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Trial of CF101 to Treat Patients With Psoriasis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Can-Fite BioPharma
ClinicalTrials.gov Identifier:
NCT01265667
First received: December 9, 2010
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Plaque Psoriasis
Drug: CF101
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Can-Fite BioPharma:

Primary Outcome Measures:
  • Proportion of subjects achieving PASI 75 at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving PGA of 0 or 1 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Proportions of patients achieving Psoriasis Area and Severity (PASI) score of 50 and 75 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Nature and frequency of adverse events [ Time Frame: 32 weeks ] [ Designated as safety issue: Yes ]
    Assessment of safety of CF101 in this patient population by gathering adverse event data based on history, vital signs, physical examination, and laboratory data


Estimated Enrollment: 188
Study Start Date: July 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CF101 2 mg Drug: CF101
orally q12h
Other Name: IB-MECA
Placebo Comparator: Placebo Drug: Placebo
orally q12h
Other Name: Dummy pills

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • PGA ≥3
  • Candidate for systemic treatment or phototherapy for psoriasis
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265667

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States
Bulgaria
UMHAT "G.stranski"
Pleven, Bulgaria, 5800,
Military Medical Acdemy (MMA)
Sofia, Bulgaria, 1606
City Center for Skin and Venereal Disease
Sofia, Bulgaria
MHAT "Doverie"
Sofia, Bulgaria, 1632,
MHAT "Tokuda hospital Sofia"
Sofia,, Bulgaria, 1407
DCC "Fokus-5"-MIOC, EOOD
Sofia,, Bulgaria, 1463
Multiprofile Hospital for Active Ttreatment
Stara Zagora, Bulgaria, 6003
MHAT Varna at MMA Sofia
Varna,, Bulgaria, 9010,
Israel
Haemek Medical Center
Afula, Israel
Rambam Medical Center
Haifa, Israel, 31096
Rabin Medical Center
Petah Tiqva, Israel, 49100
Romania
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
Investigators
Study Director: Michael H Silverman, MD Can-Fite BioPharma
  More Information

Additional Information:
No publications provided

Responsible Party: Can-Fite BioPharma
ClinicalTrials.gov Identifier: NCT01265667     History of Changes
Other Study ID Numbers: CF101-202PS
Study First Received: December 9, 2010
Last Updated: July 30, 2014
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Romania: National Medicines Agency

Keywords provided by Can-Fite BioPharma:
Psoriasis
Plaque psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 27, 2014