Clinical trial NCT01265667: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Plaque Psoriasis
Keywords: Psoriasis
Plaque psoriasis
Lead sponsor: Can-Fite BioPharma
Sponsor class: INDUSTRY
First posted: 2010-12-23
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Subjects Achieving PGA of 0 or 1
timeFrame: 16 weeks
measure: Numberof Patients Achieving Psoriasis Area and Severity (PASI) Score of 50 or 75
timeFrame: 16 weeks
measure: Nature and Frequency of Adverse Events
timeFrame: 32 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Pleven
country: Bulgaria
facility: UMHAT "G.stranski"
city: Sofia,
country: Bulgaria
facility: MHAT "Tokuda hospital Sofia"
city: Sofia,
country: Bulgaria
facility: DCC "Fokus-5"-MIOC, EOOD
city: Sofia
country: Bulgaria
facility: Military Medical Acdemy (MMA)
city: Sofia
country: Bulgaria
facility: MHAT "Doverie"
city: Sofia
country: Bulgaria
facility: City Center for Skin and Venereal Disease
city: Stara Zagora
country: Bulgaria
facility: Multiprofile Hospital for Active Ttreatment
city: Varna,
country: Bulgaria
facility: MHAT Varna at MMA Sofia
city: Afula
country: Israel
facility: Haemek Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Petah Tiqva
country: Israel
facility: Rabin Medical Center
city: Bucuresti
country: Romania
facility: Centrul Medical Euromed
city: Bucuresti
country: Romania
facility: Spitalul Clinic Dermato-Venerice
city: Cluj-Napoca
country: Romania
facility: Emergency County Clinical Hospital
city: Constanta,
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Constanta
city: Iasi
country: Romania
facility: Spit Clinic Judetean de Urgenta Sf Spiridon Iasi
city: Sibiu
country: Romania
facility: County Clinical Emergency Hospital
Study officials:
affiliation: Can-Fite BioPharma
name: Michael H Silverman, MD
role: STUDY_DIRECTOR
References: