Trial · NCT05919082
A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis
NCT05919082, Phase 3, Completed, LEO Pharma; results first posted 2025-03-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis. Trials, record NCT05919082. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05919082
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis
- NCT number
- NCT05919082
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 604 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Stable Plaque Psoriasis
- Interventions
- LEO 90100, Daivobet® ointment
- First posted
- 2023-06-26
- Last updated
- 2026-04-06
- Results first posted
- 2025-03-21
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | Percentage of Participants With Decrease in mPASI of at Least 90% (mPASI-90) From Baseline to Day 29 | 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. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | On Day 29 | All randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | 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 | All randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Decrease in mPASI of at Least 90% (mPASI-90) From Baseline to Day 29 | From Baseline to Day 29 | All randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From Baseline to Day 43 | All participants who are exposed to the IMP. Participants were analyzed according to the treatment they actually received. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | LEO 90100 | 50.0 | 95% Confidence Interval 44.36 to 55.64 | 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 | Daivobet® Ointment | 42.4 | 95% Confidence Interval 36.81 to 47.96 | 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 | LEO 90100 | 63.6 | 95% Confidence Interval 58.15 to 69.00 | 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 | Daivobet® Ointment | 53.6 | 95% Confidence Interval 48.02 to 59.27 | Percentage of Participants | |
| Percentage of Participants With Decrease in mPASI of at Least 90% (mPASI-90) From Baseline to Day 29 | LEO 90100 | 33.1 | 95% Confidence Interval 27.80 to 38.42 | Percentage of Participants | |
| Percentage of Participants With Decrease in mPASI of at Least 90% (mPASI-90) From Baseline to Day 29 | Daivobet® Ointment | 24.5 | 95% Confidence Interval 19.65 to 29.35 | Percentage of Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | LEO 90100 | Any TEAE | 77 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Daivobet Ointment | Any TEAE | 68 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | LEO 90100 | Leading to Deaths | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Daivobet Ointment | Leading to Deaths | 0 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LEO 90100 | 302 | |
| Overall Study | STARTED | Daivobet Ointment | 302 | |
| Overall Study | COMPLETED | LEO 90100 | 290 | |
| Overall Study | COMPLETED | Daivobet Ointment | 291 | |
| Overall Study | NOT COMPLETED | LEO 90100 | 12 | |
| Overall Study | NOT COMPLETED | Daivobet Ointment | 11 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | LEO 90100 | 14 | 300 | 14 |
| other | Upper respiratory tract infection | Infections and infestations | Daivobet Ointment | 18 | 301 | 18 |
| other | Folliculitis | Infections and infestations | LEO 90100 | 7 | 300 | 7 |
| other | Folliculitis | Infections and infestations | Daivobet Ointment | 4 | 301 | 4 |
| other | Tinea versicolour | Infections and infestations | LEO 90100 | 4 | 300 | 4 |
| other | Tinea versicolour | Infections and infestations | Daivobet Ointment | 3 | 301 | 3 |
| other | Fungal infection | Infections and infestations | LEO 90100 | 3 | 300 | 3 |
| other | Fungal infection | Infections and infestations | Daivobet Ointment | 0 | 301 | 0 |
| other | Cortisol decreased | Investigations | LEO 90100 | 7 | 300 | 7 |
| other | Cortisol decreased | Investigations | Daivobet Ointment | 6 | 301 | 6 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LEO 90100 | 0 | 300 |
| Total, all-cause mortality | Daivobet Ointment | 0 | 301 |
| Total, other adverse events | LEO 90100 | 53 | 300 |
| Total, other adverse events | Daivobet Ointment | 39 | 301 |
| Total, serious adverse events | LEO 90100 | 4 | 300 |
| Total, serious adverse events | Daivobet Ointment | 0 | 301 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| LEO 90100 vs Daivobet Ointment: deaths from any cause | Trial comparisons |
| LEO 90100 vs Daivobet Ointment: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05919082
GET https://conductscience.org/api/trials/v1/NCT05919082/events?page=2