Safety and Efficacy Study of CF101 to Treat Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Can-Fite BioPharma
ClinicalTrials.gov Identifier:
NCT00428974
First received: January 29, 2007
Last updated: August 18, 2011
Last verified: August 2011
  Purpose

This study will test the hypothesis that CF101, which is under development to treat other immune-mediated inflammatory diseases, will provide clinical benefits in the treatment of chronic plaque psoriasis. Patients with psoriasis who qualify for the study will be treated every 12 hours (q12h) with CF101 capsules, or placebo capsules, for 12 weeks. The safety of treatment will be carefully assessed through clinical and laboratory monitoring. The effect of treatment on psoriasis will be evaluated through standard techniques of examination and measurement of the severity of skin involvement.


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

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, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study of the Safety and Activity 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:
  • Change From Baseline (CFB) in Psoriasis Area and Severity Index (PASI) Score [ Time Frame: 12 weeks minus baseline ] [ Designated as safety issue: No ]
    PASI scale is sum of redness, thickness, and scale scores, ranging from 0 (no disease) to 72 (most severe possible score); lower scores, i..e., negative change from baseline, indicate improvement

  • Frequency and Nature of Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Number of Patients Who Achieve a Score of "Almost Clear" or "Clear" by Physician's Global Assessment (PGA) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    PGA is a scale from 0 (clear, no disease) to 5 (most severe score); patients who improve to 0 (clear) or 1 (minimal disease) are tabulated in this outcome

  • Individual PASI Components Redness, Thickness, and Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Each component is scored as 0 (clear, no disease) to 24 (most severe score); lower scores indicate improvement

  • Relationship Between Peripheral Blood Mononuclear Cell Adenosine A3 Receptor (A3AR) Expression Level at Baseline and Response to Therapy. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    A3AR is measured biochemically and the expression level on cells from patients with disease is compared to that from healthy volunteer levels and expressed as a ratio


Enrollment: 76
Study Start Date: June 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: CF101
CF101 1 mg q12 hours for 12 weeks
Other Name: IB-MECA
Experimental: 2 Drug: CF101
CF101 2 mg q12 hours for 12 weeks
Other Name: IB-MECA
Experimental: 3 Drug: CF101
CF101 4 mg q12 hours for 12 weeks
Other Name: IB-MECA
Placebo Comparator: 4 Drug: Placebo
Placebo tablets q12 hours for 12 weeks
Other Name: Inactive pill

Detailed Description:

This is a Phase 2, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study in adult males and females, ages 18 to 70 years, inclusive, with a diagnosis of moderate-to-severe chronic plaque psoriasis. At the Screening Visit, patients who provide written informed consent will have screening procedures performed, including a complete medical history, medication history, physical examination, including height, weight, blood pressure, pulse rate and temperature, and clinical laboratory tests.

Eligible patients will be those who have not received systemic retinoids, corticosteroids, or immunosuppressants (e.g., methotrexate, cyclosporine) within 6 weeks prior to initiation of study; or high potency topical corticosteroids (Class I-III), keratolytics, or coal tar (other than on the scalp, palms, groin, and/or soles); and UV or Dead Sea therapy within 4 weeks prior to initiation of study treatment. Eligible patients will be sequentially assigned to 1 of 3 dosing cohorts:

Cohort 1: CF101 1 mg (15 patients) or Placebo (5 patients); Cohort 2: CF101 2 mg (15 patients) or Placebo (5 patients); Cohort 3: CF101 4 mg (15 patients) or Placebo (5 patients).

Medication will be taken orally q12h for 12 weeks. Disease activity will be assessed using the Psoriasis Area and Severity Index (PASI) and the Physician Global Assessment (PGA). Patients will return for assessments at Weeks 2, 4, 8, 12 and 14.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, 18 to 70 years of age, inclusive;
  • Diagnosis of moderate-to-severe chronic plaque-type psoriasis with body surface area involvement ≥10%, as judged by the Investigator;
  • Duration of psoriasis of at least 6 months;
  • PASI score ≥10;
  • Body weight ≤100 kg;
  • Candidate for systemic treatment or phototherapy for psoriasis;
  • ECG is normal or shows abnormalities which, in the judgment of the Investigator, are not clinically significant;
  • Females of child-bearing potential must have a negative serum pregnancy test at screening;
  • Females of child-bearing potential must be willing to use 2 methods of contraception deemed adequate by the Investigator (for example oral contraceptive pills plus a barrier method) to be eligible for, and continue participation in, the study;
  • Ability to complete the study in compliance with the protocol; and
  • Ability to understand and provide written informed consent.

Exclusion Criteria:

  • Erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis;
  • Treatment with systemic retinoids, corticosteroids, or immunosuppressants (e.g., methotrexate, cyclosporine) within 6 weeks of the Baseline visit;
  • Treatment with high potency topical corticosteroids (Class I-III), keratolytics, or coal tar (other than on the scalp, palms, groin, and/or soles) within 2 weeks of the Baseline visit;
  • Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit, or anticipated need for either of these therapies during the study period;
  • Treatment with a biological agent (including etanercept, adalimumab, efalizumab, infliximab, or alefacept) within a period of time equal to 5 times its circulating half-life, or 30 days, whichever is longer, prior to the Baseline visit;
  • History of poor clinical response to methotrexate after an adequate regimen and duration of treatment;
  • Treatment with systemic nonsteroidal anti-inflammatory drugs, beta-blockers, lithium, hydroxychloroquine, chloroquine, or systemic terbinafine within 2 weeks of the Baseline visit, or anticipated need for such drugs during the study period;
  • Presence or history of uncontrolled asthma;
  • Presence or history of uncontrolled arterial hypertension or symptomatic hypotension;
  • Significant cardiac arrhythmia or conduction block, congestive heart failure (New York Heart Association Class 3-4), or any other evidence of clinically significant heart disease or clinically significant findings on screening electrocardiogram;
  • Hemoglobin level <9.0 gm/L;
  • Platelet count <125,000/mm^3;
  • White blood cell count <3500/mm^3;
  • Serum creatinine level greater than 1.5 times the laboratory's upper limit of normal;
  • Liver aminotransferase levels greater than 2 times the laboratory's upper limit of normal;
  • Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the Investigator;
  • History of malignancy within the past 5 years (excluding basal cell carcinoma of the skin and ≤3 cutaneous squamous cell carcinomas, all of which have been completely excised);
  • Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study;
  • Participation in another investigational drug or vaccine trial concurrently or within 30 days; or within 5 half lives of a biological investigational product, whichever is longer;
  • Other conditions which would confound the study evaluations or endanger the safety of the patient.
  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: NCT00428974

Locations
Israel
Haemek Medical Center
Afula, Israel
Wolfson Medical Center
Holon, Israel
Rabin Medical Center
Petach Tikva, Israel
Sheba Medical Center
Tel-Hashomer, Israel
Sponsors and Collaborators
Can-Fite BioPharma
Investigators
Principal Investigator: Michael David, MD Rabin Medical Center
  More Information

Publications:
Responsible Party: Can-Fite BioPharma
ClinicalTrials.gov Identifier: NCT00428974     History of Changes
Other Study ID Numbers: CF101-201PS
Study First Received: January 29, 2007
Results First Received: June 20, 2011
Last Updated: August 18, 2011
Health Authority: Israel: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Can-Fite BioPharma:
Psoriasis

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

ClinicalTrials.gov processed this record on October 23, 2014