Trial of CF101 to Treat Patients With Psoriasis

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265667
• Other study ID #: CF101-202PS
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2011
• Est. completion date: May 2015

Study information

• Verified date: October 2020
• Source: Can-Fite BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• CF101
orally q12h
• Placebo
orally q12h

Locations

Country	Name	City	State
Bulgaria	UMHAT "G.stranski"	Pleven
Bulgaria	City Center for Skin and Venereal Disease	Sofia
Bulgaria	MHAT "Doverie"	Sofia
Bulgaria	Military Medical Acdemy (MMA)	Sofia
Bulgaria	DCC "Fokus-5"-MIOC, EOOD	Sofia,
Bulgaria	MHAT "Tokuda hospital Sofia"	Sofia,
Bulgaria	Multiprofile Hospital for Active Ttreatment	Stara Zagora
Bulgaria	MHAT Varna at MMA Sofia	Varna,
Israel	Haemek Medical Center	Afula
Israel	Rambam Medical Center	Haifa
Israel	Rabin Medical Center	Petah Tiqva
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	Spit Clinic Judetean de Urgenta Sf Spiridon Iasi	Iasi
Romania	County Clinical Emergency Hospital	Sibiu
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Can-Fite BioPharma

Countries where clinical trial is conducted

United States,  Bulgaria,  Israel,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   Can-Fite BioPharma website