Trial Outcomes & Findings for Trial of CF101 to Treat Patients With Psoriasis (NCT NCT01265667)

NCT ID: NCT01265667

Last Updated: 2020-11-18

Results Overview

Achievement of PASI 75 indicates a 75% reduction in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 293 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2020-11-18

Participant Flow

Participant milestones

Measure	CF101 2 mg CF101: orally q12h	Placebo Placebo: orally q12h
Overall Study STARTED	145	148
Overall Study COMPLETED	125	135
Overall Study NOT COMPLETED	20	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of CF101 to Treat Patients With Psoriasis

Baseline characteristics by cohort

Measure	CF101 2mg n=145 Participants Oral tablets given every 12 hours for 16 weeks	Placebo n=148 Participants Oral tablets given every 12 hours for 16 weeks	Total n=293 Participants Total of all reporting groups
Age, Continuous	48.3 years STANDARD_DEVIATION 13.57 • n=5 Participants	50.0 years STANDARD_DEVIATION 13.96 • n=7 Participants	49.2 years STANDARD_DEVIATION 13.77 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	53 Participants n=7 Participants	107 Participants n=5 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	95 Participants n=7 Participants	186 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Analysis was performed on the Intent-to-treat (ITT) Population

Achievement of PASI 75 indicates a 75% reduction in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)

Outcome measures

Measure	CF101 2 mg n=141 Participants CF101: orally q12h	Placebo n=144 Participants Placebo: orally q12h
Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks	12 Participants	10 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Analysis was performed on the ITT population

PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe)

Outcome measures

Measure	CF101 2 mg n=141 Participants CF101: orally q12h	Placebo n=144 Participants Placebo: orally q12h
Number of Subjects Achieving PGA of 0 or 1	9 participants	5 participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Analysis performed of the ITT population

Achievement of PASI 50 or 75 indicates a 50% and 75% reduction respectively in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)

Outcome measures

Measure	CF101 2 mg n=141 Participants CF101: orally q12h	Placebo n=144 Participants Placebo: orally q12h
Numberof Patients Achieving Psoriasis Area and Severity (PASI) Score of 50 or 75	31 participants	17 participants

SECONDARY outcome

Timeframe: 32 weeks

Assessment of safety of CF101 in this patient population by gathering adverse event data based on history, vital signs, physical examination, and laboratory data

Outcome measures

Measure	CF101 2 mg n=145 Participants CF101: orally q12h	Placebo n=148 Participants Placebo: orally q12h
Nature and Frequency of Adverse Events Nervous system disorders	6 Participants	0 Participants
Nature and Frequency of Adverse Events Any	37 Participants	29 Participants
Nature and Frequency of Adverse Events Gastrointestinal disorders	8 Participants	3 Participants
Nature and Frequency of Adverse Events Infections and infestations	10 Participants	13 Participants
Nature and Frequency of Adverse Events Musculoskeletal and connective tissue disorders	5 Participants	2 Participants
Nature and Frequency of Adverse Events Renal and urinary disorders	5 Participants	4 Participants

Adverse Events

CF101 2 mg

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CF101 2 mg n=145 participants at risk CF101: orally q12h	Placebo n=148 participants at risk Placebo: orally q12h
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 2/145 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary	0.00% 0/148 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary
Infections and infestations Influenza	0.00% 0/145 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary	1.4% 2/148 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary
Infections and infestations Nasopharyngitis	1.4% 2/145 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary	1.4% 2/148 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary
Infections and infestations Urinary tract infection	1.4% 2/145 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary	2.7% 4/148 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary
Gastrointestinal disorders Abdominal pain	1.4% 2/145 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary	0.68% 1/148 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary
Gastrointestinal disorders Diarrhoea	2.1% 3/145 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary	0.68% 1/148 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary
Gastrointestinal disorders Dry mouth	1.4% 2/145 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary	0.00% 0/148 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary
Gastrointestinal disorders Nausea	1.4% 2/145 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary	0.00% 0/148 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.69% 1/145 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary	1.4% 2/148 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary
Nervous system disorders Headache	2.8% 4/145 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary	0.00% 0/148 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary
Renal and urinary disorders Haematuria	1.4% 2/145 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary	1.4% 2/148 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary
Renal and urinary disorders Proteinuria	1.4% 2/145 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary	0.68% 1/148 • 16 weeks All adverse events were collected and verbatim terms were coded via MedDRA dictionary

Additional Information

Zivit Harpaz

Can-Fite BioPharma Ltd

Phone: 972-3-9241114

Email: zivit@canfite.co.il

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place