Plaque PsoriasisPhase 2/3NCT01265667
Trial of CF101 to Treat Patients With Psoriasis
A Phase 2/3 study testing CF101 in people with Plaque Psoriasis, run by Can-Fite BioPharma at 18 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- CF101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 293 participants
- Where
- 18 sitesin 4 countries
- Study dates
- Jul 2011to May 2015
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
Bulgaria8 sites
UMHAT "G.stranski"
Pleven, 5800,
MHAT "Tokuda hospital Sofia"
Sofia, 1407
DCC "Fokus-5"-MIOC, EOOD
Sofia, 1463
Military Medical Acdemy (MMA)
Sofia, 1606
MHAT "Doverie"
Sofia, 1632,
City Center for Skin and Venereal Disease
Sofia
Multiprofile Hospital for Active Ttreatment
Stara Zagora, 6003
MHAT Varna at MMA Sofia
Varna, 9010,
Romania6 sites
Centrul Medical Euromed
Bucharest
Spitalul Clinic Dermato-Venerice
Bucharest
Emergency County Clinical Hospital
Cluj-Napoca
Spitalul Clinic Judetean de Urgenta Constanta
Constanța, 900622
Spit Clinic Judetean de Urgenta Sf Spiridon Iasi
Iași, 700368,
County Clinical Emergency Hospital
Sibiu
Israel3 sites
Haemek Medical Center
Afula
Rambam Medical Center
Haifa, 31096
Rabin Medical Center
Petah Tikva, 49100
About this study
Official title: A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of the Efficacy and Safety of Daily CF101 Administered Orally in Patients With Moderate-to-Severe Plaque Psoriasis
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.
Read the 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.
- Conditions
- Plaque Psoriasis
- Being tested
- CF101, Placebo
- Keywords
- Psoriasis, Plaque psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CF101Drug
Also called IB-MECA
orally q12h
PlaceboDrug
Also called Dummy pills
orally q12h
| Study group | Role | What they receive |
|---|---|---|
| CF101 2 mg | Experimental | CF101 2mg oral tablets Receives: Drug: CF101 |
| Placebo | Placebo comparator | Placebo oral tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (3)
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)
Measured: 16 weeks
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)
Measured: 16 weeks
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
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startJul 2011
- Primary completionMar 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can-Fite BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael H Silverman, MD, Study director, Can-Fite BioPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265667
- Sponsor's protocol ID
- CF101-202PS
- Status last verified
- Oct 2020
- First submitted
- 9 Dec 2010
- Last updated
- 18 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of the Efficacy and Safety of Daily CF101 Administered Orally in Patients With Moderate-to-Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01265667
- Acronym / sponsor ID
- CF101-202PS
- Conditions
- Plaque Psoriasis
- Keywords
- Psoriasis, Plaque psoriasis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Can-Fite BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Dec 2010 (estimated)
- Results
- Posted 20 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CF101 2 mg | Experimental | Drug: CF101CF101 2mg oral tablets |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oral tablets |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CF101Also: IB-MECAorally q12h | Drug | CF101 2 mg |
| PlaceboAlso: Dummy pillsorally q12h | Drug | Placebo |
Primary outcome
Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks
Time frame: 12 weeks
Achievement of PASI 75 indicates a 75% reduction in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)
3 secondary outcomes
Number of Subjects Achieving PGA of 0 or 1
Time frame: 16 weeks
Numberof Patients Achieving Psoriasis Area and Severity (PASI) Score of 50 or 75
Time frame: 16 weeks
Nature and Frequency of Adverse Events
Time frame: 32 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Can-Fite BioPharma websiteLink provided by the sponsor.
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A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
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A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Silverman, MD study director
Can-Fite BioPharma
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CF101 in people with Plaque Psoriasis, run by Can-Fite BioPharma at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Bulgaria, Romania, Israel, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.