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

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ClinicalTrials.gov Identifier: NCT02412644
Recruitment Status : Completed
First Posted : April 9, 2015
Results First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Psoriasis Treatment Center of Central New Jersey

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Intervention Drug: apremilast
Enrollment 29
Recruitment Details Recruitment May 28 2015-November 2015 through practice database
Pre-assignment Details  
Arm/Group Title Apremilast + Apremilast Apremilast + Placebo
Hide Arm/Group Description apremilast 30 mg BID for 12 weeks + apremilast 30 mg BID through week 36 apremilast 30 mg BID for 12 weeks + placebo BID through week 36
Period Title: Overall Study
Started 21 8
Completed 6 4
Not Completed 15 4
Arm/Group Title Apremilast + Apremilast Apremilast + Placebo Total
Hide Arm/Group Description apremilast + apremilast 30mg bid after week 12 apremilast + Placebo bid after week 12 Total of all reporting groups
Overall Number of Baseline Participants 21 8 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 8 participants 29 participants
44  (22) 55  (38) 47  (50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 8 participants 29 participants
Female
9
  42.9%
3
  37.5%
12
  41.4%
Male
12
  57.1%
5
  62.5%
17
  58.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 8 participants 29 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
  14.3%
0
   0.0%
3
  10.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
15
  71.4%
6
  75.0%
21
  72.4%
More than one race
0
   0.0%
1
  12.5%
1
   3.4%
Unknown or Not Reported
3
  14.3%
1
  12.5%
4
  13.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 8 participants 29 participants
21 8 29
1.Primary Outcome
Title Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast + Apremilast Apremilast + Placebo
Hide Arm/Group Description:
apremilast + apremilast
apremilast + placebo
Overall Number of Participants Analyzed 6 4
Measure Type: Number
Unit of Measure: participants
4 2
2.Secondary Outcome
Title Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12
Hide Description Psoriasis Area Severity Score of 75 or greater at week 12
Time Frame 12WEEKS
Hide Outcome Measure Data
Hide Analysis Population Description
22 subjects completed week 12
Arm/Group Title Apremilast
Hide Arm/Group Description:
apremilast
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants
16
3.Secondary Outcome
Title Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36
Hide Description PASI 90 or greater at week 36
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast + Apremilast Apremilast + Placebo
Hide Arm/Group Description:
apremilast 30 mg BID for 12 weeks + apremilast 30 mg BID through week 36
apremilast 30 mg BID for 12 weeks + placebo BID through week 36
Overall Number of Participants Analyzed 6 4
Measure Type: Number
Unit of Measure: participants
1 0
4.Secondary Outcome
Title Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36
Hide Description PGA score 0 or 1
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast + Apremilast Apremilast + Placebo
Hide Arm/Group Description:
apremilast 30 mg BID for 12 weeks + apremilast 30 mg BID through week 36
apremilast 30 mg BID for 12 weeks + placebo BID through week 36
Overall Number of Participants Analyzed 6 4
Measure Type: Number
Unit of Measure: participants
1 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Apremilast 30mg BID First 12 Weeks Apremilast 30mg BID After 12 Weeks Placebo BID After 12 Weeks
Hide Arm/Group Description apremilast 30mg bid for 12 weeks apremilast bid after week 12 placebo bid after week 12
All-Cause Mortality
Apremilast 30mg BID First 12 Weeks Apremilast 30mg BID After 12 Weeks Placebo BID After 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)      0/8 (0.00%)      0/8 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Apremilast 30mg BID First 12 Weeks Apremilast 30mg BID After 12 Weeks Placebo BID After 12 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/29 (3.45%)      0/8 (0.00%)      1/8 (12.50%)    
Skin and subcutaneous tissue disorders       
second degree burn [1]  1/29 (3.45%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Vascular disorders       
Arterial rupture right leg [2]  0/29 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
[1]
burn related NBUVB
[2]
arterial rupture during catheterization
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Apremilast 30mg BID First 12 Weeks Apremilast 30mg BID After 12 Weeks Placebo BID After 12 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/29 (44.83%)      3/8 (37.50%)      5/8 (62.50%)    
Gastrointestinal disorders       
abdominal pain  0/29 (0.00%)  0 2/8 (25.00%)  2 1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders       
bronchitis  1/29 (3.45%)  2 0/8 (0.00%)  0 1/8 (12.50%)  1
Skin and subcutaneous tissue disorders       
worsening of psoriasis  1/29 (3.45%)  1 1/8 (12.50%)  1 3/8 (37.50%)  3
First degree burn  11/29 (37.93%)  19 0/8 (0.00%)  0 0/8 (0.00%)  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jerry Bagel Director of Clinical Trials
Organization: Psoriasis Treatment Center of Central New Jersey
Phone: 6094434500
EMail: dreamacres1@aol.com
Layout table for additonal information
Responsible Party: Psoriasis Treatment Center of Central New Jersey
ClinicalTrials.gov Identifier: NCT02412644     History of Changes
Other Study ID Numbers: AP-CL-PSOR-PI-004893
First Submitted: February 23, 2015
First Posted: April 9, 2015
Results First Submitted: March 2, 2017
Results First Posted: January 28, 2019
Last Update Posted: January 28, 2019