CF101 Therapy in Patients With Moderate-to-severe Plaque Psoriasis

Summary

This trial will test the hypothesis that the administration of CF101, a novel anti-inflammatory agent, to patients with moderate to severe plaque psoriasis will relieve signs and symptoms of the disease. CF101 effect will be in comparison to apremilast in this study population

Timeline

Start

2018-09-15

Primary completion

2022-01-06

Completion

2022-04-27

Outcome

Met primary endpoint

paper The primary end point was met with the 3 mg BID dose: PASI 75 rate of 9.7% versus 2.6% for piclidenoson versus placebo, p = 0.037. PMID 38279575 ↗

release “Can-Fite previously reported the COMFORT™ study met its primary endpoint with Piclidenoson showing a statistically significant improvement over placebo in psoriasis patients.” canfite.com ↗

release “COMFORT-1 trial. As previously reported, the study met its primary endpoint” canfite.com ↗

Publications

• Papp KA, Beyska-Rizova S, Gantcheva ML, Slavcheva Simeonova E, Brezoev P, Celic M, Groppa L, Blicharski T, Selmanagic A, Kalicka-Dudzik M, Calin CA, Trailovic N, Ramon M, Bareket-Samish A, Harpaz Z, Farbstein M, Silverman MH, Fishman P; COMFORT-1 Study Investigators. Efficacy and safety of piclidenoson in plaque psoriasis: Results from a randomized phase 3 clinical trial (COMFORT-1). J Eur Acad Dermatol Venereol. 2024 Jun;38(6):1112-1120. doi: 10.1111/jdv.19811. Epub 2024 Jan 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Apremilast	Small molecule	30 mg	Oral
Subject	Piclidenoson	Small molecule	2 mg	Oral
Subject	Piclidenoson	Small molecule	3 mg	Oral

Indications