Safety and Efficacy Study of CF101 to Treat Psoriasis

NCT00428974 | Completed Phase 2 Results

• 1 other identifier: CF101-201PS
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Plaque Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (CFB) in Psoriasis Area and Severity Index (PASI) Score

  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

  12 weeks minus baseline

Secondary Outcomes (1)

• The Number of Patients Who Achieve a Score of "Almost Clear" or "Clear" by Physician's Global Assessment (PGA)

  12 weeks

Study Arms (4)

CF101 1 mg

EXPERIMENTAL

Drug: CF101 1mg

CF101 2mg

EXPERIMENTAL

Drug: CF101 2mg

CF101 4mg

EXPERIMENTAL

Drug: CF101 4mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CF101 1mg DRUG

CF101 1 mg q12 hours for 12 weeks

Also known as: IB-MECA

CF101 1 mg

CF101 2mg DRUG

CF101 2 mg q12 hours for 12 weeks

Also known as: IB-MECA

CF101 2mg

CF101 4mg DRUG

CF101 4 mg q12 hours for 12 weeks

Also known as: IB-MECA

CF101 4mg

Placebo DRUG

Placebo tablets q12 hours for 12 weeks

Also known as: Inactive pill

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Can-Fite BioPharma: lead

Study Sites (4)

Haemek Medical Center

Afula, Israel

Location

Wolfson Medical Center

Holon, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Sheba Medical Center

Tel Litwinsky, Israel

Location

Related Publications (1)

• David M, Akerman L, Ziv M, Kadurina M, Gospodinov D, Pavlotsky F, Yankova R, Kouzeva V, Ramon M, Silverman MH, Fishman P. Treatment of plaque-type psoriasis with oral CF101: data from an exploratory randomized phase 2 clinical trial. J Eur Acad Dermatol Venereol. 2012 Mar;26(3):361-7. doi: 10.1111/j.1468-3083.2011.04078.x. Epub 2011 Apr 20.

  PMID: 21504485 RESULT

MeSH Terms

Conditions

Psoriasis

Interventions

CF101; N(6)-(3-iodobenzyl)-5'-N-methylcarboxamidoadenosine

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pnina Fishman, PhD
• Organization: Can-Fite BioPharma Ltd

pnina@canfite.co.il

011972 3 924 1114

Study Officials

• Michael David, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

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: January 29, 2007
• First Posted: January 30, 2007
• Study Start: June 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 8, 2023
• Results First Posted: September 26, 2011

Record last verified: 2023-02

Locations

IL (4)