- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00428974
Safety and Efficacy Study of CF101 to Treat Psoriasis
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Afula, Israel
- HaEmek Medical Center
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Holon, Israel
- Wolfson Medical Center
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Petach Tikva, Israel
- Rabin Medical Center
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Tel-Hashomer, Israel
- Sheba Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
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Placebo tablets q12 hours for 12 weeks
Other Names:
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EXPERIMENTAL: CF101 1 mg
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CF101 1 mg q12 hours for 12 weeks
Other Names:
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EXPERIMENTAL: CF101 2mg
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CF101 2 mg q12 hours for 12 weeks
Other Names:
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EXPERIMENTAL: CF101 4mg
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CF101 4 mg q12 hours for 12 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline (CFB) in Psoriasis Area and Severity Index (PASI) Score
Time Frame: 12 weeks minus baseline
|
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
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12 weeks minus baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number of Patients Who Achieve a Score of "Almost Clear" or "Clear" by Physician's Global Assessment (PGA)
Time Frame: 12 weeks
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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
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12 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CF101-201PS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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