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

Sponsor
Can-Fite BioPharma
Study ID
NCT03168256
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • CF101 2mg — DRUG
    CF101 tablets, 2mg BID for 16 weeks
  • CF101 3mg — DRUG
    CF101 tablets, 3mg BID for 16 weeks
  • Apremilast 30mg — DRUG
    Apremilast tablets, 30mg BID for 16 weeks
  • Placebo Oral Tablet — DRUG
    Placebo tablets, BID for 16 weeks

Study Details

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

Key Dates

First listed
May 30, 2017
Start date
Sep 15, 2018
Status verified
Jun 2022
Primary completion
Jan 6, 2022
Completion
Apr 27, 2022

Study Design

Enrollment
528 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CF101 2mg
    CF101 2mg, orally q12 hours
  • Experimental: CF101 3mg
    CF101 3mg, orally q12 hours
  • Active Comparator: Apremilast 30mg
    Apremilast 30mg, orally q12 hours
  • Placebo Comparator: Placebo
    Placebo control , orally q12 hours

Primary Outcome Measure

Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75) at Week 16 [ Time Frame: 16 weeks ]

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