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This study seeks to show whether there is a benefit of prescribing Enstilar with Otezla in the treatment of patients with moderate plaque type psoriasis. Subjects will be randomized to study treatment at a 1:1 ratio of Otezla plus Enstilar foam versus Otezla plus vehicle foam.
Approximately 50 subjects from 4 sites will be enrolled in this investigator-blind study. Subjects will be randomized 1:1 to Otezla plus Enstilar foam or Otezla plus vehicle foam and all adverse events and concomitant medications will be recorded.
Subjects will attend a screening visit/baseline visit and those with plaque-type psoriasis who have been started on commercial Otezla in the last 7 days will be randomized to study treatment as outlined above.
Enstilar or the vehicle will be initiated for the first 4 weeks and then Otezla will be continued as monotherapy for the next 8 weeks. Enstilar or the vehicle will be reinitiated for the last 4 weeks of the study. Total study period is 16 weeks and study visits will occur as follows: screening/baseline, week 1, 2, 3, 4, week 12, and week 16. Study assessments at each visit will be PASI, BSA, PGA, Itch VAS, DLQI, and standard medical assessments. There will be standard medication/treatment and washout periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Otezla plus Enstilar foam | Experimental | Subjects randomized to this group will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily |
|
| Otezla plus vehicle foam | Placebo Comparator | Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enstilar | Drug | Enstilar foam applied to affected areas daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects With a Psoriasis Assessment and Severity Index (PASI) 75 at Week 16 | PASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.) The body is divided into 4 sections: head (10% of total body surface area,) arms (20%,) trunk(30%,) and legs (40%.) Each of these is scored by itself and the 4 scores then combined to obtain thePASI. For each body area, the percent of skin area involved is estimated and graded based on this value (0=0% of area involved, 1=<10%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%.) Within each area, the severity of disease is based on 3 clinical signs: erythema or redness, induration or thickness, and desquamation or scaliness. Each is graded on a scale from 0(none) to 4(maximum.) The sum of all 3 parameters is calculated for each body section, multiplied by the area score for that section and then multiplied by the weight of that section (.1for head, .2 arms, .3 trunk and .4 legs) | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects With PASI 75 at Week 4 and Week 12 | Psoriasis Area & Severity Index (PASI) is a tool used to measure the severity of psoriasis. It combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.) | 4 weeks, 12 weeks |
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Inclusion Criteria:
I. Outpatient, male or female subjects of any race, 18 years of age or higher. Female subjects of childbearing potential must have a (-)UPT (urine pregnancy test) result at within 7 days of the first dose of study drug and practice a reliable method of contraception throughout the study;
A female is considered of childbearing potential unless she is:
- postmenopausal ≥ 5 years of age, without a uterus and/or both ovaries; or has been surgically sterile for ≥ 6 moths.
Reliable methods of contraception are:
- hormonal methods or IUD (intrauterine device) in use ≥ 90 days prior to study drug administration, barrier methods plus spermicide in use ≥ 14 days prior, or vasectomized partner.
[Exception: Female subjects of CBP (child bearing potential) who are not sexually active are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided they are counseled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.] ii. Subjects with moderate plaque type psoriasis who have been started on commercial Otezla within the last 10 days.
iii. Physician Global Assessment (PGA) score of 3. iv. Able to understand study requirements and sign Informed Consent/HIPAA forms.
Exclusion Criteria:
I. Female subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control, or male subjects planning a pregnancy with their spouse or partner while in the study.
ii. History of hypercalcemia or vitamin D toxicity or history of significant renal or hepatic disease iii. Patients with guttate, erythrodermic, or pustular psoriasis iv. Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator).
v. Skin conditions (e.g.eczema) other than psoriasis that may interfere with evaluations of psoriasis.
vi. Known hypersensitivity to Enstilar Foam or any of its components. vii. Current drug or alcohol abuse (Investigator opinion). viii. Subject unable to commit to all the assessments required by the protocol. ix. Current enrollment in another clinical study and treatment with another experimental drug or approved therapy for experimental use within 30 days prior to the Screening Visit.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Dermatology and Laser Surgery | Sacramento | California | 95819 | United States | ||
| Skin Sciences, PLLC |
1 participant signed consent but failed screening
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| ID | Title | Description |
|---|---|---|
| FG000 | Otezla Plus Enstilar Foam | Subjects randomized to this group will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily Enstilar: Enstilar foam applied to affected areas daily Otezla: Otezla 30mg |
| FG001 | Otezla Plus Vehicle Foam | Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily Vehicle: vehicle foam applied to affected areas once daily Otezla: Otezla 30mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Otezla Plus Enstilar Foam | Subjects in the study will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily Enstilar: Enstilar foam applied to affected areas daily Otezla: Otezla 30mg |
| BG001 | Otezla Plus Vehicle Foam |
| 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 | Percent of Subjects With a Psoriasis Assessment and Severity Index (PASI) 75 at Week 16 | PASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.) The body is divided into 4 sections: head (10% of total body surface area,) arms (20%,) trunk(30%,) and legs (40%.) Each of these is scored by itself and the 4 scores then combined to obtain thePASI. For each body area, the percent of skin area involved is estimated and graded based on this value (0=0% of area involved, 1=<10%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%.) Within each area, the severity of disease is based on 3 clinical signs: erythema or redness, induration or thickness, and desquamation or scaliness. Each is graded on a scale from 0(none) to 4(maximum.) The sum of all 3 parameters is calculated for each body section, multiplied by the area score for that section and then multiplied by the weight of that section (.1for head, .2 arms, .3 trunk and .4 legs) | Posted | Count of Participants | Participants | 16 weeks |
|
screening to week 16
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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 | Otezla Plus Enstilar Foam | Subjects in the study will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily Enstilar: Enstilar foam applied to affected areas daily Otezla: Otezla 30mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sinus tachycardia | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| increased joint pain generalized | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. McAllister | Skin Sciences, PLLC | 5024519000 | mmdermresearch@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2017 | Feb 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C517164 | betamethasone dipropionate, calcipotriol drug combination |
| C505730 | apremilast |
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| Vehicle | Drug | vehicle foam applied to affected areas once daily |
|
| Otezla | Drug | Otezla 30mg |
|
| Percent of Subjects With PASI 90 and 100 at Week 16 |
Psoriasis Area & Severity Index (PASI) is a tool used to measure the severity of psoriasis. It combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.) |
| 16 weeks |
| Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16 | The Investigator will rate the severity of of disease based on the assessment of 3 clinical signs (erythema, induration, desquamation) wherein 0=no signs of psoriasis, 1=almost clear, 2=mild, 3=moderate, 4=severe | 4 weeks, 12 weeks, 16 weeks |
| Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16 | The Itch VAS (Visual Analog Scale) is completed by subjects wherein they are asked to rate the severity of their itching over the last 48 hours on a scale from 0 (no itching) to 10 (unbearable itching); low scores indicate a better outcome. | 4 weeks, 12 weeks, 16 weeks |
| Global Percent Improvement in Dermatologic Quality of Life Index (DLQI) at Week 4, 12, and 16 | The DLQI is a 10-question tool completed by subjects to ascertain the severity of disease based on the extent to which disease interferes with daily life. Each question is scored according to the response wherein Very Much =3, A lot=2, A little=1 and Not at all=0. The sum of all responses is then recorded on a scale from 0 to 30, lower scores indicating better quality of life. | 4 weeks, 12, weeks, 16 weeks |
| Louisville |
| Kentucky |
| 40217 |
| United States |
| Lawrence J. Green, MD LLC | Rockville | Maryland | 20850 | United States |
| Dermatology & Laser Center of Charleston | Charleston | South Carolina | 29414 | United States |
| Protocol Violation |
|
| Lost to Follow-up |
|
Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily Vehicle: vehicle foam applied to affected areas once daily Otezla: Otezla 30mg |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Otezla Plus Enstilar Foam |
Subjects in the study will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily Enstilar: Enstilar foam applied to affected areas daily Otezla: Otezla 30mg |
| OG001 | Otezla Plus Vehicle Foam | Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily Vehicle: vehicle foam applied to affected areas once daily Otezla: Otezla 30mg |
|
|
| Secondary | Percent of Subjects With PASI 75 at Week 4 and Week 12 | Psoriasis Area & Severity Index (PASI) is a tool used to measure the severity of psoriasis. It combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.) | Posted | Count of Participants | Participants | 4 weeks, 12 weeks |
|
|
|
| Secondary | Percent of Subjects With PASI 90 and 100 at Week 16 | Psoriasis Area & Severity Index (PASI) is a tool used to measure the severity of psoriasis. It combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.) | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| Secondary | Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16 | The Investigator will rate the severity of of disease based on the assessment of 3 clinical signs (erythema, induration, desquamation) wherein 0=no signs of psoriasis, 1=almost clear, 2=mild, 3=moderate, 4=severe | Posted | Count of Participants | Participants | 4 weeks, 12 weeks, 16 weeks |
|
|
|
| Secondary | Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16 | The Itch VAS (Visual Analog Scale) is completed by subjects wherein they are asked to rate the severity of their itching over the last 48 hours on a scale from 0 (no itching) to 10 (unbearable itching); low scores indicate a better outcome. | Posted | Mean | Standard Deviation | scale unit | 4 weeks, 12 weeks, 16 weeks |
|
|
|
| Secondary | Global Percent Improvement in Dermatologic Quality of Life Index (DLQI) at Week 4, 12, and 16 | The DLQI is a 10-question tool completed by subjects to ascertain the severity of disease based on the extent to which disease interferes with daily life. Each question is scored according to the response wherein Very Much =3, A lot=2, A little=1 and Not at all=0. The sum of all responses is then recorded on a scale from 0 to 30, lower scores indicating better quality of life. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks, 12, weeks, 16 weeks |
|
|
|
| 0 |
| 14 |
| 1 |
| 14 |
| 5 |
| 14 |
| EG001 | Otezla Plus Vehicle Foam | Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily Vehicle: vehicle foam applied to affected areas once daily Otezla: Otezla 30mg | 0 | 14 | 0 | 14 | 9 | 14 |
| upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| chronic obstructive pulmonary disease exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| shortness of air | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| chest congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | right upper arm |
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| overactive bladder | Renal and urinary disorders | Systematic Assessment |
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| dyspnea at rest | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| fall at home | General disorders | Systematic Assessment |
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| hypertension | Cardiac disorders | Systematic Assessment |
|
| compressed lumbar disc | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| right flank pain | General disorders | Systematic Assessment |
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| nausea | General disorders | Systematic Assessment |
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| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| dry cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| right ankle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| intertrigo | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| right lower jaw pain | General disorders | Systematic Assessment |
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| root canal | Surgical and medical procedures | Systematic Assessment |
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| bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| frequent muscle fasciculation right lower eyelid | General disorders | Systematic Assessment |
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| sensation of fullness in neck | General disorders | Systematic Assessment |
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| persistent lower extremity edema | Cardiac disorders | Systematic Assessment |
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| abrasion right shin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| headache | General disorders | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| abdominal cramping | Gastrointestinal disorders | Systematic Assessment |
|
| generalized rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| mild |
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| moderate |
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| severe |
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| week 12 |
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| week 16 |
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| week 16 |
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| week 16 |
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