NCT05919082|CompletedPhase 3Results

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

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

LEO Pharma ClinicalTrials.gov

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2 other identifiers

LP0053-2277U1111-1285-7764

Study Type

interventional

Target

604

Locations

1 country

Sites

Timeline

RegisteredJun 2023

StartedJun 2023

CompletionMar 2024

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

604

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jun 2023

Shorter than P25 for phase_3

Geographic Reach

1 country

38 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9 months study duration

First Submitted

Initial submission to the registry

June 16, 2023

Completed

5 days until next milestone

Study Start

First participant enrolled

June 21, 2023

Completed

5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2024

Completed

11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2024

Completed

1 year until next milestone

Results Posted

Study results publicly available

March 21, 2025

Completed

Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

June 16, 2023

Results QC Date

February 21, 2025

Last Update Submit

March 17, 2025

Conditions

Stable Plaque Psoriasis

Keywords

Stable plaque psoriasisVitamin D analogueNative Chinese subjects

Outcome Measures

Primary Outcomes (1)

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
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.
On Day 29

Secondary Outcomes (3)

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
Percentage of Participants With Decrease in mPASI of at Least 90% (mPASI-90) From Baseline to Day 29
From Baseline to Day 29
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
From Baseline to Day 43

Study Arms (2)

LEO 90100

EXPERIMENTAL

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

Drug: LEO 90100

Daivobet® ointment

ACTIVE COMPARATOR

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

Drug: Daivobet® ointment

Interventions

LEO 90100DRUG

Subjects will apply LEO 90100 topically; up to 15 g per day (or 105 g per week).

LEO 90100

Daivobet® ointmentDRUG

Subjects will apply Daivobet® ointment topically; up to 15 g per day (or 105 g per week).

Daivobet® ointment

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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)
+6 more criteria

Contact the study team to confirm eligibility.