Plaque Psoriasis
Conditions
Keywords
Psoriasis, Plaque psoriasis
Brief summary
Eligible patients with Psoriasis will be treated with CF101 or placebo twice daily for 16 weeks. All subjects will receive open-lable CF101 in weeks 17-32.
Detailed description
Eligible patients will be randomly assigned to parallel dosing groups of CF101 2 mg or matching placebo tablets twice daily (BID) in a 1:1 ratio for the 16-week controlled treatment period. Approximately 94 patients will be assigned to each group. Medication will be taken orally BID for 16 weeks in a double-blinded fashion. At the end of 16 weeks, all patients assigned to CF101 will continue CF101, while patients originally assigned to placebo will be reassigned to CF101. Assessment of peripheral blood mononuclear cell (PBMC) adenosine A3 receptor (A3AR) expression at baseline and during treatment with CF101 in selected sites.
Interventions
DRUGCF101
orally q12h
DRUGPlacebo
orally q12h
Sponsors
Can-Fite BioPharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, 18 to 80 years of age, inclusive * Diagnosis of moderate-to-severe chronic plaque-type psoriasis with body surface area involvement ≥10% * Duration of psoriasis of at least 6 months * Physician global assessment (PGA) ≥3 * Candidate for systemic treatment or phototherapy for psoriasis * Electrocardiogram (ECG) is normal * Females of child-bearing potential must have a negative serum pregnancy test * Females of child-bearing potential must be willing to use 2 methods of contraception * Ability to complete the study in compliance with the protocol * Ability to understand and provide written informed consent.
Exclusion criteria
* Erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis * Treatment with systemic retinoids, corticosteroids, or immunosuppressive agents within 4 weeks of the Baseline visit * Treatment with high potency topical corticosteroids, keratolytics, or coal tar within 2 weeks of the Baseline visit * Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit * Treatment with a biological agent within a period of time equal to 5 times its circulating half-life * Treatment with lithium, hydroxychloroquine or chloroquine within 2 weeks of the Baseline visit * Serum creatinine level greater than 1.5 times the laboratory's upper limit of normal * Liver aminotransferase levels greater than the laboratory's upper limit of normal * Significant acute or chronic medical or psychiatric illness * Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to Screening visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks | 12 weeks | Achievement of PASI 75 indicates a 75% reduction in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Achieving PGA of 0 or 1 | 16 weeks | 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) |
| Numberof Patients Achieving Psoriasis Area and Severity (PASI) Score of 50 or 75 | 16 weeks | 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) |
| Nature and Frequency of Adverse Events | 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 |
Countries
Bulgaria, Israel, Romania, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CF101 2mg Oral tablets given every 12 hours for 16 weeks | 145 |
| Placebo Oral tablets given every 12 hours for 16 weeks | 148 |
| Total | 293 |
Baseline characteristics
| Characteristic | CF101 2mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 48.3 years STANDARD_DEVIATION 13.57 | 50.0 years STANDARD_DEVIATION 13.96 | 49.2 years STANDARD_DEVIATION 13.77 |
| Sex: Female, Male Female | 54 Participants | 53 Participants | 107 Participants |
| Sex: Female, Male Male | 91 Participants | 95 Participants | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 145 | 15 / 148 |
| serious Total, serious adverse events | 0 / 145 | 0 / 148 |
Outcome results
Primary
Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks
Achievement of PASI 75 indicates a 75% reduction in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)
Time frame: 12 weeks
Population: Analysis was performed on the Intent-to-treat (ITT) Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CF101 2 mg | Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks | 12 Participants |
| Placebo | Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks | 10 Participants |
Secondary
Nature and Frequency of Adverse Events
Assessment of safety of CF101 in this patient population by gathering adverse event data based on history, vital signs, physical examination, and laboratory data
Time frame: 32 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CF101 2 mg | Nature and Frequency of Adverse Events | Any | 37 Participants |
| CF101 2 mg | Nature and Frequency of Adverse Events | Gastrointestinal disorders | 8 Participants |
| CF101 2 mg | Nature and Frequency of Adverse Events | Infections and infestations | 10 Participants |
| CF101 2 mg | Nature and Frequency of Adverse Events | Musculoskeletal and connective tissue disorders | 5 Participants |
| CF101 2 mg | Nature and Frequency of Adverse Events | Nervous system disorders | 6 Participants |
| CF101 2 mg | Nature and Frequency of Adverse Events | Renal and urinary disorders | 5 Participants |
| Placebo | Nature and Frequency of Adverse Events | Nervous system disorders | 0 Participants |
| Placebo | Nature and Frequency of Adverse Events | Any | 29 Participants |
| Placebo | Nature and Frequency of Adverse Events | Musculoskeletal and connective tissue disorders | 2 Participants |
| Placebo | Nature and Frequency of Adverse Events | Gastrointestinal disorders | 3 Participants |
| Placebo | Nature and Frequency of Adverse Events | Renal and urinary disorders | 4 Participants |
| Placebo | Nature and Frequency of Adverse Events | Infections and infestations | 13 Participants |
Secondary
Numberof Patients Achieving Psoriasis Area and Severity (PASI) Score of 50 or 75
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)
Time frame: 16 weeks
Population: Analysis performed of the ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CF101 2 mg | Numberof Patients Achieving Psoriasis Area and Severity (PASI) Score of 50 or 75 | 31 participants |
| Placebo | Numberof Patients Achieving Psoriasis Area and Severity (PASI) Score of 50 or 75 | 17 participants |
Secondary
Number of Subjects Achieving PGA of 0 or 1
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)
Time frame: 16 weeks
Population: Analysis was performed on the ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CF101 2 mg | Number of Subjects Achieving PGA of 0 or 1 | 9 participants |
| Placebo | Number of Subjects Achieving PGA of 0 or 1 | 5 participants |