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Trial of CF101 to Treat Patients With Psoriasis

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CF101
Placebo
Sponsored by
Can-Fite BioPharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring Psoriasis, Plaque psoriasis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mount Sinai School of Medicine
  • UMHAT "G.stranski"
  • MHAT "Tokuda hospital Sofia"
  • DCC "Fokus-5"-MIOC, EOOD
  • Military Medical Acdemy (MMA)
  • MHAT "Doverie"
  • City Center for Skin and Venereal Disease
  • Multiprofile Hospital for Active Ttreatment
  • MHAT Varna at MMA Sofia
  • Haemek Medical Center
  • Rambam Medical Center
  • Rabin Medical Center
  • Centrul Medical Euromed
  • Spitalul Clinic Dermato-Venerice
  • Emergency County Clinical Hospital
  • Spitalul Clinic Judetean de Urgenta Constanta
  • Spit Clinic Judetean de Urgenta Sf Spiridon Iasi
  • County Clinical Emergency Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CF101 2 mg

Placebo

Arm Description

CF101 2mg oral tablets

Placebo oral tablets

Outcomes

Primary Outcome Measures

Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 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

Number of Subjects Achieving PGA of 0 or 1
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
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
Assessment of safety of CF101 in this patient population by gathering adverse event data based on history, vital signs, physical examination, and laboratory data

Full Information

First Posted
December 9, 2010
Last Updated
October 31, 2020
Sponsor
Can-Fite BioPharma
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1. Study Identification

Unique Protocol Identification Number
NCT01265667
Brief Title
Trial of CF101 to Treat Patients With Psoriasis
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 Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Can-Fite BioPharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Psoriasis, Plaque psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
293 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CF101 2 mg
Arm Type
Experimental
Arm Description
CF101 2mg oral tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral tablets
Intervention Type
Drug
Intervention Name(s)
CF101
Other Intervention Name(s)
IB-MECA
Intervention Description
orally q12h
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Dummy pills
Intervention Description
orally q12h
Primary Outcome Measure Information:
Title
Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks
Description
Achievement of PASI 75 indicates a 75% reduction in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Subjects Achieving PGA of 0 or 1
Description
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)
Time Frame
16 weeks
Title
Numberof Patients Achieving Psoriasis Area and Severity (PASI) Score of 50 or 75
Description
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)
Time Frame
16 weeks
Title
Nature and Frequency of Adverse Events
Description
Assessment of safety of CF101 in this patient population by gathering adverse event data based on history, vital signs, physical examination, and laboratory data
Time Frame
32 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Silverman, MD
Organizational Affiliation
Can-Fite BioPharma
Official's Role
Study Director
Facility Information:
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
Country
United States
Facility Name
UMHAT "G.stranski"
City
Pleven
ZIP/Postal Code
5800,
Country
Bulgaria
Facility Name
MHAT "Tokuda hospital Sofia"
City
Sofia,
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
DCC "Fokus-5"-MIOC, EOOD
City
Sofia,
ZIP/Postal Code
1463
Country
Bulgaria
Facility Name
Military Medical Acdemy (MMA)
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
MHAT "Doverie"
City
Sofia
ZIP/Postal Code
1632,
Country
Bulgaria
Facility Name
City Center for Skin and Venereal Disease
City
Sofia
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Ttreatment
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
MHAT Varna at MMA Sofia
City
Varna,
ZIP/Postal Code
9010,
Country
Bulgaria
Facility Name
Haemek Medical Center
City
Afula
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tiqva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Centrul Medical Euromed
City
Bucuresti
Country
Romania
Facility Name
Spitalul Clinic Dermato-Venerice
City
Bucuresti
Country
Romania
Facility Name
Emergency County Clinical Hospital
City
Cluj-Napoca
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Constanta
City
Constanta,
ZIP/Postal Code
900622
Country
Romania
Facility Name
Spit Clinic Judetean de Urgenta Sf Spiridon Iasi
City
Iasi
ZIP/Postal Code
700368,
Country
Romania
Facility Name
County Clinical Emergency Hospital
City
Sibiu
Country
Romania

12. IPD Sharing Statement

Links:
URL
http://www.canfite.com/
Description
Can-Fite BioPharma website

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Trial of CF101 to Treat Patients With Psoriasis

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