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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01690299
First received: September 19, 2012
Last updated: August 21, 2015
Last verified: August 2015
Results First Received: July 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Psoriasis
Psoriatic Arthritis
Interventions: Drug: Apremilast tablet/pill 30 mg
Drug: Etanercept 50 mg
Drug: Placebo tablet
Drug: Placebo injection (saline)

  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
This is an ongoing study consisting of a 16-week randomized, double-blind, double-dummy, placebo-controlled phase, an 88-week extension phase and a 4-week post treatment observational follow-up phase for an overall study duration of 2 years. This report includes data up to the end of the 16-week double-blind, double-dummy,placebo-controlled phase.

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

Reporting Groups
  Description
Placebo Placebo tablets orally (PO), twice a day (BID) and 2-1 milliliter (ml) placebo subcutaneous (SC) saline injections once weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
Apremilast 30mg Plus Placebo Injection 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 50mg Plus Placebo Tablet Etanercept 50 mg by SC injection QW plus placebo tablets PO, BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase

Participant Flow:   Overall Study
    Placebo     Apremilast 30mg Plus Placebo Injection     Etanercept 50mg Plus Placebo Tablet  
STARTED     84     83     83  
COMPLETED     75     77     81  
NOT COMPLETED     9     6     2  
Adverse Event                 2                 2                 1  
Lack of Efficacy                 4                 0                 0  
Withdrawal by Subject                 1                 3                 0  
Unspecified                 2                 1                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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 Placebo tablets orally (PO), twice a day (BID) and 2-1 milliliter (ml) Placebo subcutaneous (SC) saline injections once weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
Apremilast 30mg Plus Placebo Injection Apremilast 30 mg PO BID plus 2-1ml Placebo SC saline injections once QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
Etanercept 50mg Plus Placebo Tablet 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 30mg Plus Placebo Injection     Etanercept 50mg Plus Placebo Tablet     Total  
Number of Participants  
[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)  
Gender  
[units: participants]
       
Female     25     34     34     93  
Male     59     49     49     157  



  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:   Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo Controlled Phase   [ Time Frame: First dose of study drug to the end of the placebo controlled phase ]

3.  Secondary:   Psoriasis Flare/Rebound   [ Time Frame: First dose of study drug to the end of the placebo controlled phase ]

4.  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 From Baseline   [ Time Frame: Baseline and Week 16 ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

5.  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 ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

6.  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 ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

7.  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: From Baseline to Week 16 ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

8.  Secondary:   Change From Baseline in Dermatology Life Quality Index (DLQI) In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16   [ Time Frame: Baseline to Week 16 ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

9.  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 and Week 16 ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

10.  Secondary:   Percentage of Participants With 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 ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No


  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
No text entered.


  More Information
  Hide More Information

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


No publications provided


Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01690299     History of Changes
Other Study ID Numbers: CC-10004-PSOR-010, 2012-000859-14
Study First Received: September 19, 2012
Results First Received: July 2, 2015
Last Updated: August 21, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency