Stable Plaque PsoriasisPhase 3NCT05919082
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 study testing LEO 90100 and Daivobet® ointment in people with Stable Plaque Psoriasis, run by LEO Pharma at 38 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Plaque Psoriasis
- What is being tested?
- LEO 90100 and Daivobet® ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 604 participants
- Where
- 38 sitesChina
- Study dates
- 21 Jun 2023to 5 Mar 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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 locations and contacts
38 sites in 1 country.
38 sites in 1 country
China38 sites
LEO Pharma Investigational Site
Baotou, Inner Mongolia, 014010
LEO Pharma Investigational Site
Baotou, Inner Mongolia, 014016
LEO Pharma Investigational Site
Beijing, Beijing Municipality, 100044
LEO Pharma Investigational Site
Beijing, Beijing Municipality, 100050
LEO Pharma Investigational Site
Bengbu, Anhui, 233060
LEO Pharma Investigational Site
Cangzhou, Hebei, 061000
LEO Pharma Investigational Site
Changchun, Jilin, 130021
LEO Pharma Investigational Site
Changsha, Hunan, 410011
LEO Pharma Investigational Site
Chengde, Hebei, 067000
LEO Pharma Investigational Site
Chengdu, Sichuan, 610044
LEO Pharma Investigational Site
Chongqing, Chongqing Municipality, 400021
LEO Pharma Investigational Site
Chongqing, Chongqing Municipality, 400042
LEO Pharma Investigational Site
Dongying, Shandong, 257099
LEO Pharma Investigational Site
Guangzhou, Guangdong, 510080
LEO Pharma Investigational Site
Guangzhou, Guangdong, 516006
LEO Pharma Investigational Site
Hangzhou, Zhejiang, 310003
LEO Pharma Investigational Site
Hangzhou, Zhejiang, 310009
LEO Pharma Investigational Site
Hangzhou, Zhejiang, 310014
LEO Pharma Investigational Site
Hangzhou, Zhejiang, 310016
LEO Pharma Investigational Site
Hefei, Anhui, 230022
LEO Pharma Investigational Site
Hohhot, Inner Mongolia, 010000
LEO Pharma Investigational Site
Jiaxing, Zhejiang, 314001
LEO Pharma Investigational Site
Jinan, Shandong, 250013
LEO Pharma Investigational Site
Jinan, Shandong, 250022
LEO Pharma Investigational Site
Nanyang, Henan, 473004
LEO Pharma Investigational Site
Ningbo, Zhejiang, 315010
LEO Pharma Investigational Site
Ningbo, Zhejiang, 315016
LEO Pharma Investigational Site
Shanghai, Shanghai Municipality, 200443
LEO Pharma Investigational Site
Shenzhen, Guangdong, 518020
LEO Pharma Investigational Site
Shijiangzhuang, Hebei, 050030
LEO Pharma Investigational Site
Shiyan, Hubei, 442000
LEO Pharma Investigational Site
Suining, Sichuan, 629000
LEO Pharma Investigational Site
Wenzhou, Zhejiang, 325000
LEO Pharma Investigational Site
Wuhan, Hubei, 430022
LEO Pharma Investigational Site
Wuxi, Jiangsu, 214002
LEO Pharma Investigational Site
Xi'an, Shaanxi, 510080
LEO Pharma Investigational Site
Yangzhou, Jiangsu, 225003
LEO Pharma Investigational Site
Zhenjiang, Jiangsu, 212001
About this study
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
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.
Read the 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.
- Conditions
- Stable Plaque Psoriasis
- Being tested
- LEO 90100, Daivobet® ointment
- Keywords
- Stable plaque psoriasis, Vitamin D analogue, Native Chinese subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 90100Drug
Subjects will apply LEO 90100 topically; up to 15 g per day (or 105 g per week).
Daivobet® ointmentDrug
Subjects will apply Daivobet® ointment topically; up to 15 g per day (or 105 g per week).
| Study group | Role | What they receive |
|---|---|---|
| LEO 90100 | Experimental | The subjects will receive LEO 90100 foam once daily for 4 weeks. Receives: Drug: LEO 90100 |
| Daivobet® ointment | Active comparator | The subjects will receive Daivobet® ointment once daily for 4 weeks. Receives: Drug: Daivobet® ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From Baseline to Day 29
Percentage of Participants With Decrease in mPASI of at Least 90% (mPASI-90) 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.
Measured: From Baseline to Day 29
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
Measured: From Baseline to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start21 Jun 2023
- Primary completion23 Feb 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stable Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919082
- Sponsor's protocol ID
- LP0053-2277
- Other IDs
- U1111-1285-7764
- Status last verified
- Mar 2025
- First submitted
- 16 Jun 2023
- Last updated
- 6 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cai L, Zhang F, Zhang G, Lin B, Huang K, Li Y, Wang J, Wan J, Yin W, Zhang G, Ding Y, Meng Z, Xu A, Li L, Zhu X, Zhou Y, Chen R, Duan X, Yu C, Cheng H, Wang L, Yan M, Pan W, Zhu X, Li Z, Han H, Zhang M, Li S, Diao Q, Tao J, Yan W, Xiao R, Zhang J, Yang B, Qiao J, Man X, Wang Z, Qin L, Lyu X, Jorgensen AEM, Kurvits M, Andersen JS, Zhang J. Superior efficacy and comparable safety of calcipotriol plus betamethasone dipropionate foam vs. ointment in Chinese patients with plaque psoriasis: A randomized phase 3 trial. Chin Med J (Engl). 2026 Mar 17. doi: 10.1097/CM9.0000000000003931. Online ahead of print. No abstract available.
PubMed 41850772Cai L, Zhang F, Zhang G, Ding Y, Zhou Y, Li S, Tao J, Yan W, Xiao R, Yang B, Qiao J, Man X, Wang Z, El Mongy Jorgensen A, Kurvits M, Andersen JS, Zhang J. Rapid Onset of Action and Quality-of-Life Improvements in Chinese Patients with Plaque Psoriasis Treated with Calcipotriol plus Betamethasone Dipropionate Aerosol Foam in a Randomized Phase 3 Trial. Dermatol Ther (Heidelb). 2026 Jun;16(6):3123-3138. doi: 10.1007/s13555-026-01763-5. Epub 2026 May 3.
PubMed 42070197
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05919082
- Acronym / sponsor ID
- LP0053-2277
- Conditions
- Stable Plaque Psoriasis
- Keywords
- Stable plaque psoriasis, Vitamin D analogue, Native Chinese subjects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Posted 21 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEO 90100 | Experimental | Drug: LEO 90100The subjects will receive LEO 90100 foam once daily for 4 weeks. |
| Daivobet® ointment | Active comparator | Drug: Daivobet® ointmentThe subjects will receive Daivobet® ointment once daily for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEO 90100Subjects will apply LEO 90100 topically; up to 15 g per day (or 105 g per week). | Drug | LEO 90100 |
| Daivobet® ointmentSubjects will apply Daivobet® ointment topically; up to 15 g per day (or 105 g per week). | Drug | Daivobet® ointment |
Primary outcome
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.
3 secondary outcomes
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
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
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From Baseline to Day 43
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41850772Cai L, Zhang F, Zhang G, Lin B, Huang K, Li Y, Wang J, Wan J, Yin W, Zhang G, Ding Y, Meng Z, Xu A, Li L, Zhu X, Zhou Y, Chen R, Duan X, Yu C, Cheng H, Wang L, Yan M, Pan W, Zhu X, Li Z, Han H, Zhang M, Li S, Diao Q, Tao J, Yan W, Xiao R, Zhang J, Yang B, Qiao J, Man X, Wang Z, Qin L, Lyu X, Jorgensen AEM, Kurvits M, Andersen JS, Zhang J. Superior efficacy and comparable safety of calcipotriol plus betamethasone dipropionate foam vs. ointment in Chinese patients with plaque psoriasis: A randomized phase 3 trial. Chin Med J (Engl). 2026 Mar 17. doi: 10.1097/CM9.0000000000003931. Online ahead of print. No abstract available.
- Derived from this study: PubMed 42070197Cai L, Zhang F, Zhang G, Ding Y, Zhou Y, Li S, Tao J, Yan W, Xiao R, Yang B, Qiao J, Man X, Wang Z, El Mongy Jorgensen A, Kurvits M, Andersen JS, Zhang J. Rapid Onset of Action and Quality-of-Life Improvements in Chinese Patients with Plaque Psoriasis Treated with Calcipotriol plus Betamethasone Dipropionate Aerosol Foam in a Randomized Phase 3 Trial. Dermatol Ther (Heidelb). 2026 Jun;16(6):3123-3138. doi: 10.1007/s13555-026-01763-5. Epub 2026 May 3.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Expert study director
LEO Pharma
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LEO 90100 and Daivobet® ointment in people with Stable Plaque Psoriasis, run by LEO Pharma at 38 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05919082, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.