Trial of CF101 to Treat Patients With Psoriasis

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

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: CF101; Drug: Placebo

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
• Enrollment (Actual): 293
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CF101 2 mg; CF101 2mg oral tablets	Drug: CF101; orally q12h; Other Names: IB-MECA
Placebo Comparator: Placebo; Placebo oral tablets	Drug: Placebo; orally q12h; Other Names: Dummy pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	16 weeks
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)	16 weeks
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	32 weeks

Collaborators and Investigators

• Sponsor: Can-Fite BioPharma
• Investigators: Study Director: Michael H Silverman, MD, Can-Fite BioPharma

Publications and helpful links

Helpful Links

• Can-Fite BioPharma website

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: December 9, 2010
• First Submitted That Met QC Criteria: December 22, 2010
• First Posted (Estimate): December 23, 2010

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: October 31, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Psoriasis; Plaque psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CF101-202PS