (except completely cured skin cancer)
  18. Current participation in any other interventional clinical trial
  19. Previously randomised in this trial
  20. Women who are pregnant, wishing to become pregnant or are breast-feeding
  21. Chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance
  22. Employees of the trial site or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals

Sites / Locations

  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LEO 90100 foam

Dovobet® ointment

Arm Description

calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g

calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g

Outcomes

Primary Outcome Measures

Overall Improvement Rate for the Target Lesion
Overall improvement defined as 'Substantial Resolution' of Clinical Signs or at Least 'Moderately Improved' in the General Change in the Lesion. Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the target lesion. The details of the clinical scores are presented in secondary outcome measure description for 'Change in the total sign score'. Change in the Lesion is a 5 point scale below: Markedly improved (best outcome) Moderately improved Slightly improved Unchanged Aggravated (worst outcome)

Secondary Outcome Measures

Overall Improvement Rate for the Target Lesion at Weeks 1 and 2
Substantial resolution of clinical signs or at least 'moderately improved' in the general change in the target lesion. Change in the Lesion is a 5 point scale below: Markedly improved (best outcome) Moderately improved Slightly improved Unchanged Aggravated (worst outcome)
Change in the Total Sign Score for the Target Lesion From Week 0 to Week 4
The change in the total sign score from Week 0 to Week 4; total sign score is defined as the sum of the scores from the 3 clinical signs (redness, thickness, and scaliness) assessing severity in the target lesion. The severity for each of the 3 clinical signs was recorded according to a 9-point scale that ranges from a score of 0 to 4 in increments of 0.5; the severities are scored from low to high with 0 = none and 4 = severe. The sum of the 3 total sign scores could range from 0 (best) to 12 (worse). The greater the negative value for the change means a better outcome. Negative change denotes a decrease in the score and therefore a decrease in disease severity.
Number of Adverse Events
Number of treatment emergent adverse events (TEAEs). 14-day follow-up of TEAEs was only required if the TEAE was present at the last visit, and was of possible or probable relationship to trial medication.

Full Information

First Posted
January 15, 2019
Last Updated
November 20, 2020
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03806790
Brief Title
Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris
Official Title
Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 24, 2019 (Actual)
Primary Completion Date
June 10, 2019 (Actual)
Study Completion Date
June 10, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparison of the efficacy of LEO 90100 foam with Dovobet® ointment in the treatment of psoriasis in Japanese subjects.
Detailed Description
A phase 3, national, multi-centre, 4-week, prospective, randomised, controlled, parallel-group, open trial of LEO 90100 foam versus Dovobet® ointment (both treatments containing calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with psoriasis vulgaris.

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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LEO 90100 foam
Arm Type
Experimental
Arm Description
calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g
Arm Title
Dovobet® ointment
Arm Type
Active Comparator
Arm Description
calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g
Intervention Type
Drug
Intervention Name(s)
LEO 90100 foam
Other Intervention Name(s)
Enstilar® Foam
Intervention Description
Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.
Intervention Type
Drug
Intervention Name(s)
Dovobet® ointment
Intervention Description
Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.
Primary Outcome Measure Information:
Title
Overall Improvement Rate for the Target Lesion
Description
Overall improvement defined as 'Substantial Resolution' of Clinical Signs or at Least 'Moderately Improved' in the General Change in the Lesion. Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the target lesion. The details of the clinical scores are presented in secondary outcome measure description for 'Change in the total sign score'. Change in the Lesion is a 5 point scale below: Markedly improved (best outcome) Moderately improved Slightly improved Unchanged Aggravated (worst outcome)
Time Frame
End of Week 4
Secondary Outcome Measure Information:
Title
Overall Improvement Rate for the Target Lesion at Weeks 1 and 2
Description
Substantial resolution of clinical signs or at least 'moderately improved' in the general change in the target lesion. Change in the Lesion is a 5 point scale below: Markedly improved (best outcome) Moderately improved Slightly improved Unchanged Aggravated (worst outcome)
Time Frame
End of Weeks 1 and 2
Title
Change in the Total Sign Score for the Target Lesion From Week 0 to Week 4
Description
The change in the total sign score from Week 0 to Week 4; total sign score is defined as the sum of the scores from the 3 clinical signs (redness, thickness, and scaliness) assessing severity in the target lesion. The severity for each of the 3 clinical signs was recorded according to a 9-point scale that ranges from a score of 0 to 4 in increments of 0.5; the severities are scored from low to high with 0 = none and 4 = severe. The sum of the 3 total sign scores could range from 0 (best) to 12 (worse). The greater the negative value for the change means a better outcome. Negative change denotes a decrease in the score and therefore a decrease in disease severity.
Time Frame
End of Week 4
Title
Number of Adverse Events
Description
Number of treatment emergent adverse events (TEAEs). 14-day follow-up of TEAEs was only required if the TEAE was present at the last visit, and was of possible or probable relationship to trial medication.
Time Frame
Treatment Emergent Adverse Events were assessed from Day 1 to end of Week 4, if Treatment Emergent Adverse Events were noted, they were followed for an additional 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Signed and dated informed consent obtained Japanese subjects Aged 20 years or above Clinical diagnosis of psoriasis vulgaris amenable to topical treatment of less than or equal to 30% BSA (excluding psoriasis on the face/genitals/skin folds). A target psoriasis lesion of at least mild severity on the body of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of the clinical signs). The lesion must not be on the scalp, face, genitals or skin folds. Women of childbearing potential must have a negative pregnancy test at Day 1 and agree to use an adequate methods of birth control during the trial. Able to communicate with the (sub)investigator and understand and comply with the requirements of the trial. Key Exclusion Criteria: Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the specified time periods prior to randomisation (depending on treatment) Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris within 4 weeks prior to randomisation PUVA therapy, UVB therapy or UVA therapy on the full body or on the target lesion within 4 weeks prior to randomisation Topical treatment of psoriasis on the areas to be treated with trial medication within 2 weeks prior to randomisation Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D3 analogues, potent corticosteroids or immunosuppressants within 2 weeks prior to randomisation Topical treatment of conditions other than psoriasis with vitamin D3 analogues, potent corticosteroids or immunosuppressants within 2 weeks prior to randomisation Initiation or changes of medication that may affect psoriasis vulgaris during the trial Patients with certain disorders or symptoms present on the areas to be treated with trial medication: viral lesions of the skin, infections, skin manifestations, or fragility of skin veins Other inflammatory skin diseases that may confound the evaluation of psoriasis vulgaris Erythrodermic, exfoliative or pustular psoriasis on the areas to be treated with trial medication Planned excessive exposure of areas to be treated with trial medication to either natural or artificial sunlight during the trial. Disorders of calcium metabolism Severe renal insufficiency, severe hepatic disorders or severe heart disease Hypersensitivity to any components of the investigational medicinal products. Cushing's disease or Addison's disease Subjects who have received treatment with any non-marketed drug substance within the 4 weeks prior to randomisation, or longer if for certain biological treatments History of cancer within the last 5 years (except completely cured skin cancer) Current participation in any other interventional clinical trial Previously randomised in this trial Women who are pregnant, wishing to become pregnant or are breast-feeding Chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance Employees of the trial site or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals
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
Fukutsu
State/Province
Fukuoka
ZIP/Postal Code
811-3217
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Obihiro
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
004-0063
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
006-0814
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0807
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Nonoichi
State/Province
Ishikawa
ZIP/Postal Code
921-8801
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
213-0001
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
220-6208
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
981-3133
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
330-0854
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8605
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Kita-ku
State/Province
Tokyo
ZIP/Postal Code
115-0045
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Koto-Ku
State/Province
Tokyo
ZIP/Postal Code
136-0074
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Minato-Ku
State/Province
Tokyo
ZIP/Postal Code
108-0014
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Setagaya
State/Province
Tokyo
ZIP/Postal Code
158-0094
Country
Japan
Facility Name
Leo Pharma Investigational Site
City
Setagaya
State/Province
Tokyo
ZIP/Postal Code
158-0097
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified Individual Participant Data can be made available to researchers in a closed environment for a specified period of time.
IPD Sharing Time Frame
Data are available to request after results of the trial are available on leopharmatrials.com
IPD Sharing Access Criteria
Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
IPD Sharing URL
http://leopharmatrials.com/for-professionals

Learn more about this trial

Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris

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