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| Name | Class |
|---|---|
| CMIC Co, Ltd. Japan | INDUSTRY |
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To compare the efficacy and safety of LEO 80185 gel with Dovobet® ointment in the treatment of psoriasis in Japanese subjects.
A phase 3, national, multi-centre, 4-week, prospective, randomised, controlled, parallel-group, open trial of LEO 80185 gel versus Dovobet® ointment in Japanese subjects with psoriasis vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 80185 gel | Experimental |
| |
| Dovobet ® ointment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 80185 gel | Drug | calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With 'Overall Improvement' for the Target Lesion on the Scalp | 'Overall improvement' for the target lesion on the scalp, defined as 'substantial resolution' of clinical signs and/or at least 'moderately improved' in the general change in the lesion. 'Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the lesion. | End of Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With 'Overall Improvement' for the Target Lesion on the Non-scalp Area of the Body | 'Overall Improvement' for the target lesion on the non-scalp area of the body, defined as 'substantial resolution' of clinical signs and/or at least 'moderately improved' in the general change in the lesion. 'Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the lesion. |
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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 |
|---|---|---|---|---|---|---|
| Medical Corporation Bikyukai Kokubu Dermatology | Kitami-shi | Hokkaido | 090-0832 | Japan |
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| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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The trial had 213 participants enrolled and 206 participants randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | LEO 80185 Gel | LEO 80185 gel: calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions |
| FG001 | Dovobet® Ointment | Dovobet® ointment: calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LEO 80185 Gel | LEO 80185 gel: calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions |
| BG001 | Dovobet® Ointment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Subjects With 'Overall Improvement' for the Target Lesion on the Scalp | 'Overall improvement' for the target lesion on the scalp, defined as 'substantial resolution' of clinical signs and/or at least 'moderately improved' in the general change in the lesion. 'Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the lesion. | All 206 randomised subjects are included in the full analysis set (FAS): 101 in the LEO 80185 group and 105 in the Dovobet® group. The per protocol analysis set (PPAS) was defined by excluding subjects from the FAS based on a review of protocol deviations. PPAS includes 94 subjects in the LEO 80185 group and 100 in the Dovobet® group. | Posted | Count of Participants | Participants | End of Week 4 |
|
From signing of Informed Consent Form up to 14 days after last visit (Week 4).
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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 80185 Gel | LEO 80185 gel: calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meningitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | LEO Pharma A/S | disclosure@leo-pharma.com |
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| Dovobet ® ointment | Drug | calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions |
|
| End of Week 4 |
| The Change in the Sum of the Scores (Total Sign Score) for the Severity of the 3 Clinical Signs:Thickness, Scaliness, Redness From Baseline to End of Week 4 (Visit 1-4) for Each Target Lesion. | Severity was recorded for each of the 3 clinical signs according to the 9-point scales* below. *intermediate intervals (0.5, 1.5, 2.5, 3.5) serve as mid points between the defined grades. Redness 0=none (no erythema)
Thickness 0=none (no plaque elevation)
Scaliness 0=none (no scaling)
Negative change denotes a decrease in the score and therefore a decrease in disease severity. | From Baseline to end of Week 4 (Visit 1-4) |
Dovobet® ointment: calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Dovobet® Ointment | Dovobet® ointment: calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions |
|
|
|
| Secondary | Number of Subjects With 'Overall Improvement' for the Target Lesion on the Non-scalp Area of the Body | 'Overall Improvement' for the target lesion on the non-scalp area of the body, defined as 'substantial resolution' of clinical signs and/or at least 'moderately improved' in the general change in the lesion. 'Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the lesion. | All 206 randomised subjects are included in the full analysis set (FAS): 101 in the LEO 80185 group and 105 in the Dovobet® group. The per protocol analysis set (PPAS) was defined by excluding subjects from the FAS based on a review of protocol deviations. PPAS includes 94 subjects in the LEO 80185 group and 100 in the Dovobet® group. | Posted | Count of Participants | Participants | End of Week 4 |
|
|
|
|
| Secondary | The Change in the Sum of the Scores (Total Sign Score) for the Severity of the 3 Clinical Signs:Thickness, Scaliness, Redness From Baseline to End of Week 4 (Visit 1-4) for Each Target Lesion. | Severity was recorded for each of the 3 clinical signs according to the 9-point scales* below. *intermediate intervals (0.5, 1.5, 2.5, 3.5) serve as mid points between the defined grades. Redness 0=none (no erythema)
Thickness 0=none (no plaque elevation)
Scaliness 0=none (no scaling)
Negative change denotes a decrease in the score and therefore a decrease in disease severity. | The per protocol analysis set (PPAS) was defined by excluding subjects from the full analysis set (FAS) based on a review of protocol deviations. PPAS includes 94 subjects in the LEO 80185 group and 100 in the Dovobet® group. | Posted | Mean | Standard Deviation | Scores on a scale | From Baseline to end of Week 4 (Visit 1-4) |
|
|
|
| 0 |
| 101 |
| 1 |
| 101 |
| 13 |
| 101 |
| EG001 | Dovobet® Ointment | Dovobet® ointment: calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions | 0 | 105 | 0 | 105 | 9 | 105 |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Chelitis | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Kaposi's varicelliform eruption | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Ophthalmic herpes simplex | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Alopecia areata | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
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| =0.003 |
Treatment comparison by Fisher's exact test. |
| Odds Ratio (OR) |
| 0.22 |
| 2-Sided |
| 95 |
| 0.08 |
| 0.63 |
Odds of 'overall improvement' in LEO 80185 gel group relative to Dovobet® ointment group. |
| Superiority |