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Plaque PsoriasisPhase 2NCT00428974

Safety and Efficacy Study of CF101 to Treat Psoriasis

A Phase 2 study testing CF101 1mg, CF101 2mg and CF101 4mg in people with Plaque Psoriasis, run by Can-Fite BioPharma at 4 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will test the hypothesis that CF101, which is under development to treat other immune-mediated inflammatory diseases, will provide clinical benefits in the treatment of chronic plaque psoriasis. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
CF101 1mg, CF101 2mg and CF101 4mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
4 sitesIsrael
Study dates
Jun 2007to Sep 2009
Phase
Phase 2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, 18 to 70 years of age, inclusive;
  • Diagnosis of moderate-to-severe chronic plaque-type psoriasis with body surface area involvement ≥10%, as judged by the Investigator;
  • Duration of psoriasis of at least 6 months;
  • PASI score ≥10;
  • Body weight ≤100 kg;
  • Candidate for systemic treatment or phototherapy for psoriasis;
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  • ECG is normal or shows abnormalities which, in the judgment of the Investigator, are not clinically significant;
  • Females of child-bearing potential must have a negative serum pregnancy test at screening;
  • Females of child-bearing potential must be willing to use 2 methods of contraception deemed adequate by the Investigator (for example oral contraceptive pills plus a barrier method) to be eligible for, and continue participation in, the study;
  • Ability to complete the study in compliance with the protocol; and
  • 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 immunosuppressants (e.g., methotrexate, cyclosporine) within 6 weeks of the Baseline visit;
  • Treatment with high potency topical corticosteroids (Class I-III), keratolytics, or coal tar (other than on the scalp, palms, groin, and/or soles) within 2 weeks of the Baseline visit;
  • Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit, or anticipated need for either of these therapies during the study period;
  • Treatment with a biological agent (including etanercept, adalimumab, efalizumab, infliximab, or alefacept) within a period of time equal to 5 times its circulating half-life, or 30 days, whichever is longer, prior to the Baseline visit;
  • History of poor clinical response to methotrexate after an adequate regimen and duration of treatment;
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  • Treatment with systemic nonsteroidal anti-inflammatory drugs, beta-blockers, lithium, hydroxychloroquine, chloroquine, or systemic terbinafine within 2 weeks of the Baseline visit, or anticipated need for such drugs during the study period;
  • Presence or history of uncontrolled asthma;
  • Presence or history of uncontrolled arterial hypertension or symptomatic hypotension;
  • Significant cardiac arrhythmia or conduction block, congestive heart failure (New York Heart Association Class 3-4), or any other evidence of clinically significant heart disease or clinically significant findings on screening electrocardiogram;
  • Hemoglobin level <9.0 gm/L;
  • Platelet count <125,000/mm^3;
  • White blood cell count <3500/mm^3;
  • Serum creatinine level greater than 1.5 times the laboratory's upper limit of normal;
  • Liver aminotransferase levels greater than 2 times the laboratory's upper limit of normal;
  • Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the Investigator;
  • History of malignancy within the past 5 years (excluding basal cell carcinoma of the skin and ≤3 cutaneous squamous cell carcinomas, all of which have been completely excised);
  • Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study;
  • Participation in another investigational drug or vaccine trial concurrently or within 30 days; or within 5 half lives of a biological investigational product, whichever is longer;
  • Other conditions which would confound the study evaluations or endanger the safety of the patient.

Trial locations and contacts

4 sites in 1 country.

Israel4 sites

  • Haemek Medical Center

    Afula

  • Wolfson Medical Center

    Holon

  • Rabin Medical Center

    Petah Tikva

  • Sheba Medical Center

    Tel HaShomer

Other trials in Israel

About this study

Official title: A Phase 2, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study of the Safety and Activity of Daily CF101 Administered Orally in Patients With Moderate-to-Severe Plaque Psoriasis

This study will test the hypothesis that CF101, which is under development to treat other immune-mediated inflammatory diseases, will provide clinical benefits in the treatment of chronic plaque psoriasis. Patients with psoriasis who qualify for the study will be treated every 12 hours (q12h) with CF101 capsules, or placebo capsules, for 12 weeks. The safety of treatment will be carefully assessed through clinical and laboratory monitoring. The effect of treatment on psoriasis will be evaluated through standard techniques of examination and measurement of the severity of skin involvement.

Read the detailed description

This is a Phase 2, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study in adult males and females, ages 18 to 70 years, inclusive, with a diagnosis of moderate-to-severe chronic plaque psoriasis. At the Screening Visit, patients who provide written informed consent will have screening procedures performed, including a complete medical history, medication history, physical examination, including height, weight, blood pressure, pulse rate and temperature, and clinical laboratory tests.

Eligible patients will be those who have not received systemic retinoids, corticosteroids, or immunosuppressants (e.g., methotrexate, cyclosporine) within 6 weeks prior to initiation of study; or high potency topical corticosteroids (Class I-III), keratolytics, or coal tar (other than on the scalp, palms, groin, and/or soles); and UV or Dead Sea therapy within 4 weeks prior to initiation of study treatment. Eligible patients will be sequentially assigned to 1 of 3 dosing cohorts:

Cohort 1: CF101 1 mg (15 patients) or Placebo (5 patients); Cohort 2: CF101 2 mg (15 patients) or Placebo (5 patients); Cohort 3: CF101 4 mg (15 patients) or Placebo (5 patients).

Medication will be taken orally q12h for 12 weeks. Disease activity will be assessed using the Psoriasis Area and Severity Index (PASI) and the Physician Global Assessment (PGA). Patients will return for assessments at Weeks 2, 4, 8, 12 and 14.

Being tested
CF101 1mg, CF101 2mg, CF101 4mg, Placebo
Keywords
Psoriasis
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CF101 1mgDrug

    Also called IB-MECA

    CF101 1 mg q12 hours for 12 weeks

  • CF101 2mgDrug

    Also called IB-MECA

    CF101 2 mg q12 hours for 12 weeks

  • CF101 4mgDrug

    Also called IB-MECA

    CF101 4 mg q12 hours for 12 weeks

  • PlaceboDrug

    Also called Inactive pill

    Placebo tablets q12 hours for 12 weeks

Study groups in NCT00428974
Study groupRoleWhat they receive
CF101 1 mgExperimentalNot described
Receives: Drug: CF101 1mg
CF101 2mgExperimentalNot described
Receives: Drug: CF101 2mg
CF101 4mgExperimentalNot described
Receives: Drug: CF101 4mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline (CFB) in Psoriasis Area and Severity Index (PASI) Score

    PASI scale is sum of redness, thickness, and scale scores, ranging from 0 (no disease) to 72 (most severe possible score); lower scores, i..e., negative change from baseline, indicate improvement

    Measured: 12 weeks minus baseline

Secondary outcomes (1)

  1. The Number of Patients Who Achieve a Score of "Almost Clear" or "Clear" by Physician's Global Assessment (PGA)

    PGA is a scale from 0 (clear, no disease) to 5 (most severe score); patients who improve to 0 (clear) or 1 (minimal disease) are tabulated in this outcome

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionSep 2009
  4. Study completionSep 2009

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00428974
Sponsor's protocol ID
CF101-201PS
Status last verified
Feb 2023
First submitted
29 Jan 2007
Last updated
8 Feb 2023
Data monitoring committee
No

Publications

  • David M, Akerman L, Ziv M, Kadurina M, Gospodinov D, Pavlotsky F, Yankova R, Kouzeva V, Ramon M, Silverman MH, Fishman P. Treatment of plaque-type psoriasis with oral CF101: data from an exploratory randomized phase 2 clinical trial. J Eur Acad Dermatol Venereol. 2012 Mar;26(3):361-7. doi: 10.1111/j.1468-3083.2011.04078.x. Epub 2011 Apr 20.

    PubMed 21504485

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CF101 1mg, CF101 2mg and CF101 4mg in people with Plaque Psoriasis, run by Can-Fite BioPharma at 4 sites in Israel.

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 11 inclusion and 20 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Israel. 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 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.

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 26 Sep 2011). 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?

Change From Baseline (CFB) in Psoriasis Area and Severity Index (PASI) Score (time frame: 12 weeks minus baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00428974, which also lists 1 linked publication.

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 8 Feb 2023.

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