Safety and Efficacy Study of CF101 to Treat 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
CF101 1 mg Twice Daily (BID)	Oral tablets given every 12 hours for 12 weeks
CF101 2 mg BID	Oral tablets given every 12 hours for 12 weeks
CF101 4 mg BID	Oral tablets given every 12 hours for 12 weeks
Placebo	Oral tablets given every 12 hours for 12 weeks

Participant Flow:   Overall Study

	CF101 1 mg Twice Daily (BID)	CF101 2 mg BID	CF101 4 mg BID	Placebo
STARTED	25 [1]	17	15	19
COMPLETED	17	17	14	16
NOT COMPLETED	8	0	1	3

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.
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Reporting Groups

	Description
CF101 1 mg Twice Daily (BID)	Oral tablets given every 12 hours for 12 weeks
CF101 2 mg BID	Oral tablets given every 12 hours for 12 weeks
CF101 4 mg BID	Oral tablets given every 12 hours for 12 weeks
Placebo	Oral tablets given every 12 hours for 12 weeks
Total	Total of all reporting groups

Baseline Measures

	CF101 1 mg Twice Daily (BID)	CF101 2 mg BID	CF101 4 mg BID	Placebo	Total
Overall Participants Analyzed  [Units: Participants]	24	17	15	19	75
Age  [Units: Participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	19	16	14	17	66
>=65 years	5	1	1	2	9
Age  [Units: Years] Mean (Standard Deviation)	51.5  (12.0)	48.4  (10.2)	45.3  (12.1)	51.2  (10.4)	49.5  (11.2)
Gender  [Units: Participants]
Female	5	2	5	5	17
Male	19	15	10	14	58
Region of Enrollment  [Units: Participants]
Israel	24	17	15	19	75

1.  Primary:

Change From Baseline (CFB) in Psoriasis Area and Severity Index (PASI) Score   [ Time Frame: 12 weeks minus baseline ]

2.  Secondary:

The Number of Patients Who Achieve a Score of "Almost Clear" or "Clear" by Physician's Global Assessment (PGA)   [ Time Frame: 12 weeks ]

3.  Primary:

Frequency and Nature of Adverse Events   [ Time Frame: 12 weeks ]

4.  Secondary:

Individual PASI Components Redness, Thickness, and Scale   [ Time Frame: 12 weeks ]

5.  Secondary:

Relationship Between Peripheral Blood Mononuclear Cell Adenosine A3 Receptor (A3AR) Expression Level at Baseline and Response to Therapy.   [ Time Frame: 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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