Stable Plaque Psoriasis
Conditions
Keywords
Stable plaque psoriasis, Vitamin D analogue, Native Chinese subjects
Brief 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.
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.
Interventions
DRUGLEO 90100
Subjects will apply LEO 90100 topically; up to 15 g per day (or 105 g per week).
Subjects will apply Daivobet® ointment topically; up to 15 g per day (or 105 g per week).
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
China
Participant flow
Recruitment details
This study was conducted at 39 sites that enrolled participants in China from 21 June 2023 to 05 March 2024.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| LEO 90100 The participants received up to 15 g LEO 90100 foam once daily for 4 weeks. | 302 |
| Daivobet Ointment The participants received up to 15 g Daivobet® ointment once daily for 4 weeks. | 302 |
| Total | 604 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Investigator Decision | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 9 |
Baseline characteristics
| Characteristic | LEO 90100 | Daivobet Ointment | Total |
|---|---|---|---|
| Age, Continuous | 45.9 years STANDARD_DEVIATION 13.45 | 45.7 years STANDARD_DEVIATION 13.07 | 45.8 years STANDARD_DEVIATION 13.25 |
| Age, Customized <=18 years | 0 Participants | 3 Participants | 3 Participants |
| Age, Customized >=65 years | 29 Participants | 23 Participants | 52 Participants |
| Age, Customized Between 18 and 65 years | 273 Participants | 276 Participants | 549 Participants |
| Race/Ethnicity, Customized Chinese | 302 Participants | 302 Participants | 604 Participants |
| Sex: Female, Male Female | 78 Participants | 88 Participants | 166 Participants |
| Sex: Female, Male Male | 224 Participants | 214 Participants | 438 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 300 | 0 / 301 |
| other Total, other adverse events | 53 / 300 | 39 / 301 |
| serious Total, serious adverse events | 4 / 300 | 0 / 301 |
Outcome results
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.
Time frame: On Day 29
Population: All randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEO 90100 | 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 | 50.0 Percentage of Participants |
| Daivobet® 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 Baseline | 42.4 Percentage of Participants |
p-value: 0.043895% CI: [1.01, 1.99]Regression, Logistic
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.
Time frame: From Baseline to Day 43
Population: All participants who are exposed to the IMP. Participants were analyzed according to the treatment they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEO 90100 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any TEAE | 77 Participants |
| LEO 90100 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Leading to Deaths | 0 Participants |
| LEO 90100 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Serious | 4 Participants |
| LEO 90100 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Non-Serious | 75 Participants |
| LEO 90100 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Leading to Permanent Discontinuation from investigational medicinal product (IMP) | 3 Participants |
| LEO 90100 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Leading to Withdrawals from the Trial | 3 Participants |
| Daivobet® Ointment | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Leading to Permanent Discontinuation from investigational medicinal product (IMP) | 0 Participants |
| Daivobet® Ointment | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any TEAE | 68 Participants |
| Daivobet® Ointment | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Non-Serious | 68 Participants |
| Daivobet® Ointment | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Leading to Deaths | 0 Participants |
| Daivobet® Ointment | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Leading to Withdrawals from the Trial | 0 Participants |
| Daivobet® Ointment | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Serious | 0 Participants |
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.
Time frame: From Baseline to Day 29
Population: All randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEO 90100 | Percentage of Participants With Decrease in Modified Psoriasis Area and Severity Index of at Least 75% (mPASI-75) From Baseline to Day 29 | 63.6 Percentage of Participants |
| Daivobet® Ointment | Percentage of Participants With Decrease in Modified Psoriasis Area and Severity Index of at Least 75% (mPASI-75) From Baseline to Day 29 | 53.6 Percentage of Participants |
p-value: 0.010895% CI: [1.1, 2.12]Regression, Logistic
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.
Time frame: From Baseline to Day 29
Population: All randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEO 90100 | Percentage of Participants With Decrease in mPASI of at Least 90% (mPASI-90) From Baseline to Day 29 | 33.1 Percentage of Participants |
| Daivobet® Ointment | Percentage of Participants With Decrease in mPASI of at Least 90% (mPASI-90) From Baseline to Day 29 | 24.5 Percentage of Participants |
p-value: 0.019995% CI: [1.07, 2.19]Regression, Logistic