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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1285-7764 | Other Identifier | World Health Organization (WHO) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 90100 | Experimental | The subjects will receive LEO 90100 foam once daily for 4 weeks. |
|
| Daivobet® ointment | Active Comparator | The subjects will receive Daivobet® ointment once daily for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 90100 | Drug | Subjects will apply LEO 90100 topically; up to 15 g per day (or 105 g per week). |
|
| 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 | 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 |
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEO Pharma Investigational Site | Bengbu | Anhui | 233060 | China | ||
| LEO Pharma Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41850772 | Result | 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. | |
| 42070197 |
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Participants who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment.
This study was conducted at 39 sites that enrolled participants in China from 21 June 2023 to 05 March 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | LEO 90100 | The participants received up to 15 g LEO 90100 foam once daily for 4 weeks. |
| FG001 | Daivobet Ointment | The participants received up to 15 g Daivobet® ointment once daily for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 9, 2022 | Dec 17, 2024 |
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| Daivobet® ointment | Drug | Subjects will apply Daivobet® ointment topically; up to 15 g per day (or 105 g per week). |
|
| 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. | 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. | From Baseline to Day 43 |
| 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 |
| Derived |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | LEO 90100 | The participants received up to 15 g LEO 90100 foam once daily for 4 weeks. |
| BG001 | Daivobet Ointment | The participants received up to 15 g Daivobet® ointment once daily for 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of Participants | On Day 29 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Baseline to Day 29 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Baseline to Day 29 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All participants who are exposed to the IMP. Participants were analyzed according to the treatment they actually received. | Posted | Count of Participants | Participants | From Baseline to Day 43 |
|
|
Up to 10 weeks in total
All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received.
All the TEAEs that were accounted throughout the study have been included in this section.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LEO 90100 | The participants received up to 15 g LEO 90100 foam once daily for 4 weeks. | 0 | 300 | 4 | 300 | 53 | 300 |
| EG001 | Daivobet Ointment | The participants received up to 15 g Daivobet® ointment once daily for 4 weeks. | 0 | 301 | 0 | 301 | 39 | 301 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Cortisol decreased | Investigations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Urine calcium/creatinine ratio increased | Investigations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Application site pain | General disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Application site paraesthesia | General disorders | MedDRA (26.1) | Non-systematic Assessment |
|
The sponsor seeks publication of all clinical trials in peer-reviewed journals within 12 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 12 months, the investigator has the right to publish the results from clinical trial generated by him/herself.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure | LEO Pharma | +45 44945888 | disclosure@leo-pharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 29, 2024 | Dec 18, 2024 | SAP_001.pdf |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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