Trial Outcomes & Findings for Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis (NCT NCT03441789)
NCT ID: NCT03441789
Last Updated: 2019-03-14
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
28 participants
Primary outcome timeframe
16 weeks
Results posted on
2019-03-14
Participant Flow
1 participant signed consent but failed screening
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Otezla Plus Enstilar Foam
n=14 Participants
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
|
Otezla Plus Vehicle Foam
n=14 Participants
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
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 17 • n=5 Participants
|
52 years
STANDARD_DEVIATION 12 • n=7 Participants
|
53 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPASI 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)
Outcome measures
| Measure |
Otezla Plus Enstilar Foam
n=14 Participants
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
|
Otezla Plus Vehicle Foam
n=14 Participants
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
|
|---|---|---|
|
Percent of Subjects With a Psoriasis Assessment and Severity Index (PASI) 75 at Week 16
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 4 weeks, 12 weeksPsoriasis 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.)
Outcome measures
| Measure |
Otezla Plus Enstilar Foam
n=14 Participants
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
|
Otezla Plus Vehicle Foam
n=14 Participants
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
|
|---|---|---|
|
Percent of Subjects With PASI 75 at Week 4 and Week 12
week 4
|
7 Participants
|
1 Participants
|
|
Percent of Subjects With PASI 75 at Week 4 and Week 12
week 12
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPsoriasis 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.)
Outcome measures
| Measure |
Otezla Plus Enstilar Foam
n=14 Participants
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
|
Otezla Plus Vehicle Foam
n=14 Participants
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
|
|---|---|---|
|
Percent of Subjects With PASI 90 and 100 at Week 16
PASI 90
|
4 Participants
|
2 Participants
|
|
Percent of Subjects With PASI 90 and 100 at Week 16
PASI 100
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeks, 12 weeks, 16 weeksThe 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
Outcome measures
| Measure |
Otezla Plus Enstilar Foam
n=14 Participants
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
|
Otezla Plus Vehicle Foam
n=14 Participants
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
|
|---|---|---|
|
Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
week 4 · clear
|
1 Participants
|
0 Participants
|
|
Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
week 4 · almost clear
|
5 Participants
|
1 Participants
|
|
Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
week 4 · mild
|
7 Participants
|
4 Participants
|
|
Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
week 4 · moderate
|
1 Participants
|
9 Participants
|
|
Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
week 4 · severe
|
0 Participants
|
0 Participants
|
|
Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
week 12 · clear
|
1 Participants
|
0 Participants
|
|
Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
week 12 · almost clear
|
1 Participants
|
3 Participants
|
|
Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
week 12 · mild
|
5 Participants
|
4 Participants
|
|
Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
week 12 · moderate
|
6 Participants
|
7 Participants
|
|
Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
week 12 · severe
|
1 Participants
|
0 Participants
|
|
Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
week 16 · clear
|
1 Participants
|
1 Participants
|
|
Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
week 16 · almost clear
|
8 Participants
|
1 Participants
|
|
Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
week 16 · mild
|
4 Participants
|
3 Participants
|
|
Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
week 16 · moderate
|
0 Participants
|
9 Participants
|
|
Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
week 16 · severe
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeks, 12 weeks, 16 weeksThe 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.
Outcome measures
| Measure |
Otezla Plus Enstilar Foam
n=14 Participants
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
|
Otezla Plus Vehicle Foam
n=14 Participants
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
|
|---|---|---|
|
Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16
week 4
|
2 scale unit
Standard Deviation 2
|
5 scale unit
Standard Deviation 3
|
|
Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16
week 12
|
4 scale unit
Standard Deviation 3
|
4 scale unit
Standard Deviation 3
|
|
Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16
week 16
|
3 scale unit
Standard Deviation 3
|
4 scale unit
Standard Deviation 3
|
SECONDARY outcome
Timeframe: 4 weeks, 12, weeks, 16 weeksThe 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.
Outcome measures
| Measure |
Otezla Plus Enstilar Foam
n=14 Participants
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
|
Otezla Plus Vehicle Foam
n=14 Participants
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
|
|---|---|---|
|
Global Percent Improvement in Dermatologic Quality of Life Index (DLQI) at Week 4, 12, and 16
week 4
|
2 score on a scale
Standard Deviation 2
|
5 score on a scale
Standard Deviation 4
|
|
Global Percent Improvement in Dermatologic Quality of Life Index (DLQI) at Week 4, 12, and 16
week 12
|
5 score on a scale
Standard Deviation 5
|
5 score on a scale
Standard Deviation 4
|
|
Global Percent Improvement in Dermatologic Quality of Life Index (DLQI) at Week 4, 12, and 16
week 16
|
3 score on a scale
Standard Deviation 4
|
6 score on a scale
Standard Deviation 6
|
Adverse Events
Otezla Plus Enstilar Foam
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Otezla Plus Vehicle Foam
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Otezla Plus Enstilar Foam
n=14 participants at risk
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
|
Otezla Plus Vehicle Foam
n=14 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
sinus tachycardia
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
0.00%
0/14 • screening to week 16
|
|
Infections and infestations
upper respiratory infection
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
0.00%
0/14 • screening to week 16
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease exacerbation
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
0.00%
0/14 • screening to week 16
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
0.00%
0/14 • screening to week 16
|
|
Respiratory, thoracic and mediastinal disorders
shortness of air
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
0.00%
0/14 • screening to week 16
|
Other adverse events
| Measure |
Otezla Plus Enstilar Foam
n=14 participants at risk
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
|
Otezla Plus Vehicle Foam
n=14 participants at risk
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
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
increased joint pain generalized
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhea
|
14.3%
2/14 • Number of events 2 • screening to week 16
|
0.00%
0/14 • screening to week 16
|
|
Respiratory, thoracic and mediastinal disorders
chest congestion
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
0.00%
0/14 • screening to week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
squamous cell carcinoma
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
0.00%
0/14 • screening to week 16
|
|
Renal and urinary disorders
overactive bladder
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
0.00%
0/14 • screening to week 16
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea at rest
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
0.00%
0/14 • screening to week 16
|
|
General disorders
fall at home
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
0.00%
0/14 • screening to week 16
|
|
Cardiac disorders
hypertension
|
0.00%
0/14 • screening to week 16
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
|
Musculoskeletal and connective tissue disorders
compressed lumbar disc
|
0.00%
0/14 • screening to week 16
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
|
General disorders
right flank pain
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
0.00%
0/14 • screening to week 16
|
|
General disorders
nausea
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
14.3%
2/14 • Number of events 2 • screening to week 16
|
|
Respiratory, thoracic and mediastinal disorders
dry cough
|
0.00%
0/14 • screening to week 16
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
|
Musculoskeletal and connective tissue disorders
right ankle pain
|
0.00%
0/14 • screening to week 16
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
|
Skin and subcutaneous tissue disorders
intertrigo
|
0.00%
0/14 • screening to week 16
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
|
General disorders
right lower jaw pain
|
0.00%
0/14 • screening to week 16
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
|
Surgical and medical procedures
root canal
|
0.00%
0/14 • screening to week 16
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
0.00%
0/14 • screening to week 16
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
|
General disorders
frequent muscle fasciculation right lower eyelid
|
0.00%
0/14 • screening to week 16
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
|
General disorders
sensation of fullness in neck
|
0.00%
0/14 • screening to week 16
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
|
Cardiac disorders
persistent lower extremity edema
|
0.00%
0/14 • screening to week 16
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
|
Skin and subcutaneous tissue disorders
abrasion right shin
|
0.00%
0/14 • screening to week 16
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
|
General disorders
headache
|
0.00%
0/14 • screening to week 16
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
|
Gastrointestinal disorders
diarrhea
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
0.00%
0/14 • screening to week 16
|
|
Gastrointestinal disorders
abdominal cramping
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
0.00%
0/14 • screening to week 16
|
|
Skin and subcutaneous tissue disorders
generalized rash
|
0.00%
0/14 • screening to week 16
|
7.1%
1/14 • Number of events 1 • screening to week 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place