- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05919082
A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Clinical Disclosure
- Phone Number: (+1) 877-557-1168
- Email: clinicaltrialscontactus@leo-pharma.com
Study Locations
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Anhui
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Bengbu, Anhui, China, 233060
- LEO Pharma Investigational Site
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Hefei, Anhui, China, 230022
- LEO Pharma Investigational Site
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Beijing
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Beijing, Beijing, China, 100044
- LEO Pharma Investigational Site
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Beijing, Beijing, China, 100050
- LEO Pharma Investigational Site
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Chongqing
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Chongqing, Chongqing, China, 400021
- LEO Pharma Investigational Site
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Chongqing, Chongqing, China, 400042
- LEO Pharma Investigational Site
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Guangdong
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Guangzhou, Guangdong, China, 510080
- LEO Pharma Investigational Site
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Guangzhou, Guangdong, China, 516006
- LEO Pharma Investigational Site
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Shenzhen, Guangdong, China, 518020
- LEO Pharma Investigational Site
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Hebei
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Cangzhou, Hebei, China, 061000
- LEO Pharma Investigational Site
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Chengde, Hebei, China, 067000
- LEO Pharma Investigational Site
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Shijiangzhuang, Hebei, China, 050030
- LEO Pharma Investigational Site
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Henan
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Nanyang, Henan, China, 473004
- LEO Pharma Investigational Site
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Hubei
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Shiyan, Hubei, China, 442000
- LEO Pharma Investigational Site
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Wuhan, Hubei, China, 430022
- LEO Pharma Investigational Site
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Hunan
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Changsha, Hunan, China, 410011
- LEO Pharma Investigational Site
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Inner Mongolia
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Baotou, Inner Mongolia, China, 014010
- LEO Pharma Investigational Site
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Baotou, Inner Mongolia, China, 014016
- LEO Pharma Investigational Site
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Hohhot, Inner Mongolia, China, 010000
- LEO Pharma Investigational Site
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Jiangsu
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Wuxi, Jiangsu, China, 214002
- LEO Pharma Investigational Site
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Yangzhou, Jiangsu, China, 225003
- LEO Pharma Investigational Site
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Zhenjiang, Jiangsu, China, 212001
- LEO Pharma Investigational Site
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Jilin
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Changchun, Jilin, China, 130021
- LEO Pharma Investigational Site
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Shaanxi
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Xi'an, Shaanxi, China, 510080
- LEO Pharma Investigational Site
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Shandong
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Dongying, Shandong, China, 257099
- LEO Pharma Investigational Site
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Jinan, Shandong, China, 250013
- LEO Pharma Investigational Site
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Jinan, Shandong, China, 250022
- LEO Pharma Investigational Site
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Shanghai
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Shanghai, Shanghai, China, 200443
- LEO Pharma Investigational Site
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Sichuan
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Chengdu, Sichuan, China, 610044
- LEO Pharma Investigational Site
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Suining, Sichuan, China, 629000
- LEO Pharma Investigational Site
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- LEO Pharma Investigational Site
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Hangzhou, Zhejiang, China, 310009
- LEO Pharma Investigational Site
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Hangzhou, Zhejiang, China, 310014
- LEO Pharma Investigational Site
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Hangzhou, Zhejiang, China, 310016
- LEO Pharma Investigational Site
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Jiaxing, Zhejiang, China, 314001
- LEO Pharma Investigational Site
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Ningbo, Zhejiang, China, 315010
- LEO Pharma Investigational Site
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Ningbo, Zhejiang, China, 315016
- LEO Pharma Investigational Site
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Wenzhou, Zhejiang, China, 325000
- LEO Pharma Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: LEO 90100
The subjects will receive LEO 90100 foam once daily for 4 weeks.
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Subjects will apply LEO 90100 topically; up to 15 g per day (or 105 g per week).
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Active Comparator: Daivobet® ointment
The subjects will receive Daivobet® ointment once daily for 4 weeks.
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Subjects will apply Daivobet® ointment topically; up to 15 g per day (or 105 g per week).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: From baseline to Day 29
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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.
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From baseline to Day 29
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A decrease in Modified Psoriasis Area and Severity Index of at least 75% (mPASI-75) from baseline to Day 29
Time Frame: From baseline to Day 29
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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.
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From baseline to Day 29
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A decrease in mPASI of at least 90% (mPASI-90) from baseline to Day 29
Time Frame: From baseline to Day 29
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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.
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From baseline to Day 29
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Number of subjects with treatment-emergent adverse events (TEAEs)
Time Frame: From baseline to Day 43
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From baseline to Day 43
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Medical Expert, LEO Pharma
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LP0053-2277
- U1111-1285-7764 (Other Identifier: World Health Organization (WHO))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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