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

Phase 3

Completed

Conditions: Stable Plaque Psoriasis

Interventions: Drug: LEO 90100
Drug: Daivobet® ointment

Registration Number: NCT05919082

Lead Sponsor: LEO Pharma

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 604

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEO 90100	LEO 90100	The subjects will receive LEO 90100 foam once daily for 4 weeks.
Daivobet® ointment	Daivobet® ointment	The subjects will receive Daivobet® ointment once daily for 4 weeks.

Primary Outcome Measures

Name	Time	Method
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	On Day 29	The efficacy of LEO 90100 compared with Daivobet® ointment on severity and extent of stable plaque psoriasis was evaluated. 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. Higher score showed worse outcome.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Decrease in Modified Psoriasis Area and Severity Index of at Least 75% (mPASI-75) From Baseline to Day 29	From Baseline to Day 29	The efficacy of LEO 90100 compared with Daivobet® ointment on severity and extent of stable plaque psoriasis was evaluated. 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.
Percentage of Participants With Decrease in mPASI of at Least 90% (mPASI-90) From Baseline to Day 29	From Baseline to Day 29	The efficacy of LEO 90100 compared with Daivobet® ointment on severity and extent of stable plaque psoriasis was evaluated. 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 Participants With Treatment-emergent Adverse Events (TEAEs)	From Baseline to Day 43	The safety of LEO 90100 compared with Daivobet® ointment treating stable plaque psoriasis was evaluated. Only treatment emergent adverse events (TEAEs) have been reported for this outcome measure. An event was considered treatment-emergent if it started after the first investigational medicinal product (IMP) administration or if it started before the first IMP administration and worsened in severity after the first IMP administration.