Trial record 7 of 12 for:    CF101

Trial of CF101 to Treat Patients With Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01265667
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : September 20, 2017
Last Update Posted : September 20, 2017
Information provided by (Responsible Party):
Can-Fite BioPharma

Brief Summary:
Eligible patients with Psoriasis will be treated with CF101 or placebo twice daily for 16 weeks. All subjects will receive open-lable CF101 in weeks 17-32.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: CF101 Drug: Placebo Phase 2 Phase 3

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: CF101 2 mg Drug: CF101
orally q12h
Other Name: IB-MECA

Placebo Comparator: Placebo Drug: Placebo
orally q12h
Other Name: Dummy pills

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, 18 to 80 years of age, inclusive
  • Diagnosis of moderate-to-severe chronic plaque-type psoriasis with body surface area involvement ≥10%
  • Duration of psoriasis of at least 6 months
  • Physician global assessment (PGA) ≥3
  • Candidate for systemic treatment or phototherapy for psoriasis
  • Electrocardiogram (ECG) is normal
  • Females of child-bearing potential must have a negative serum pregnancy test
  • Females of child-bearing potential must be willing to use 2 methods of contraception
  • Ability to complete the study in compliance with the protocol
  • Ability to understand and provide written informed consent.

Exclusion Criteria:

  • Erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis
  • Treatment with systemic retinoids, corticosteroids, or immunosuppressive agents within 4 weeks of the Baseline visit
  • Treatment with high potency topical corticosteroids, keratolytics, or coal tar within 2 weeks of the Baseline visit
  • Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit
  • Treatment with a biological agent within a period of time equal to 5 times its circulating half-life
  • Treatment with lithium, hydroxychloroquine or chloroquine within 2 weeks of the Baseline visit
  • Serum creatinine level greater than 1.5 times the laboratory's upper limit of normal
  • Liver aminotransferase levels greater than the laboratory's upper limit of normal
  • Significant acute or chronic medical or psychiatric illness
  • Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to Screening visit.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01265667

United States, New York
Mount Sinai School of Medicine
New York, New York, United States
UMHAT "G.stranski"
Pleven, Bulgaria, 5800,
MHAT "Tokuda hospital Sofia"
Sofia,, Bulgaria, 1407
DCC "Fokus-5"-MIOC, EOOD
Sofia,, Bulgaria, 1463
Military Medical Acdemy (MMA)
Sofia, Bulgaria, 1606
MHAT "Doverie"
Sofia, Bulgaria, 1632,
City Center for Skin and Venereal Disease
Sofia, Bulgaria
Multiprofile Hospital for Active Ttreatment
Stara Zagora, Bulgaria, 6003
MHAT Varna at MMA Sofia
Varna,, Bulgaria, 9010,
Haemek Medical Center
Afula, Israel
Rambam Medical Center
Haifa, Israel, 31096
Rabin Medical Center
Petah Tiqva, Israel, 49100
Centrul Medical Euromed
Bucuresti, Romania
Spitalul Clinic Dermato-Venerice
Bucuresti, Romania
Emergency County Clinical Hospital
Cluj-Napoca, Romania
Spitalul Clinic Judetean de Urgenta Constanta
Constanta,, Romania, 900622
Spit Clinic Judetean de Urgenta Sf Spiridon Iasi
Iasi, Romania, 700368,
County Clinical Emergency Hospital
Sibiu, Romania
Sponsors and Collaborators
Can-Fite BioPharma
Study Director: Michael H Silverman, MD Can-Fite BioPharma

Additional Information:
Responsible Party: Can-Fite BioPharma Identifier: NCT01265667     History of Changes
Other Study ID Numbers: CF101-202PS
First Posted: December 23, 2010    Key Record Dates
Results First Posted: September 20, 2017
Last Update Posted: September 20, 2017
Last Verified: July 2017

Keywords provided by Can-Fite BioPharma:
Plaque psoriasis

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases