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

Stable Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05919082
• Other study ID #: LP0053-2277
• Secondary ID: U1111-1285-7764
• Status: Completed
• Phase: Phase 3
• Start date: June 21, 2023
• Est. completion date: March 5, 2024

Study information

• Verified date: April 2024
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: March 5, 2024
• Est. primary completion date: February 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Stable Plaque Psoriasis

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
China	LEO Pharma Investigational Site	Baotou	Inner Mongolia
China	LEO Pharma Investigational Site	Baotou	Inner Mongolia
China	LEO Pharma Investigational Site	Beijing	Beijing
China	LEO Pharma Investigational Site	Beijing	Beijing
China	LEO Pharma Investigational Site	Bengbu	Anhui
China	LEO Pharma Investigational Site	Cangzhou	Hebei
China	LEO Pharma Investigational Site	Changchun	Jilin
China	LEO Pharma Investigational Site	Changsha	Hunan
China	LEO Pharma Investigational Site	Chengde	Hebei
China	LEO Pharma Investigational Site	Chengdu	Sichuan
China	LEO Pharma Investigational Site	Chongqing	Chongqing
China	LEO Pharma Investigational Site	Chongqing	Chongqing
China	LEO Pharma Investigational Site	Dongying	Shandong
China	LEO Pharma Investigational Site	Guangzhou	Guangdong
China	LEO Pharma Investigational Site	Guangzhou	Guangdong
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	Hefei	Anhui
China	LEO Pharma Investigational Site	Hohhot	Inner Mongolia
China	LEO Pharma Investigational Site	Jiaxing	Zhejiang
China	LEO Pharma Investigational Site	Jinan	Shandong
China	LEO Pharma Investigational Site	Jinan	Shandong
China	LEO Pharma Investigational Site	Nanyang	Henan
China	LEO Pharma Investigational Site	Ningbo	Zhejiang
China	LEO Pharma Investigational Site	Ningbo	Zhejiang
China	LEO Pharma Investigational Site	Shanghai	Shanghai
China	LEO Pharma Investigational Site	Shenzhen	Guangdong
China	LEO Pharma Investigational Site	Shijiangzhuang	Hebei
China	LEO Pharma Investigational Site	Shiyan	Hubei
China	LEO Pharma Investigational Site	Suining	Sichuan
China	LEO Pharma Investigational Site	Wenzhou	Zhejiang
China	LEO Pharma Investigational Site	Wuhan	Hubei
China	LEO Pharma Investigational Site	Wuxi	Jiangsu
China	LEO Pharma Investigational Site	Xi'an	Shaanxi
China	LEO Pharma Investigational Site	Yangzhou	Jiangsu
China	LEO Pharma Investigational Site	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to Day 29
Secondary	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.	From baseline to Day 29
Secondary	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.	From baseline to Day 29
Secondary	Number of subjects with treatment-emergent adverse events (TEAEs)		From baseline to Day 43