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

LEO Pharma

Status and phase: Completed; Phase 3

Conditions: Stable Plaque Psoriasis

Treatments: Drug: LEO 90100; Drug: Daivobet® ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT05919082

U1111-1285-7764 (Other Identifier)

LP0053-2277

Details and patient eligibility

About

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.

Full 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.

Enrollment: 604 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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604 participants in 2 patient groups

LEO 90100

Experimental group

Description:

The subjects will receive LEO 90100 foam once daily for 4 weeks.

Treatment:

Drug: LEO 90100

Daivobet® ointment

Active Comparator group

Description:

The subjects will receive Daivobet® ointment once daily for 4 weeks.

Treatment:

Drug: Daivobet® ointment