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A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis

Primary Purpose

Stable Plaque Psoriasis

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
LEO 90100
Daivobet® ointment
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Plaque Psoriasis focused on measuring Stable plaque psoriasis, Vitamin D analogue, Native Chinese subjects

Eligibility Criteria

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

Inclusion Criteria: Chinese native Aged 18 or over A clinical diagnosis of stable plaque psoriasis for at least 6 months Stable plaque psoriasis on the trunk and/or limbs (excluding psoriasis on the face, scalp, genitals, and skin folds) involving 2-30% of the body surface at Day 1 (Visit 2) of the trial. Having a Physician Global Assessment of at least 'mild' at Day 1 (Visit 2) An mPASI score of at least 2 on the trunk and/or limbs at Day 1 (Visit 2) Women of childbearing potential must use an adequate form of birth control throughout the trial and for at least 8 weeks after last administration of IMP Male subjects with a female partner of childbearing potential must use adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) Having a signed and dated informed consent. Exclusion Criteria: Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the specified time periods prior to treatment assignment (depending on treatment) Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris within 4 weeks prior to treatment assignment Psoralen combined with ultraviolet A therapy (PUVA) within 4 weeks prior to treatment assignment Systemic treatment with Apremilast within 4 weeks prior to treatment assignment Ultraviolet B (UVB) therapy within 2 weeks prior to treatment assignment Topical treatment of psoriasis with strong corticosteroids within 2 weeks prior to treatment assignment Topical treatment of psoriasis with traditional Chinese medicine within 2 weeks prior to treatment assignment Treatment with any non-marketed drug substance (any agent which has not yet been made available for clinical use) within 4 weeks/5 half-lives prior to treatment assignment Any other topical treatment that could affect plaque psoriasis within 2 weeks prior to treatment assignment Current diagnosis of guttate, erythrodermic, exfoliative, pustular or unstable psoriasis Patients with any of the following conditions present on any skin area: viral lesions, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds Disorders of calcium metabolism Renal insufficiency, hepatic disorders or severe heart disease Cushing's disease or Addison's disease Known or suspected hypersensitivity to any component(s) of the investigational medicinal product (IMP) Current participation in any other interventional clinical trial Previously screened in this trial Participation in another clinical trial within 4 weeks prior to treatment assignment 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

Sites / Locations

  • First Hospital of Bengbu Medical College
  • First Hospital of Bengbu Medical CollegeRecruiting
  • Peking Univ People's HospitalRecruiting
  • Beijing Friendship HospitalRecruiting
  • Chongqing Hospital, Traditional Chinese Medicine
  • Chongqing Hospital, Traditional Chinese MedicineRecruiting
  • First Hospital of Chongqing Medical UniversityRecruiting
  • Guangdong Provincial People's HospitalRecruiting
  • Derma Hospital of Southern Medical University
  • Dermatology Hospital of Southern Medical UniversityRecruiting
  • Shenzhen People's HospitalRecruiting
  • Chengde Medical College HospitalRecruiting
  • Hebei Medical University, First HospitalRecruiting
  • First People's Hospital NanyangRecruiting
  • Shiyan Renmin Hospital
  • Shiyan Renmin HospitalRecruiting
  • Union Hospital Tongji Medical CollegeRecruiting
  • Central South University, Second Xiangya Hospital
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • Baotou Central HospitalRecruiting
  • IMMU Baogang HospitalRecruiting
  • Subei People's Hospital, Jiangsu ProvinceRecruiting
  • Jiangsu University Hospital
  • Jiangsu University HospitalRecruiting
  • First Hosp of Jilin University
  • First Hospital of Jilin UniversityRecruiting
  • First Hospital Xi'an Jiaotong UniversityRecruiting
  • Shengli Oilfield Central HospitalRecruiting
  • Jinan Central HospitalRecruiting
  • Dermatology Hospital of Shandong First Medical University
  • Shanghai Dermatology HospitalRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • Suining Central HospitalRecruiting
  • First Hospital of Zhejiang University
  • Hangzhou Third People's Hospital
  • Second Hospital of Zhejiang University
  • Second Hospital of Zhejiang UniversityRecruiting
  • Zhejiang Provincial People's HospitalRecruiting
  • Sir Run Run Shaw Hospital
  • The First Hospital of JiaxingRecruiting
  • Ningbo No.2 HospitalRecruiting
  • Ningbo First HospitalRecruiting
  • First Affiliated Hospital of Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LEO 90100

Daivobet® ointment

Arm Description

The subjects will receive LEO 90100 foam once daily for 4 weeks.

The subjects will receive Daivobet® ointment once daily for 4 weeks.

Outcomes

Primary Outcome Measures

Physician's Global Assessment of disease severity (PGA) score of 0 (clear) or 1 (almost clear) at Day 29, with at least a 2-point reduction from baseline
The PGA is an instrument used in clinical trials to rate the severity of psoriasis. It is a 5-point scale measurement ranging from 0 to 4, where 0- clear, 1- almost clear, 2- mild, 3- moderate and 4- severe; based on degree of plaque thickening, scaling and erythema.

Secondary Outcome Measures

A decrease in Modified Psoriasis Area and Severity Index of at least 75% (mPASI-75) from baseline to Day 29
The extent of psoriatic involvement will be recorded for each of the areas (trunk [including the neck] and the limbs [such as arms and legs]; excluding any involvement on face, scalp, genitals and skin folds) using the following scale: 0=no involvement 1=< 10% 2=10%-29% 3=30%-49% 4=50%-69% 5=70%-89% 6=90%-100%. The severity of the psoriatic lesions in each of the areas will be recorded for each of the clinical signs of redness, thickness and scaliness. Each clinical sign is scored on a scale of 0-4, reflecting the average severity of all psoriatic lesions on the given body region. Higher score indicates more severity. The overall mPASI can range from 0 to 64.8.
A decrease in mPASI of at least 90% (mPASI-90) from baseline to Day 29
The extent of psoriatic involvement will be recorded for each of the areas (trunk [including the neck] and the limbs [such as arms and legs]; excluding any involvement on face, scalp, genitals and skin folds) using the following scale: 0=no involvement 1=< 10% 2=10%-29% 3=30%-49% 4=50%-69% 5=70%-89% 6=90%-100%. The severity of the psoriatic lesions in each of the areas will be recorded for each of the clinical signs of redness, thickness and scaliness. Each clinical sign is scored on a scale of 0-4, reflecting the average severity of all psoriatic lesions on the given body region. Higher score indicates more severity. The overall mPASI can range from 0 to 64.8.
Number of subjects with treatment-emergent adverse events (TEAEs)

Full Information

First Posted
June 16, 2023
Last Updated
September 29, 2023
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT05919082
Brief Title
A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis
Official Title
A Phase 3, Randomised, Investigator-blind, Active-controlled, Parallel Group, Multicentre Trial Comparing the Efficacy and Safety of 4-weeks Treatment With LEO 90100 and Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2023 (Actual)
Primary Completion Date
June 19, 2024 (Anticipated)
Study Completion Date
July 2, 2024 (Anticipated)

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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is conducted to assess the efficacy and safety of LEO 90100 when used on the body for the treatment of stable plaque psoriasis in native adult Chinese subjects, compared to Daivobet® ointment.
Detailed Description
This study is phase 3, randomised, prospective, investigator-blinded, active-controlled, parallel group, multicentre trial to evaluate the efficacy and safety of 4 weeks treatment with LEO 90100 compared with Daivobet® ointment. Eligible participants will be randomised in a 1:1 ratio to either LEO 90100 or Daivobet® ointment treatment. The trial will last for 6 weeks to 10 weeks for each participant, which includes wash out period and treatment period of up to 4 weeks and a safety follow up period of 2 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Plaque Psoriasis
Keywords
Stable plaque psoriasis, Vitamin D analogue, Native Chinese subjects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LEO 90100
Arm Type
Experimental
Arm Description
The subjects will receive LEO 90100 foam once daily for 4 weeks.
Arm Title
Daivobet® ointment
Arm Type
Active Comparator
Arm Description
The subjects will receive Daivobet® ointment once daily for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
LEO 90100
Intervention Description
Subjects will apply LEO 90100 topically; up to 15 g per day (or 105 g per week).
Intervention Type
Drug
Intervention Name(s)
Daivobet® ointment
Intervention Description
Subjects will apply Daivobet® ointment topically; up to 15 g per day (or 105 g per week).
Primary Outcome Measure Information:
Title
Physician's Global Assessment of disease severity (PGA) score of 0 (clear) or 1 (almost clear) at Day 29, with at least a 2-point reduction from baseline
Description
The PGA is an instrument used in clinical trials to rate the severity of psoriasis. It is a 5-point scale measurement ranging from 0 to 4, where 0- clear, 1- almost clear, 2- mild, 3- moderate and 4- severe; based on degree of plaque thickening, scaling and erythema.
Time Frame
From baseline to Day 29
Secondary Outcome Measure Information:
Title
A decrease in Modified Psoriasis Area and Severity Index of at least 75% (mPASI-75) from baseline to Day 29
Description
The extent of psoriatic involvement will be recorded for each of the areas (trunk [including the neck] and the limbs [such as arms and legs]; excluding any involvement on face, scalp, genitals and skin folds) using the following scale: 0=no involvement 1=< 10% 2=10%-29% 3=30%-49% 4=50%-69% 5=70%-89% 6=90%-100%. The severity of the psoriatic lesions in each of the areas will be recorded for each of the clinical signs of redness, thickness and scaliness. Each clinical sign is scored on a scale of 0-4, reflecting the average severity of all psoriatic lesions on the given body region. Higher score indicates more severity. The overall mPASI can range from 0 to 64.8.
Time Frame
From baseline to Day 29
Title
A decrease in mPASI of at least 90% (mPASI-90) from baseline to Day 29
Description
The extent of psoriatic involvement will be recorded for each of the areas (trunk [including the neck] and the limbs [such as arms and legs]; excluding any involvement on face, scalp, genitals and skin folds) using the following scale: 0=no involvement 1=< 10% 2=10%-29% 3=30%-49% 4=50%-69% 5=70%-89% 6=90%-100%. The severity of the psoriatic lesions in each of the areas will be recorded for each of the clinical signs of redness, thickness and scaliness. Each clinical sign is scored on a scale of 0-4, reflecting the average severity of all psoriatic lesions on the given body region. Higher score indicates more severity. The overall mPASI can range from 0 to 64.8.
Time Frame
From baseline to Day 29
Title
Number of subjects with treatment-emergent adverse events (TEAEs)
Time Frame
From baseline to Day 43

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chinese native Aged 18 or over A clinical diagnosis of stable plaque psoriasis for at least 6 months Stable plaque psoriasis on the trunk and/or limbs (excluding psoriasis on the face, scalp, genitals, and skin folds) involving 2-30% of the body surface at Day 1 (Visit 2) of the trial. Having a Physician Global Assessment of at least 'mild' at Day 1 (Visit 2) An mPASI score of at least 2 on the trunk and/or limbs at Day 1 (Visit 2) Women of childbearing potential must use an adequate form of birth control throughout the trial and for at least 8 weeks after last administration of IMP Male subjects with a female partner of childbearing potential must use adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) Having a signed and dated informed consent. Exclusion Criteria: Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the specified time periods prior to treatment assignment (depending on treatment) Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris within 4 weeks prior to treatment assignment Psoralen combined with ultraviolet A therapy (PUVA) within 4 weeks prior to treatment assignment Systemic treatment with Apremilast within 4 weeks prior to treatment assignment Ultraviolet B (UVB) therapy within 2 weeks prior to treatment assignment Topical treatment of psoriasis with strong corticosteroids within 2 weeks prior to treatment assignment Topical treatment of psoriasis with traditional Chinese medicine within 2 weeks prior to treatment assignment Treatment with any non-marketed drug substance (any agent which has not yet been made available for clinical use) within 4 weeks/5 half-lives prior to treatment assignment Any other topical treatment that could affect plaque psoriasis within 2 weeks prior to treatment assignment Current diagnosis of guttate, erythrodermic, exfoliative, pustular or unstable psoriasis Patients with any of the following conditions present on any skin area: viral lesions, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds Disorders of calcium metabolism Renal insufficiency, hepatic disorders or severe heart disease Cushing's disease or Addison's disease Known or suspected hypersensitivity to any component(s) of the investigational medicinal product (IMP) Current participation in any other interventional clinical trial Previously screened in this trial Participation in another clinical trial within 4 weeks prior to treatment assignment 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Disclosure
Phone
(+1) 877-557-1168
Email
clinicaltrialscontactus@leo-pharma.com
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
First Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233060
Country
China
Individual Site Status
Not yet recruiting
Facility Name
First Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233060
Country
China
Individual Site Status
Recruiting
Facility Name
Peking Univ People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Name
Chongqing Hospital, Traditional Chinese Medicine
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400021
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Chongqing Hospital, Traditional Chinese Medicine
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400021
Country
China
Individual Site Status
Recruiting
Facility Name
First Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Derma Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
516006
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Dermatology Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
516006
Country
China
Individual Site Status
Recruiting
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Name
Chengde Medical College Hospital
City
Chengde
State/Province
Hebei
ZIP/Postal Code
067000
Country
China
Individual Site Status
Recruiting
Facility Name
Hebei Medical University, First Hospital
City
Shijiangzhuang
State/Province
Hebei
ZIP/Postal Code
050030
Country
China
Individual Site Status
Recruiting
Facility Name
First People's Hospital Nanyang
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473004
Country
China
Individual Site Status
Recruiting
Facility Name
Shiyan Renmin Hospital
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Shiyan Renmin Hospital
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442000
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital Tongji Medical College
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Central South University, Second Xiangya Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Name
Baotou Central Hospital
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Individual Site Status
Recruiting
Facility Name
IMMU Baogang Hospital
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014016
Country
China
Individual Site Status
Recruiting
Facility Name
Subei People's Hospital, Jiangsu Province
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225003
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu University Hospital
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Jiangsu University Hospital
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Individual Site Status
Recruiting
Facility Name
First Hosp of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
First Hospital Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Shengli Oilfield Central Hospital
City
Dongying
State/Province
Shandong
ZIP/Postal Code
257099
Country
China
Individual Site Status
Recruiting
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Name
Dermatology Hospital of Shandong First Medical University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250022
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Shanghai Dermatology Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200443
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610044
Country
China
Individual Site Status
Recruiting
Facility Name
Suining Central Hospital
City
Suining
State/Province
Sichuan
ZIP/Postal Code
629000
Country
China
Individual Site Status
Recruiting
Facility Name
First Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Hangzhou Third People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Second Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Second Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Hospital of Jiaxing
City
Jiaxing
State/Province
Zhejiang
ZIP/Postal Code
314001
Country
China
Individual Site Status
Recruiting
Facility Name
Ningbo No.2 Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Individual Site Status
Recruiting
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315016
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Access Criteria
De-identified Individual Participant Data can be made available to researchers and 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

A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis

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