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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

293

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jul 2011

Typical duration for phase_2

Geographic Reach

4 countries

18 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.8 years study duration

First Submitted

Initial submission to the registry

December 9, 2010

Completed

14 days until next milestone

First Posted

Study publicly available on registry

December 23, 2010

Completed

6 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed

3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed

2.4 years until next milestone

Results Posted

Study results publicly available

September 20, 2017

Completed

Last Updated

November 18, 2020

Status Verified

October 1, 2020

Enrollment Period

3.7 years

First QC Date

December 9, 2010

Results QC Date

June 1, 2017

Last Update Submit

October 31, 2020

Conditions

Plaque Psoriasis

Keywords

PsoriasisPlaque psoriasis

Outcome Measures

Primary Outcomes (1)

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 Outcomes (3)

Number of Subjects Achieving PGA of 0 or 1
16 weeks
Numberof Patients Achieving Psoriasis Area and Severity (PASI) Score of 50 or 75
16 weeks
Nature and Frequency of Adverse Events
32 weeks

Study Arms (2)

CF101 2 mg

EXPERIMENTAL

CF101 2mg oral tablets

Drug: CF101

Placebo

PLACEBO COMPARATOR

Placebo oral tablets

Drug: Placebo

Interventions

CF101DRUG

orally q12h

Also known as: IB-MECA

CF101 2 mg

PlaceboDRUG

orally q12h

Also known as: Dummy pills

Placebo

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Can-Fite BioPharmalead

Study Sites (18)

Mount Sinai School of Medicine

New York, New York, United States

Location

UMHAT "G.stranski"

Pleven, 5800,, Bulgaria

Location

MHAT "Tokuda hospital Sofia"

Sofia, 1407, Bulgaria

Location

DCC "Fokus-5"-MIOC, EOOD

Sofia, 1463, Bulgaria

Location

Military Medical Acdemy (MMA)

Sofia, 1606, Bulgaria

Location

MHAT "Doverie"

Sofia, 1632,, Bulgaria

Location

City Center for Skin and Venereal Disease

Sofia, Bulgaria

Location

Multiprofile Hospital for Active Ttreatment

Stara Zagora, 6003, Bulgaria

Location

MHAT Varna at MMA Sofia

Varna, 9010,, Bulgaria

Location

Haemek Medical Center

Afula, Israel

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Centrul Medical Euromed

Bucharest, Romania

Location

Spitalul Clinic Dermato-Venerice

Bucharest, Romania

Location

Emergency County Clinical Hospital

Cluj-Napoca, Romania

Location

Spitalul Clinic Judetean de Urgenta Constanta

Constanța, 900622, Romania

Location

Spit Clinic Judetean de Urgenta Sf Spiridon Iasi

Iași, 700368,, Romania

Location

County Clinical Emergency Hospital

Sibiu, Romania

Location

MeSH Terms

Conditions

Psoriasis

Interventions

CF101N(6)-(3-iodobenzyl)-5'-N-methylcarboxamidoadenosine

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title: Zivit Harpaz
Organization: Can-Fite BioPharma Ltd

Study Officials

Michael H Silverman, MD
Can-Fite BioPharma
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 9, 2010

First Posted

December 23, 2010

Study Start

July 1, 2011

Primary Completion

March 1, 2015

Study Completion

May 1, 2015

Last Updated

November 18, 2020

Results First Posted

September 20, 2017

Record last verified: 2020-10

Locations

US(1)BU(8)IL(3)RO(6)

Trial of CF101 to Treat Patients With Psoriasis

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

CF101 2 mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

CF101 2 mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations