A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis
NCT ID: NCT05919082
Last Updated: 2025-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
604 participants
INTERVENTIONAL
2023-06-21
2024-03-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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LEO 90100
The subjects will receive LEO 90100 foam once daily for 4 weeks.
LEO 90100
Subjects will apply LEO 90100 topically; up to 15 g per day (or 105 g per week).
Daivobet® ointment
The subjects will receive Daivobet® ointment once daily for 4 weeks.
Daivobet® ointment
Subjects will apply Daivobet® ointment topically; up to 15 g per day (or 105 g per week).
Interventions
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LEO 90100
Subjects will apply LEO 90100 topically; up to 15 g per day (or 105 g per week).
Daivobet® ointment
Subjects will apply Daivobet® ointment topically; up to 15 g per day (or 105 g per week).
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Expert
Role: STUDY_DIRECTOR
LEO Pharma
Locations
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LEO Pharma Investigational Site
Bengbu, Anhui, China
LEO Pharma Investigational Site
Hefei, Anhui, China
LEO Pharma Investigational Site
Beijing, Beijing Municipality, China
LEO Pharma Investigational Site
Beijing, Beijing Municipality, China
LEO Pharma Investigational Site
Chongqing, Chongqing Municipality, China
LEO Pharma Investigational Site
Chongqing, Chongqing Municipality, China
LEO Pharma Investigational Site
Guangzhou, Guangdong, China
LEO Pharma Investigational Site
Guangzhou, Guangdong, China
LEO Pharma Investigational Site
Shenzhen, Guangdong, China
LEO Pharma Investigational Site
Cangzhou, Hebei, China
LEO Pharma Investigational Site
Chengde, Hebei, China
LEO Pharma Investigational Site
Shijiangzhuang, Hebei, China
LEO Pharma Investigational Site
Nanyang, Henan, China
LEO Pharma Investigational Site
Shiyan, Hubei, China
LEO Pharma Investigational Site
Wuhan, Hubei, China
LEO Pharma Investigational Site
Changsha, Hunan, China
LEO Pharma Investigational Site
Baotou, Inner Mongolia, China
LEO Pharma Investigational Site
Baotou, Inner Mongolia, China
LEO Pharma Investigational Site
Hohhot, Inner Mongolia, China
LEO Pharma Investigational Site
Wuxi, Jiangsu, China
LEO Pharma Investigational Site
Yangzhou, Jiangsu, China
LEO Pharma Investigational Site
Zhenjiang, Jiangsu, China
LEO Pharma Investigational Site
Changchun, Jilin, China
LEO Pharma Investigational Site
Xi'an, Shaanxi, China
LEO Pharma Investigational Site
Dongying, Shandong, China
LEO Pharma Investigational Site
Jinan, Shandong, China
LEO Pharma Investigational Site
Jinan, Shandong, China
LEO Pharma Investigational Site
Shanghai, Shanghai Municipality, China
LEO Pharma Investigational Site
Chengdu, Sichuan, China
LEO Pharma Investigational Site
Suining, Sichuan, China
LEO Pharma Investigational Site
Hangzhou, Zhejiang, China
LEO Pharma Investigational Site
Hangzhou, Zhejiang, China
LEO Pharma Investigational Site
Hangzhou, Zhejiang, China
LEO Pharma Investigational Site
Hangzhou, Zhejiang, China
LEO Pharma Investigational Site
Jiaxing, Zhejiang, China
LEO Pharma Investigational Site
Ningbo, Zhejiang, China
LEO Pharma Investigational Site
Ningbo, Zhejiang, China
LEO Pharma Investigational Site
Wenzhou, Zhejiang, China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1285-7764
Identifier Type: OTHER
Identifier Source: secondary_id
LP0053-2277
Identifier Type: -
Identifier Source: org_study_id
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