Trial of CF101 to Treat Patients With Psoriasis
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|ClinicalTrials.gov Identifier: NCT01265667|
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : September 20, 2017
Last Update Posted : September 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Drug: CF101 Drug: Placebo||Phase 2 Phase 3|
Eligible patients will be randomly assigned to parallel dosing groups of CF101 2 mg or matching placebo tablets twice daily (BID) in a 1:1 ratio for the 16-week controlled treatment period. Approximately 94 patients will be assigned to each group.
Medication will be taken orally BID for 16 weeks in a double-blinded fashion. At the end of 16 weeks, all patients assigned to CF101 will continue CF101, while patients originally assigned to placebo will be reassigned to CF101.
Assessment of peripheral blood mononuclear cell (PBMC) adenosine A3 receptor (A3AR) expression at baseline and during treatment with CF101 in selected sites.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||293 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of the Efficacy and Safety of Daily CF101 Administered Orally in Patients With Moderate-to-Severe Plaque Psoriasis|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||May 2015|
|Experimental: CF101 2 mg||
Other Name: IB-MECA
|Placebo Comparator: Placebo||
Other Name: Dummy pills
- Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks [ Time Frame: 12 weeks ]Achievement of PASI 75 indicates a 75% reduction in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)
- Number of Subjects Achieving PGA of 0 or 1 [ Time Frame: 16 weeks ]PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe)
- Numberof Patients Achieving Psoriasis Area and Severity (PASI) Score of 50 or 75 [ Time Frame: 16 weeks ]Achievement of PASI 50 or 75 indicates a 50% and 75% reduction respectively in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)
- Nature and Frequency of Adverse Events [ Time Frame: 32 weeks ]Assessment of safety of CF101 in this patient population by gathering adverse event data based on history, vital signs, physical examination, and laboratory data
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265667
|Study Director:||Michael H Silverman, MD||Can-Fite BioPharma|