Safety and Efficacy Study of CF101 to Treat Psoriasis

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.

Timeline

Start

2007-06

Primary completion

2009-09

Completion

2009-09

Outcome

Met primary endpoint

registry analysis (superiority test); CF101 2 mg BID vs Placebo; p = 0.031; t-test, 1 sided NCT00428974 ↗

Publications

• Results 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.

Drugs

Indications