Clinical Trials Logo
  1. Home
  2. Plaque Psoriasis
  3. NCT00428974

Safety and Efficacy Study of CF101 to Treat Psoriasis

Plaque Psoriasis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00428974
Study type Interventional
Source Can-Fite BioPharma
Contact
Status Completed
Phase Phase 2
Start date June 2007
Completion date September 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT01194219 - Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis Phase 3
Recruiting NCT06030076 - A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis
Completed NCT04263610 - Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy Phase 4
Completed NCT02601469 - Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis Phase 2
Completed NCT05600036 - A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis Phase 2
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03614078 - A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis Phase 2
Not yet recruiting NCT05036889 - A 16-week Randomized Evaluation of the Impact of Mind.Px Application on Response to Biologic Treatment in Patients Suffering From Plaque Psoriasis Through Clinical Utility and Health Outcomes. N/A
Completed NCT04603027 - A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis Phase 2
Completed NCT03638258 - The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis Phase 2
Completed NCT02881346 - Efficacy and Tolerability of Enstilar® in Daily Practice
Recruiting NCT02611349 - Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis Phase 3
Completed NCT02251678 - Evaluate the Effect of Elimune Capsules Phase 1
Completed NCT01987843 - Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 2
Terminated NCT01708629 - Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects Phase 3
Withdrawn NCT00747032 - To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis Phase 3
Completed NCT01230138 - Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis Phase 2
Completed NCT00581100 - Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis Phase 4
Suspended NCT01228656 - Effectiveness of Association Mometasone Furoate 0.1% and Salicylic Acid 5% Compared With Mometasone Furoate Phase 2
Completed NCT00540618 - A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis Phase 2