Trial Outcomes & Findings for Apremilast 30mg Bid With Narrowband UVB in the Treatment of Plaque Psoriasis (NCT NCT02412644)
NCT ID: NCT02412644
Last Updated: 2019-01-28
Results Overview
Analysis of Psoriasis Area Severity Index Score at week 36 to determine number of subjects who maintained PASI 75 at week 36
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
29 participants
Primary outcome timeframe
36weeks
Results posted on
2019-01-28
Participant Flow
Recruitment May 28 2015-November 2015 through practice database
Participant milestones
| Measure |
Apremilast + Apremilast
apremilast 30 mg BID for 12 weeks + apremilast 30 mg BID through week 36
|
Apremilast + Placebo
apremilast 30 mg BID for 12 weeks + placebo BID through week 36
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
8
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
15
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Apremilast 30mg Bid With Narrowband UVB in the Treatment of Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Apremilast + Apremilast
n=21 Participants
apremilast + apremilast 30mg bid after week 12
|
Apremilast + Placebo
n=8 Participants
apremilast + Placebo bid after week 12
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 22 • n=93 Participants
|
55 years
STANDARD_DEVIATION 38 • n=4 Participants
|
47 years
STANDARD_DEVIATION 50 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=93 Participants
|
8 participants
n=4 Participants
|
29 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 36weeksAnalysis of Psoriasis Area Severity Index Score at week 36 to determine number of subjects who maintained PASI 75 at week 36
Outcome measures
| Measure |
Apremilast + Apremilast
n=6 Participants
apremilast + apremilast
|
Apremilast + Placebo
n=4 Participants
apremilast + placebo
|
|---|---|---|
|
Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 12WEEKSPopulation: 22 subjects completed week 12
Psoriasis Area Severity Score of 75 or greater at week 12
Outcome measures
| Measure |
Apremilast + Apremilast
n=22 Participants
apremilast + apremilast
|
Apremilast + Placebo
apremilast + placebo
|
|---|---|---|
|
Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12
|
16 participants
|
—
|
SECONDARY outcome
Timeframe: 36 weeksPASI 90 or greater at week 36
Outcome measures
| Measure |
Apremilast + Apremilast
n=6 Participants
apremilast + apremilast
|
Apremilast + Placebo
n=4 Participants
apremilast + placebo
|
|---|---|---|
|
Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 36 weeksPGA score 0 or 1
Outcome measures
| Measure |
Apremilast + Apremilast
n=6 Participants
apremilast + apremilast
|
Apremilast + Placebo
n=4 Participants
apremilast + placebo
|
|---|---|---|
|
Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36
|
1 participants
|
0 participants
|
Adverse Events
Apremilast 30mg BID First 12 Weeks
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Apremilast 30mg BID After 12 Weeks
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo BID After 12 Weeks
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Apremilast 30mg BID First 12 Weeks
n=29 participants at risk
apremilast 30mg bid for 12 weeks
|
Apremilast 30mg BID After 12 Weeks
n=8 participants at risk
apremilast bid after week 12
|
Placebo BID After 12 Weeks
n=8 participants at risk
placebo bid after week 12
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
second degree burn
|
3.4%
1/29 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Vascular disorders
Arterial rupture right leg
|
0.00%
0/29
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
Other adverse events
| Measure |
Apremilast 30mg BID First 12 Weeks
n=29 participants at risk
apremilast 30mg bid for 12 weeks
|
Apremilast 30mg BID After 12 Weeks
n=8 participants at risk
apremilast bid after week 12
|
Placebo BID After 12 Weeks
n=8 participants at risk
placebo bid after week 12
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
worsening of psoriasis
|
3.4%
1/29 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
37.5%
3/8 • Number of events 3
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/29
|
25.0%
2/8 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
3.4%
1/29 • Number of events 2
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
First degree burn
|
37.9%
11/29 • Number of events 19
|
0.00%
0/8
|
0.00%
0/8
|
Additional Information
Jerry Bagel Director of Clinical Trials
Psoriasis Treatment Center of Central New Jersey
Phone: 6094434500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place