Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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

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 ]

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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