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Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene
ClinicalTrials.gov Identifier:
NCT01690299
First received: September 19, 2012
Last updated: May 12, 2017
Last verified: May 2017
Results First Received: July 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Psoriasis
Psoriatic Arthritis
Interventions: Drug: Apremilast
Drug: Etanercept
Drug: Placebo tablet
Drug: Placebo injection

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 65 study centers in 11 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomized 1:1:1 to the three treatment groups. Participants were stratified according to their calculated body mass index (BMI) categories at Screening (BMI < 30 or BMI ≥ 30).

Reporting Groups
  Description
Placebo Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
Apremilast Plus Placebo Injection Participants received apremilast 30 mg PO BID plus 2-1ml placebo SC saline injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
Etanercept Plus Placebo Tablet Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
Placebo/Apremilast Participants received identically matching placebo tablets by PO, BID and SC saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg apremilast PO BID and remained on this dose through week 104.
Apremilast/Apremilast Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID only through week 104.
Etanercept/Apremilast Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants discontinued etanercept and were switched to apremilast 30mg PO BID through week 104.

Participant Flow for 2 periods

Period 1:   Placebo-controlled Phase (Weeks 0-16)
    Placebo   Apremilast Plus Placebo Injection   Etanercept Plus Placebo Tablet   Placebo/Apremilast   Apremilast/Apremilast   Etanercept/Apremilast
STARTED   84   83   83   0   0   0 
Safety Population   84 [1]   83 [1]   83 [1]   0   0   0 
COMPLETED   75   77   81   0   0   0 
NOT COMPLETED   9   6   2   0   0   0 
Adverse Event                2                2                1                0                0                0 
Lack of Efficacy                4                0                0                0                0                0 
Withdrawal by Subject                1                3                0                0                0                0 
Unspecified                2                1                1                0                0                0 
[1] Safety population includes all participants who received at least one dose of study drug.

Period 2:   Apremilast Extension Phase (Weeks16-104)
    Placebo   Apremilast Plus Placebo Injection   Etanercept Plus Placebo Tablet   Placebo/Apremilast   Apremilast/Apremilast   Etanercept/Apremilast
STARTED   0   0   0   73 [1]   74 [1]   80 [1] 
Safety Population   0   0   0   73 [2]   74 [2]   79 [2] 
COMPLETED   0   0   0   47   41   50 
NOT COMPLETED   0   0   0   26   33   30 
Adverse Event                0                0                0                3                4                3 
Lack of Efficacy                0                0                0                9                10                8 
Non-compliance With Study Drug                0                0                0                0                1                1 
Withdrawal by Subject                0                0                0                8                5                11 
Lost to Follow-up                0                0                0                6                13                6 
Protocol Violation                0                0                0                0                0                1 
[1] There are fewer participants in this period because some stopped the study at or prior to Week 16.
[2] Safety population includes all participants who received at least one dose of study drug.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized population includes all randomized participants.

Reporting Groups
  Description
Placebo Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
Apremilast Plus Placebo Injection Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
Etanercept Plus Placebo Tablet Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
Total Total of all reporting groups

Baseline Measures
   Placebo   Apremilast Plus Placebo Injection   Etanercept Plus Placebo Tablet   Total 
Overall Participants Analyzed 
[Units: Participants]
 84   83   83   250 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.4  (14.91)   46.0  (13.59)   47.0  (14.07)   45.4  (14.23) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      25  29.8%      34  41.0%      34  41.0%      93  37.2% 
Male      59  70.2%      49  59.0%      49  59.0%      157  62.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline   [ Time Frame: Baseline to Week 16 ]

2.  Secondary:   Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI) for the Comparison Between Etanercept 50mg SC QW and Placebo at Week 16   [ Time Frame: Baseline and Week 16 ]

3.  Secondary:   Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16   [ Time Frame: Baseline and Week 16 ]

4.  Secondary:   Percent Change From Baseline in the Affected Body Surface Area (BSA) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16   [ Time Frame: Baseline to Week 16 ]

5.  Secondary:   Percentage of Participants Who Achieved a 50% Improvement (Response) in the Psoriasis Area Severity Index (PASI-50) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16   [ Time Frame: Baseline to Week 16 ]

6.  Secondary:   Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16   [ Time Frame: Baseline to Week 16 ]

7.  Secondary:   Change From Baseline in the Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16   [ Time Frame: Baseline to Week 16 ]

8.  Secondary:   Percentage of Participants Who Achieved a Lattice System Physician’s Global Assessment (LS-PGA) Score of Clear (0) or Almost Clear at Week 16 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16   [ Time Frame: Baseline to Week 16 ]

9.  Secondary:   Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase   [ Time Frame: Week 0 to Week 16; mean duration of exposure was 14.90 weeks for placebo group, 15.13 weeks for apremilast group and 15.87 weeks for Etanercept group ]

10.  Secondary:   Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period   [ Time Frame: From the first dose of apremilast (either Week 0 for participants originally randomized to apremilast or Week 16 for those originally randomized to placebo or etanercept who were switched to apremilast at week 16) until 28 days after last apremilast dose ]

11.  Secondary:   Psoriasis Flare/Rebound   [ Time Frame: Week 0 to Week 16; Placebo controlled phase ]

12.  Secondary:   Psoriasis Flare/Rebound   [ Time Frame: From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo or etanercept who were switched at Week 16) until 28 days after the last dose of apremilast. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
Organization: Celgene Corporation
phone: 888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com



Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01690299     History of Changes
Other Study ID Numbers: CC-10004-PSOR-010
2012-000859-14 ( EudraCT Number )
Study First Received: September 19, 2012
Results First Received: July 2, 2015
Last Updated: May 12, 2017