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
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stable Plaque Psoriasis
Keywords: Stable plaque psoriasis
Vitamin D analogue
Native Chinese subjects
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2023-06-26
Enrollment: 604
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants With 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
timeFrame: On Day 29
Secondary outcomes:
measure: Percentage of Participants With Decrease in Modified Psoriasis Area and Severity Index of at Least 75% (mPASI-75) From Baseline to Day 29
timeFrame: From Baseline to Day 29
measure: Percentage of Participants With Decrease in mPASI of at Least 90% (mPASI-90) From Baseline to Day 29
timeFrame: From Baseline to Day 29
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From Baseline to Day 43
Other outcomes:
Locations:
city: Bengbu
country: China
facility: LEO Pharma Investigational Site
state: Anhui
city: Hefei
country: China
facility: LEO Pharma Investigational Site
state: Anhui
city: Beijing
country: China
facility: LEO Pharma Investigational Site
state: Beijing
city: Beijing
country: China
facility: LEO Pharma Investigational Site
state: Beijing
city: Chongqing
country: China
facility: LEO Pharma Investigational Site
state: Chongqing
city: Chongqing
country: China
facility: LEO Pharma Investigational Site
state: Chongqing
city: Guangzhou
country: China
facility: LEO Pharma Investigational Site
state: Guangdong
city: Guangzhou
country: China
facility: LEO Pharma Investigational Site
state: Guangdong
city: Shenzhen
country: China
facility: LEO Pharma Investigational Site
state: Guangdong
city: Cangzhou
country: China
facility: LEO Pharma Investigational Site
state: Hebei
city: Chengde
country: China
facility: LEO Pharma Investigational Site
state: Hebei
city: Shijiangzhuang
country: China
facility: LEO Pharma Investigational Site
state: Hebei
city: Nanyang
country: China
facility: LEO Pharma Investigational Site
state: Henan
city: Shiyan
country: China
facility: LEO Pharma Investigational Site
state: Hubei
city: Wuhan
country: China
facility: LEO Pharma Investigational Site
state: Hubei
city: Changsha
country: China
facility: LEO Pharma Investigational Site
state: Hunan
city: Baotou
country: China
facility: LEO Pharma Investigational Site
state: Inner Mongolia
city: Baotou
country: China
facility: LEO Pharma Investigational Site
state: Inner Mongolia
city: Hohhot
country: China
facility: LEO Pharma Investigational Site
state: Inner Mongolia
city: Wuxi
country: China
facility: LEO Pharma Investigational Site
state: Jiangsu
city: Yangzhou
country: China
facility: LEO Pharma Investigational Site
state: Jiangsu
city: Zhenjiang
country: China
facility: LEO Pharma Investigational Site
state: Jiangsu
city: Changchun
country: China
facility: LEO Pharma Investigational Site
state: Jilin
city: Xi'an
country: China
facility: LEO Pharma Investigational Site
state: Shaanxi
city: Dongying
country: China
facility: LEO Pharma Investigational Site
state: Shandong
city: Jinan
country: China
facility: LEO Pharma Investigational Site
state: Shandong
city: Jinan
country: China
facility: LEO Pharma Investigational Site
state: Shandong
city: Shanghai
country: China
facility: LEO Pharma Investigational Site
state: Shanghai
city: Chengdu
country: China
facility: LEO Pharma Investigational Site
state: Sichuan
city: Suining
country: China
facility: LEO Pharma Investigational Site
state: Sichuan
city: Hangzhou
country: China
facility: LEO Pharma Investigational Site
state: Zhejiang
city: Hangzhou
country: China
facility: LEO Pharma Investigational Site
state: Zhejiang
city: Hangzhou
country: China
facility: LEO Pharma Investigational Site
state: Zhejiang
city: Hangzhou
country: China
facility: LEO Pharma Investigational Site
state: Zhejiang
city: Jiaxing
country: China
facility: LEO Pharma Investigational Site
state: Zhejiang
city: Ningbo
country: China
facility: LEO Pharma Investigational Site
state: Zhejiang
city: Ningbo
country: China
facility: LEO Pharma Investigational Site
state: Zhejiang
city: Wenzhou
country: China
facility: LEO Pharma Investigational Site
state: Zhejiang
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: