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Trial record 1 of 1 for:    Apo805K1
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Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT01483924
Recruitment Status : Completed
First Posted : December 2, 2011
Results First Posted : February 20, 2015
Last Update Posted : February 20, 2015
Sponsor:
Information provided by (Responsible Party):
ApoPharma

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: Apo805K1

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
Apo805K1 10 mg Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
Apo805K1 30 mg Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
Apo805K1 60 mg Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
Apo805K1 100 mg Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks

Participant Flow:   Overall Study
    Placebo   Apo805K1 10 mg   Apo805K1 30 mg   Apo805K1 60 mg   Apo805K1 100 mg
STARTED   12   12   12   12   12 
COMPLETED   10   12   11   8   10 
NOT COMPLETED   2   0   1   4   2 
Withdrawal by Subject                2                0                0                1                1 
Adverse Event                0                0                1                1                0 
Non-compliance                0                0                0                1                1 
Sponsor concern over ECG result                0                0                0                1                0 



  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.
A total of 60 patients were enrolled. No formal sample size calculation for this study was done, as this study was an exploratory study with main objective to assess the safety and tolerability of Apo805K1.

Reporting Groups
  Description
Placebo Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
Apo805K1 10 mg Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
Apo805K1 30 mg Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
Apo805K1 60 mg Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
Apo805K1 100 mg Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Total Total of all reporting groups

Baseline Measures
   Placebo   Apo805K1 10 mg   Apo805K1 30 mg   Apo805K1 60 mg   Apo805K1 100 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   12   12   12   60 
Age 
[Units: Participants]
           
<=18 years   0   0   0   0   0   0 
Between 18 and 65 years   12   12   12   12   12   60 
>=65 years   0   0   0   0   0   0 
Gender 
[Units: Participants]
           
Female   3   5   8   3   0   19 
Male   9   7   4   9   12   41 
Race (NIH/OMB) 
[Units: Participants]
           
American Indian or Alaska Native   0   0   0   0   0   0 
Asian   1   0   2   1   0   4 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0   0 
Black or African American   2   4   0   1   3   10 
White   9   8   10   10   9   46 
More than one race   0   0   0   0   0   0 
Unknown or Not Reported   0   0   0   0   0   0 
Region of Enrollment 
[Units: Participants]
           
United States   11   12   12   9   7   51 
Canada   1   0   0   3   5   9 


  Outcome Measures

1.  Primary:   Number of Patients With Adverse Events   [ Time Frame: 12 Weeks ]

2.  Secondary:   Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14   [ Time Frame: 12 hours ]

3.  Secondary:   Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14   [ Time Frame: 12 hours ]

4.  Secondary:   AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14   [ Time Frame: 12 hours ]

5.  Secondary:   T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14   [ Time Frame: 12 hours ]

6.  Secondary:   Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores   [ Time Frame: Baseline to 12 Weeks ]

7.  Secondary:   Efficacy of APO805K1 as Assessed by Achievement of PASI-75   [ Time Frame: 12 weeks ]

8.  Secondary:   Efficacy of Apo805K1 as Assessed by Change From Baseline at Week 12 in Lattice System–Physician Global Assessment (LS-PGA) Scores   [ Time Frame: Baseline to 12 weeks ]

9.  Secondary:   Efficacy of Apo805K1 as Assessed by Change From Baseline to Week 12 in Physician Global Assessment (PGA) Score   [ Time Frame: Baseline to 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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

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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Fernando Tricta, MD
Organization: ApoPharma Inc.
phone: Phone: 416-401-7332
e-mail: ftricta@apopharma.com



Responsible Party: ApoPharma
ClinicalTrials.gov Identifier: NCT01483924     History of Changes
Other Study ID Numbers: AP03-0210
First Submitted: November 30, 2011
First Posted: December 2, 2011
Results First Submitted: January 20, 2015
Results First Posted: February 20, 2015
Last Update Posted: February 20, 2015