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

March 20, 2026 updated by: LEO Pharma

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
604

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233060
        • LEO Pharma Investigational Site
      • Hefei, Anhui, China, 230022
        • LEO Pharma Investigational Site
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • LEO Pharma Investigational Site
      • Beijing, Beijing Municipality, China, 100050
        • LEO Pharma Investigational Site
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400021
        • LEO Pharma Investigational Site
      • Chongqing, Chongqing Municipality, China, 400042
        • LEO Pharma Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • LEO Pharma Investigational Site
      • Guangzhou, Guangdong, China, 516006
        • LEO Pharma Investigational Site
      • Shenzhen, Guangdong, China, 518020
        • LEO Pharma Investigational Site
    • Hebei
      • Cangzhou, Hebei, China, 061000
        • LEO Pharma Investigational Site
      • Chengde, Hebei, China, 067000
        • LEO Pharma Investigational Site
      • Shijiangzhuang, Hebei, China, 050030
        • LEO Pharma Investigational Site
    • Henan
      • Nanyang, Henan, China, 473004
        • LEO Pharma Investigational Site
    • Hubei
      • Shiyan, Hubei, China, 442000
        • LEO Pharma Investigational Site
      • Wuhan, Hubei, China, 430022
        • LEO Pharma Investigational Site
    • Hunan
      • Changsha, Hunan, China, 410011
        • LEO Pharma Investigational Site
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014010
        • LEO Pharma Investigational Site
      • Baotou, Inner Mongolia, China, 014016
        • LEO Pharma Investigational Site
      • Hohhot, Inner Mongolia, China, 010000
        • LEO Pharma Investigational Site
    • Jiangsu
      • Wuxi, Jiangsu, China, 214002
        • LEO Pharma Investigational Site
      • Yangzhou, Jiangsu, China, 225003
        • LEO Pharma Investigational Site
      • Zhenjiang, Jiangsu, China, 212001
        • LEO Pharma Investigational Site
    • Jilin
      • Changchun, Jilin, China, 130021
        • LEO Pharma Investigational Site
    • Shaanxi
      • Xi'an, Shaanxi, China, 510080
        • LEO Pharma Investigational Site
    • Shandong
      • Dongying, Shandong, China, 257099
        • LEO Pharma Investigational Site
      • Jinan, Shandong, China, 250013
        • LEO Pharma Investigational Site
      • Jinan, Shandong, China, 250022
        • LEO Pharma Investigational Site
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200443
        • LEO Pharma Investigational Site
    • Sichuan
      • Chengdu, Sichuan, China, 610044
        • LEO Pharma Investigational Site
      • Suining, Sichuan, China, 629000
        • LEO Pharma Investigational Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • LEO Pharma Investigational Site
      • Hangzhou, Zhejiang, China, 310009
        • LEO Pharma Investigational Site
      • Hangzhou, Zhejiang, China, 310014
        • LEO Pharma Investigational Site
      • Hangzhou, Zhejiang, China, 310016
        • LEO Pharma Investigational Site
      • Jiaxing, Zhejiang, China, 314001
        • LEO Pharma Investigational Site
      • Ningbo, Zhejiang, China, 315010
        • LEO Pharma Investigational Site
      • Ningbo, Zhejiang, China, 315016
        • LEO Pharma Investigational Site
      • Wenzhou, Zhejiang, China, 325000
        • LEO Pharma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LEO 90100
The subjects will receive LEO 90100 foam once daily for 4 weeks.
Drug: LEO 90100
Subjects will apply LEO 90100 topically; up to 15 g per day (or 105 g per week).
Active Comparator: Daivobet® ointment
The subjects will receive Daivobet® ointment once daily for 4 weeks.
Drug: Daivobet® ointment
Subjects will apply Daivobet® ointment topically; up to 15 g per day (or 105 g per week).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
On Day 29

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Decrease in Modified Psoriasis Area and Severity Index of at Least 75% (mPASI-75) From Baseline to Day 29
Time Frame: 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.
From Baseline to Day 29
Percentage of Participants With Decrease in mPASI of at Least 90% (mPASI-90) From Baseline to Day 29
Time Frame: 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.
From Baseline to Day 29
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: 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.
From Baseline to Day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LEO Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Expert, LEO Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LP0053-2277
  • U1111-1285-7764 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Sharing Access Criteria

De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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