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CompletedNCT05919082Updated Apr 6, 2026Results posted

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 interventional study of LEO 90100 and Daivobet® ointment in Stable Plaque Psoriasis, sponsored by LEO Pharma. Completed at 38 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by LEO Pharma · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
604
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Stable Plaque Psoriasis

Keywords

  • Stable plaque psoriasis
  • Vitamin D analogue
  • Native Chinese subjects
03

In context

Lead sponsor

LEO Pharma is the lead sponsor of 221 studies on the registry; 5 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
604 participants (actual)

Study arms

  • Experimental
    LEO 90100

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

    Drug: LEO 90100

  • Active comparator
    Daivobet® ointment

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

    Drug: Daivobet® ointment

Interventions

  • DrugLEO 90100

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

  • DrugDaivobet® ointment

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

06

What researchers measure

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.

    Time frame: On Day 29

Secondary outcomes

  1. 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.

    Time frame: From Baseline to Day 29

  2. 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.

    Time frame: From Baseline to Day 29

  3. 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.

    Time frame: From Baseline to Day 43

07

Results

Posted Mar 21, 2025

Participant flow

This study was conducted at 39 sites that enrolled participants in China from 21 June 2023 to 05 March 2024.

Participant flow — Overall Study
MilestoneLEO 90100Daivobet Ointment
Started302302
Completed290291
Not completed1211
Withdrew: Adverse event30
Withdrew: Lost to follow-up01
Withdrew: Withdrawal by subject89
Withdrew: Lack of efficacy01
Withdrew: Investigator decision10

Outcome measures

PrimaryPercentage 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.

Time frame:
On Day 29
Reported as:
Number · Percentage of Participants
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
Percentage of ParticipantsLEO 90100Daivobet® Ointment
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 Baseline50.0 (44.36 to 55.64)42.4 (36.81 to 47.96)
Statistical analysis
  • LEO 90100 vs Daivobet® Ointment · Regression, Logistic · p = 0.0438 · Odds ratio (or): 1.4 · 95% CI 1.01 to 1.99The odds ratio and p-value are obtained by logistic regression model, adjusted for baseline PGA. Wald CI was presented.
SecondaryPercentage 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.

Time frame:
From Baseline to Day 29
Reported as:
Number · Percentage of Participants
Percentage of Participants With Decrease in Modified Psoriasis Area and Severity Index of at Least 75% (mPASI-75) From Baseline to Day 29
Percentage of ParticipantsLEO 90100Daivobet® Ointment
Percentage of Participants With Decrease in Modified Psoriasis Area and Severity Index of at Least 75% (mPASI-75) From Baseline to Day 2963.6 (58.15 to 69.00)53.6 (48.02 to 59.27)
Statistical analysis
  • LEO 90100 vs Daivobet® Ointment · Regression, Logistic · p = 0.0108 · Odds ratio (or): 1.5 · 95% CI 1.10 to 2.12The odds ratio and p-value were obtained by logistic regression model, adjusted for baseline PGA and baseline mPASI score. Wald CI was presented.
SecondaryPercentage 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.

Time frame:
From Baseline to Day 29
Reported as:
Number · Percentage of Participants
Percentage of Participants With Decrease in mPASI of at Least 90% (mPASI-90) From Baseline to Day 29
Percentage of ParticipantsLEO 90100Daivobet® Ointment
Percentage of Participants With Decrease in mPASI of at Least 90% (mPASI-90) From Baseline to Day 2933.1 (27.80 to 38.42)24.5 (19.65 to 29.35)
Statistical analysis
  • LEO 90100 vs Daivobet® Ointment · Regression, Logistic · p = 0.0199 · Odds ratio (or): 1.5 · 95% CI 1.07 to 2.19The odds ratio and p-value were obtained by logistic regression model, adjusted for baseline PGA and baseline mPASI score. Wald CI was presented.
SecondaryNumber 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.

Time frame:
From Baseline to Day 43
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
ParticipantsLEO 90100Daivobet Ointment
Any TEAE7768
Leading to Deaths00
Serious40
Non-Serious7568
Leading to Permanent Discontinuation from investigational medicinal product (IMP)30
Leading to Withdrawals from the Trial30

Adverse events

Collected over Up to 10 weeks in total. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LEO 901000/300 (0%)4/300 (1.3%)53/300 (17.7%)
Daivobet Ointment0/301 (0%)0/301 (0%)39/301 (13%)
Most frequent serious events
Most frequent serious events
EventLEO 90100Daivobet Ointment
Patella fractureInjury, poisoning and procedural complications1/3000/301
Gastrointestinal haemorrhageGastrointestinal disorders1/3000/301
AppendicitisInfections and infestations1/3000/301
PsoriasisSkin and subcutaneous tissue disorders1/3000/301
Most frequent other events
Most frequent other events
EventLEO 90100Daivobet Ointment
Upper respiratory tract infectionInfections and infestations14/30018/301
FolliculitisInfections and infestations7/3004/301
Cortisol decreasedInvestigations7/3006/301
Urine calcium/creatinine ratio increasedInvestigations6/3005/301
Tinea versicolourInfections and infestations4/3003/301
Fungal infectionInfections and infestations3/3000/301
Application site painGeneral disorders3/3001/301
Application site pruritusGeneral disorders3/3001/301
PyrexiaGeneral disorders3/3001/301
Application site paraesthesiaGeneral disorders3/3000/301

Baseline characteristics

Age, Continuous
Age, Continuous(years)LEO 90100Daivobet OintmentTotal
Mean45.9 ± 13.4545.7 ± 13.0745.8 ± 13.25
Age, Customized
Age, Customized(Participants)LEO 90100Daivobet OintmentTotal
<=18 years033
Between 18 and 65 years273276549
>=65 years292352
Sex: Female, Male
Sex: Female, Male(Participants)LEO 90100Daivobet OintmentTotal
Female7888166
Male224214438
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)LEO 90100Daivobet OintmentTotal
Chinese302302604
08

Study locations

38 sites
  • LEO Pharma Investigational Site
    Bengbu, Anhui 233060, China
  • LEO Pharma Investigational Site
    Hefei, Anhui 230022, China
  • LEO Pharma Investigational Site
    Beijing, Beijing Municipality 100044, China
  • LEO Pharma Investigational Site
    Beijing, Beijing Municipality 100050, China
  • LEO Pharma Investigational Site
    Chongqing, Chongqing Municipality 400021, China
  • LEO Pharma Investigational Site
    Chongqing, Chongqing Municipality 400042, China
  • LEO Pharma Investigational Site
    Guangzhou, Guangdong 510080, China
  • LEO Pharma Investigational Site
    Guangzhou, Guangdong 516006, China
  • LEO Pharma Investigational Site
    Shenzhen, Guangdong 518020, China
  • LEO Pharma Investigational Site
    Cangzhou, Hebei 061000, China
  • LEO Pharma Investigational Site
    Chengde, Hebei 067000, China
  • LEO Pharma Investigational Site
    Shijiangzhuang, Hebei 050030, China
  • LEO Pharma Investigational Site
    Nanyang, Henan 473004, China
  • LEO Pharma Investigational Site
    Shiyan, Hubei 442000, China
  • LEO Pharma Investigational Site
    Wuhan, Hubei 430022, China
  • LEO Pharma Investigational Site
    Changsha, Hunan 410011, China
  • LEO Pharma Investigational Site
    Baotou, Inner Mongolia 014010, China
  • LEO Pharma Investigational Site
    Baotou, Inner Mongolia 014016, China
  • LEO Pharma Investigational Site
    Hohhot, Inner Mongolia 010000, China
  • LEO Pharma Investigational Site
    Wuxi, Jiangsu 214002, China
  • LEO Pharma Investigational Site
    Yangzhou, Jiangsu 225003, China
  • LEO Pharma Investigational Site
    Zhenjiang, Jiangsu 212001, China
  • LEO Pharma Investigational Site
    Changchun, Jilin 130021, China
  • LEO Pharma Investigational Site
    Xi'an, Shaanxi 510080, China
  • LEO Pharma Investigational Site
    Dongying, Shandong 257099, China
  • LEO Pharma Investigational Site
    Jinan, Shandong 250013, China
  • LEO Pharma Investigational Site
    Jinan, Shandong 250022, China
  • LEO Pharma Investigational Site
    Shanghai, Shanghai Municipality 200443, China
  • LEO Pharma Investigational Site
    Chengdu, Sichuan 610044, China
  • LEO Pharma Investigational Site
    Suining, Sichuan 629000, China
  • LEO Pharma Investigational Site
    Hangzhou, Zhejiang 310003, China
  • LEO Pharma Investigational Site
    Hangzhou, Zhejiang 310009, China
  • LEO Pharma Investigational Site
    Hangzhou, Zhejiang 310014, China
  • LEO Pharma Investigational Site
    Hangzhou, Zhejiang 310016, China
  • LEO Pharma Investigational Site
    Jiaxing, Zhejiang 314001, China
  • LEO Pharma Investigational Site
    Ningbo, Zhejiang 315010, China
  • LEO Pharma Investigational Site
    Ningbo, Zhejiang 315016, China
  • LEO Pharma Investigational Site
    Wenzhou, Zhejiang 325000, China
09

References and documents

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 41850772 ↗
  • Cai 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 documents

  • Study protocol · Nov 9, 2022
  • Statistical analysis plan · Mar 29, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05919082
Lead sponsor
LEO Pharma
Responsible party
Sponsor
First posted
Jun 26, 2023
Start date
Jun 21, 2023
Primary completion
Feb 23, 2024
Completion
Mar 5, 2024
Results posted
Mar 21, 2025
Last update
Apr 6, 2026

Study contacts

Medical Expert
study director · LEO Pharma

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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