CompletedNCT02412644Updated Jan 28, 2019Results posted

Apremilast 30mg Bid With Narrowband UVB in the Treatment of Plaque Psoriasis

A Phase 4 interventional study of apremilast in Plaque Psoriasis, sponsored by Psoriasis Treatment Center of Central New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-28.

Sponsored by Psoriasis Treatment Center of Central New Jersey · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 29
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

12 weeks open label with Otezla® and NUVB, followed by 6 month double blind Otezla® (apremilast) or placebo to subjects who obtain PASI 75 at week 12 of phototherapy

Read the detailed description

Primary Objective: To evaluate the effectiveness of Otezla (apremilast®) in promoting maintenance of response in those subjects who obtained PASI-75 at week 12 of phototherapy.

Conditions studied

Plaque Psoriasis

Browse trials for

Psoriasis 1,899

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 29 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Psoriasis Treatment Center of Central New Jersey is the lead sponsor of 17 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria: Subjects must meet the following criteria to be enrolled in this study:

Male or female adult ≥ 18 years of age;
Diagnosis of chronic plaque-type
Moderate to severe plaque type psoriasis as defined at baseline by:
- PASI score of 12 or greater,
- PGA score of 3 or greater
- BSA affected by plaque-type psoriasis of 10% or greater,
Able and willing to give written informed consent prior to performance of any study-related procedures

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from participation in this study:

Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis
Subjects with previous exposure to apremilast
Malignancy or history of malignancy, except for:
- treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
- treated [ie, cured] malignancy with no evidence of recurrence within the previous 5 years.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 29 participants (actual)

Study arms

Active comparator
Apremilast + apremilast
apremilast 30mg bid for 12 weeks.followed by apremilast 30 mg bid for 24 weeks
Drug: apremilast
Placebo comparator
apremilast + placebo
apremilast 30mg bid for 12 weeks followed by placebo bid for 24 weeks
Drug: apremilast

Interventions

Drugapremilast

What researchers measure

Primary outcomes

Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36
Analysis of Psoriasis Area Severity Index Score at week 36 to determine number of subjects who maintained PASI 75 at week 36
Time frame: 36weeks

Secondary outcomes

Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12
Psoriasis Area Severity Score of 75 or greater at week 12
Time frame: 12WEEKS
Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36
PASI 90 or greater at week 36
Time frame: 36 weeks
Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36
PGA score 0 or 1
Time frame: 36 weeks

Results

Posted Jan 28, 2019

Participant flow

Recruitment May 28 2015-November 2015 through practice database

Participant flow — Overall Study
Milestone	Apremilast + Apremilast	Apremilast + Placebo
Started	21	8
Completed	6	4
Not completed	15	4

Outcome measures

PrimaryNumber of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36

Analysis of Psoriasis Area Severity Index Score at week 36 to determine number of subjects who maintained PASI 75 at week 36

Time frame:: 36weeks
Reported as:: Number · participants

Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36
participants	Apremilast + Apremilast	Apremilast + Placebo
Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36	4	2

SecondaryNumber of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12

Psoriasis Area Severity Score of 75 or greater at week 12

Time frame:: 12WEEKS
Reported as:: Number · participants

Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12
participants	Apremilast
Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12	16

SecondaryNumber of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36

PASI 90 or greater at week 36

Time frame:: 36 weeks
Reported as:: Number · participants

Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36
participants	Apremilast + Apremilast	Apremilast + Placebo
Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36	1	0

SecondaryNumber of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36

PGA score 0 or 1

Time frame:: 36 weeks
Reported as:: Number · participants

Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36
participants	Apremilast + Apremilast	Apremilast + Placebo
Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36	1	0

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Apremilast 30mg BID First 12 Weeks	0/29 (0%)	1/29 (3.4%)	13/29 (44.8%)
Apremilast 30mg BID After 12 Weeks	0/8 (0%)	0/8 (0%)	3/8 (37.5%)
Placebo BID After 12 Weeks	0/8 (0%)	1/8 (12.5%)	5/8 (62.5%)

Most frequent serious events

Most frequent serious events
Event	Apremilast 30mg BID First 12 Weeks	Apremilast 30mg BID After 12 Weeks	Placebo BID After 12 Weeks
Arterial rupture right legVascular disorders	0/29	0/8	1/8
second degree burnSkin and subcutaneous tissue disorders	1/29	0/8	0/8

Most frequent other events

Most frequent other events
Event	Apremilast 30mg BID First 12 Weeks	Apremilast 30mg BID After 12 Weeks	Placebo BID After 12 Weeks
First degree burnSkin and subcutaneous tissue disorders	11/29	0/8	0/8
worsening of psoriasisSkin and subcutaneous tissue disorders	1/29	1/8	3/8
abdominal painGastrointestinal disorders	0/29	2/8	1/8
bronchitisRespiratory, thoracic and mediastinal disorders	1/29	0/8	1/8

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Apremilast + Apremilast	Apremilast + Placebo	Total
Mean	44 ± 22	55 ± 38	47 ± 50

Sex: Female, Male
Sex: Female, Male(Participants)	Apremilast + Apremilast	Apremilast + Placebo	Total
Female	9	3	12
Male	12	5	17

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Apremilast + Apremilast	Apremilast + Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	3	0	3
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	15	6	21
More than one race	0	1	1
Unknown or Not Reported	3	1	4

Region of Enrollment
Region of Enrollment(participants)	Apremilast + Apremilast	Apremilast + Placebo	Total
United States	21	8	29

Study locations

1 site

Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey 08520, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02412644
Lead sponsor: Psoriasis Treatment Center of Central New Jersey
Collaborators: Celgene
Responsible party: Sponsor
First posted: Apr 9, 2015
Start date: May 28, 2015
Primary completion: Jul 2016
Completion: Jul 2016
Results posted: Jan 28, 2019
Last update: Jan 28, 2019

Study contacts

Jerry Bagel, MD

principal investigator · Psoriasis Treatment Center of Central New Jersey

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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