NCT00428974

Safety and Efficacy Study of CF101 to Treat Psoriasis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Can-Fite BioPharma · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	CF101 1mg	CF101 1 mg q12 hours for 12 weeks
DRUG	CF101 2mg	CF101 2 mg q12 hours for 12 weeks
DRUG	CF101 4mg	CF101 4 mg q12 hours for 12 weeks
DRUG	Placebo	Placebo tablets q12 hours for 12 weeks

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2007-01-30
• Last updated: 2023-02-08
• Results posted: 2011-09-26

Locations

4 sites across 1 country: Israel