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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

  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
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 
[1] one patient was randomized but never received study treatment



  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.
No text entered.

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]
Count of 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 
[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) 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: Participants]
         
Israel   24   17   15   19   75 


  Outcome Measures

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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Individual PASI Components Redness, Thickness, and Scale   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Relationship Between Peripheral Blood Mononuclear Cell Adenosine A3 Receptor (A3AR) Expression Level at Baseline and Response to Therapy.   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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 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
e-mail: pnina@canfite.co.il


Publications of Results:

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