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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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The purpose of this study is to obtain preliminary data regarding the safety and tolerability of apremilast in AD to support the design of larger controlled studies.
To investigate the preliminary safety and efficacy of apremilast, an oral phosphodiesterase 4 inhibitor, for atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 mg BID | Experimental | Patients dosed with 20 mg orally of Apremilast BID for 3 months. |
|
| 30 mg BID | Experimental | Patients dosed with 30 mg orally of Apremilast BID for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast | Drug | 20mg of Apremilast taken orally BID for 3 months or 30 mg of Apremilast taken orally BID for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in EASI Scores | The eczema area and severity index (EASI) is a composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The component measuring area is a body surface area measurement of each region. The area and severity of each body region is weighted based on size of region which are added together for the complete score. The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. In this study the change in EASI score between baseline and month three (end of study) in the 20 mg arm and month six in the 30 mg arm, baseline EASI score was subtracted from month 3 or month 6 score in the 30mg arm,and calculated as a final outcome data point. | Mean change in EASI score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Each IGA Category | The investigator global assessment scale is a gestalt global assessment made by an investigator describing the overall disease severity of the patient. It is a categorical scale that includes 0-clear, 1-almost clear, 2-mild,3- moderate, 4-severe, and 5-very severe. The reduction in IGA score from baseline to month three (end of study) in the 20mg arm and month six (end of study) in the 30mg arm was evaluated for efficacy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric L Simpson, MD, MCR | Oregon Health and Science University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22508772 | Derived | Samrao A, Berry TM, Goreshi R, Simpson EL. A pilot study of an oral phosphodiesterase inhibitor (apremilast) for atopic dermatitis in adults. Arch Dermatol. 2012 Aug;148(8):890-7. doi: 10.1001/archdermatol.2012.812. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Apremilast 20mg | Apremilast: 20 mg by mouth twice daily for a total of 12 weeks. |
| FG001 | Apremilast 30mg | Apremilast: 30 mg by mouth twice daily for a total of 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Apremilast 20mg | Apremilast: 20 mg by mouth twice daily for a total of 12 weeks. |
| BG001 | Apremilast 30mg | Apremilast: 30 mg by mouth twice daily for a total of 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Change in EASI Scores | The eczema area and severity index (EASI) is a composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The component measuring area is a body surface area measurement of each region. The area and severity of each body region is weighted based on size of region which are added together for the complete score. The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. In this study the change in EASI score between baseline and month three (end of study) in the 20 mg arm and month six in the 30 mg arm, baseline EASI score was subtracted from month 3 or month 6 score in the 30mg arm,and calculated as a final outcome data point. | Posted | Mean | Standard Deviation | units on a scale | Mean change in EASI score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm) |
|
4 Months in the 20 mg BID arm, and 7 months in the 30mg BID arm.
All-cause mortality was not monitored/assessed.
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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 | Apremalist 20mg BID | Patients receiving 20mg BID for 12 weeks | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Simpson, | Oregon Health & Science University | 503-494-2121 | simpsone@ohsu.edu |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C505730 | apremilast |
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20mg cohort enrolled and completed before the 30mg cohort enrolled.
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| Mean change in IGA score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm) |
| Change in Pruritus (Visual Analog Scale) Score | The pruritus visual analog scale (VAS) is a 10 cm (100 mm) visual analog scale that measures up patient's itch severity with 10 (100 mm) representing the worst imaginable and 0 representing no itch. This is a validated scale with a change of three from baseline to month three in the 20mg arm (end of study) and month six in the 30mg arm (end of study) being clinically relevant. | Mean change in Pruritus (Visual Analog Scale) score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm) |
| Change In DLQI Scores | The dermatology life quality index (DLQI) is a validated quality-of-life scale that measures the impact of skin disease. It is a 10 question instrument. Scores of 0 over 0-1 means there is no effect on the patient's life. Scores between 2 and 5 represent a small effect on patient's life. Scores between 6 and 10 correspond to a moderate effect on patient's life. Scores between 11 and 20 correspond to a very large effect on the patient's life. And scores between 21 and 30 correspond to an extremely large effect on patient's life. The range of the scale between 0 and 30 for the added total of the patient's responses. Each question can be answered on a scale of 0-"not at all", 1-"a little", 2-" a lot", 3- "very much" with some questions having the option of "not relevant". The difference in DLQI score from baseline to month three (end of study) in the 20mg arm and month six (end of study) in the 30mg arm was evaluated for efficacy. | Mean change in DLQI scores measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| EASI | The eczema area and severity index (EASI) is a validated composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four symptoms of eczema: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. | Mean | Standard Deviation | units on a scale |
|
| Description |
|---|
| OG000 | Apremilast 20 BID | Subjects received 20mg of Apremilast BID for 12 weeks |
| OG001 | Apremilast 30mg BID | Subjects received 30mg of Apremilast BID for 24 weeks |
|
|
| Secondary | Number of Participants in Each IGA Category | The investigator global assessment scale is a gestalt global assessment made by an investigator describing the overall disease severity of the patient. It is a categorical scale that includes 0-clear, 1-almost clear, 2-mild,3- moderate, 4-severe, and 5-very severe. The reduction in IGA score from baseline to month three (end of study) in the 20mg arm and month six (end of study) in the 30mg arm was evaluated for efficacy. | Posted | Number | participants | Mean change in IGA score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm) |
|
|
|
| Secondary | Change in Pruritus (Visual Analog Scale) Score | The pruritus visual analog scale (VAS) is a 10 cm (100 mm) visual analog scale that measures up patient's itch severity with 10 (100 mm) representing the worst imaginable and 0 representing no itch. This is a validated scale with a change of three from baseline to month three in the 20mg arm (end of study) and month six in the 30mg arm (end of study) being clinically relevant. | Posted | Mean | Standard Deviation | units on a scale | Mean change in Pruritus (Visual Analog Scale) score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm) |
|
|
|
| Secondary | Change In DLQI Scores | The dermatology life quality index (DLQI) is a validated quality-of-life scale that measures the impact of skin disease. It is a 10 question instrument. Scores of 0 over 0-1 means there is no effect on the patient's life. Scores between 2 and 5 represent a small effect on patient's life. Scores between 6 and 10 correspond to a moderate effect on patient's life. Scores between 11 and 20 correspond to a very large effect on the patient's life. And scores between 21 and 30 correspond to an extremely large effect on patient's life. The range of the scale between 0 and 30 for the added total of the patient's responses. Each question can be answered on a scale of 0-"not at all", 1-"a little", 2-" a lot", 3- "very much" with some questions having the option of "not relevant". The difference in DLQI score from baseline to month three (end of study) in the 20mg arm and month six (end of study) in the 30mg arm was evaluated for efficacy. | Posted | Mean | Standard Deviation | units on a scale | Mean change in DLQI scores measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm) |
|
|
|
| 0 |
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | Apremalist 30mg BID | Patients receiving 30mg BID for 24 weeks | 0 | 0 | 0 | 10 | 9 | 10 |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Severe |
|
| Very Severe |
|