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Safety and Efficacy Study of CF101 to Treat Psoriasis

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ClinicalTrials.gov Identifier: NCT00428974
Recruitment Status : Completed
First Posted : January 30, 2007
Results First Posted : September 26, 2011
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Can-Fite BioPharma

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
Interventions Drug: CF101
Drug: Placebo
Enrollment 76

Recruitment Details  
Pre-assignment Details  
Arm/Group Title CF101 1 mg Twice Daily (BID) CF101 2 mg BID CF101 4 mg BID Placebo
Hide Arm/Group Description Oral tablets given every 12 hours for 12 weeks Oral tablets given every 12 hours for 12 weeks Oral tablets given every 12 hours for 12 weeks Oral tablets given every 12 hours for 12 weeks
Period Title: Overall Study
Started 25 [1] 17 15 19
Completed 17 17 14 16
Not Completed 8 0 1 3
[1]
one patient was randomized but never received study treatment
Arm/Group Title CF101 1 mg Twice Daily (BID) CF101 2 mg BID CF101 4 mg BID Placebo Total
Hide Arm/Group Description Oral tablets given every 12 hours for 12 weeks Oral tablets given every 12 hours for 12 weeks Oral tablets given every 12 hours for 12 weeks Oral tablets given every 12 hours for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 24 17 15 19 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 17 participants 15 participants 19 participants 75 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  79.2%
16
  94.1%
14
  93.3%
17
  89.5%
66
  88.0%
>=65 years
5
  20.8%
1
   5.9%
1
   6.7%
2
  10.5%
9
  12.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 17 participants 15 participants 19 participants 75 participants
51.5  (12.0) 48.4  (10.2) 45.3  (12.1) 51.2  (10.4) 49.5  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 17 participants 15 participants 19 participants 75 participants
Female
5
  20.8%
2
  11.8%
5
  33.3%
5
  26.3%
17
  22.7%
Male
19
  79.2%
15
  88.2%
10
  66.7%
14
  73.7%
58
  77.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Israel Number Analyzed 24 participants 17 participants 15 participants 19 participants 75 participants
24 17 15 19 75
1.Primary Outcome
Title Change From Baseline (CFB) in Psoriasis Area and Severity Index (PASI) Score
Hide Description PASI scale is sum of redness, thickness, and scale scores, ranging from 0 (no disease) to 72 (most severe possible score); lower scores, i..e., negative change from baseline, indicate improvement
Time Frame 12 weeks minus baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CF101 1 mg Twice Daily (BID) CF101 2 mg BID CF101 4 mg BID Placebo
Hide Arm/Group Description:
Oral tablets given every 12 hours for 12 weeks
Oral tablets given every 12 hours for 12 weeks
Oral tablets given every 12 hours for 12 weeks
Oral tablets given every 12 hours for 12 weeks
Overall Number of Participants Analyzed 24 17 15 19
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.67  (8.9) -8.8  (7.0) -4.1  (7.8) -2.7  (9.4)
2.Primary Outcome
Title Frequency and Nature of Adverse Events
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title The Number of Patients Who Achieve a Score of "Almost Clear" or "Clear" by Physician's Global Assessment (PGA)
Hide Description PGA is a scale from 0 (clear, no disease) to 5 (most severe score); patients who improve to 0 (clear) or 1 (minimal disease) are tabulated in this outcome
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CF101 1 mg BID CF101 2 mg BID CF101 4 mg BID Placebo
Hide Arm/Group Description:
Oral tablets given every 12 hours for 12 weeks
Oral tablets given every 12 hours for 12 weeks
Oral tablets given every 12 hours for 12 weeks
Oral tablets given every 12 hours for 12 weeks
Overall Number of Participants Analyzed 24 17 15 19
Measure Type: Number
Unit of Measure: Number of treated patients
0 4 1 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CF101 2 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Individual PASI Components Redness, Thickness, and Scale
Hide Description Each component is scored as 0 (clear, no disease) to 24 (most severe score); lower scores indicate improvement
Time Frame 12 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Relationship Between Peripheral Blood Mononuclear Cell Adenosine A3 Receptor (A3AR) Expression Level at Baseline and Response to Therapy.
Hide Description A3AR is measured biochemically and the expression level on cells from patients with disease is compared to that from healthy volunteer levels and expressed as a ratio
Time Frame 12 weeks
Outcome Measure Data Not Reported
Time Frame 14 weeks
Adverse Event Reporting Description All adverse events were collected and verbatim terms were coded via MedDRA dictionary
 
Arm/Group Title CF101 1 mg Twice Daily (BID) CF101 2 mg BID CF101 4 mg BID Placebo
Hide Arm/Group Description Oral tablets given every 12 hours for 12 weeks Oral tablets given every 12 hours for 12 weeks Oral tablets given every 12 hours for 12 weeks Oral tablets given every 12 hours for 12 weeks
All-Cause Mortality
CF101 1 mg Twice Daily (BID) CF101 2 mg BID CF101 4 mg BID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CF101 1 mg Twice Daily (BID) CF101 2 mg BID CF101 4 mg BID Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/17 (0.00%)      0/15 (0.00%)      1/19 (5.26%)    
Cardiac disorders         
Atrial fibrillation  1  0/24 (0.00%)  0 0/17 (0.00%)  0 0/15 (0.00%)  0 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CF101 1 mg Twice Daily (BID) CF101 2 mg BID CF101 4 mg BID Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/24 (8.33%)      1/17 (5.88%)      1/15 (6.67%)      1/19 (5.26%)    
Ear and labyrinth disorders         
Otitis externa  1  0/24 (0.00%)  0 1/17 (5.88%)  1 0/15 (0.00%)  0 0/19 (0.00%)  0
General disorders         
Chills  1  0/24 (0.00%)  0 0/17 (0.00%)  0 0/15 (0.00%)  0 1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders         
Arthropathy  1  2/24 (8.33%)  2 0/17 (0.00%)  0 0/15 (0.00%)  0 0/19 (0.00%)  0
Back pain  1  0/24 (0.00%)  0 0/17 (0.00%)  0 0/15 (0.00%)  0 1/19 (5.26%)  1
Renal and urinary disorders         
Urine oxalate  1  0/24 (0.00%)  0 0/17 (0.00%)  0 1/15 (6.67%)  1 0/19 (0.00%)  0
Reproductive system and breast disorders         
Uterine bleeding  1  0/24 (0.00%)  0 0/17 (0.00%)  0 1/15 (6.67%)  1 0/19 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Sinusitis  1  0/24 (0.00%)  0 0/17 (0.00%)  0 1/15 (6.67%)  1 0/19 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Pnina Fishman, PhD
Organization: Can-Fite BioPharma Ltd
Phone: 011972 3 924 1114
Responsible Party: Can-Fite BioPharma
ClinicalTrials.gov Identifier: NCT00428974     History of Changes
Other Study ID Numbers: CF101-201PS
First Submitted: January 29, 2007
First Posted: January 30, 2007
Results First Submitted: June 20, 2011
Results First Posted: September 26, 2011
Last Update Posted: January 25, 2018