Trial of CF101 to Treat Patients With Psoriasis
This study is currently recruiting participants.
Verified June 2011 by Can-Fite BioPharma
Sponsor:
Can-Fite BioPharma
Information provided by (Responsible Party):
Can-Fite BioPharma
ClinicalTrials.gov Identifier:
NCT01265667
First received: December 9, 2010
Last updated: April 8, 2013
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Plaque Psoriasis |
Drug: CF101 Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Can-Fite BioPharma:
Primary Outcome Measures:
- Proportion of subjects achieving PASI 75 at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of subjects achieving PGA of 0 or 1 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Proportions of patients achieving Psoriasis Area and Severity (PASI) score of 50 and 75 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Nature and frequency of adverse events [ Time Frame: 32 weeks ] [ Designated as safety issue: Yes ]Assessment of safety of CF101 in this patient population by gathering adverse event data based on history, vital signs, physical examination, and laboratory data
| Estimated Enrollment: | 188 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: CF101 2 mg |
Drug: CF101
orally q12h
Other Name: IB-MECA
|
| Placebo Comparator: Placebo |
Drug: Placebo
orally q12h
Other Name: Dummy pills
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
- PGA ≥3
- Candidate for systemic treatment or phototherapy for psoriasis
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265667
Contacts
| Contact: Sari Fishman, Ph.D. | +972-3-9241114 | sari@canfite.co.il |
Locations
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States | |
| Contact: Mark Lebwohl, Prof. Dr. | |
| Contact: Rachel Karalekas 212-241-3288 Rachel.karalekas@mssm.edu | |
| Sub-Investigator: Madelaine Haddican, Dr. | |
| Bulgaria | |
| UMHAT "G.stranski" | Recruiting |
| Pleven, Bulgaria, 5800, | |
| Contact: Dimitar Gospodinov, Assoc.Prof. | |
| Military Medical Acdemy (MMA) | Recruiting |
| Sofia, Bulgaria, 1606 | |
| Contact: Kadurina, Prof. | |
| City Center for Skin and Venereal Disease | Recruiting |
| Sofia, Bulgaria | |
| Contact: Hitova, Dr. | |
| MHAT "Doverie" | Recruiting |
| Sofia, Bulgaria, 1632, | |
| Contact: Venelinova, Dr. | |
| DCC "Fokus-5"-MIOC, EOOD | Recruiting |
| Sofia,, Bulgaria, 1463 | |
| Contact: Grisha Mateev, Assoc. Prof. | |
| MHAT "Tokuda hospital Sofia" | Recruiting |
| Sofia,, Bulgaria, 1407 | |
| Contact: Zdravka Demerdjieva, Dr. | |
| Multiprofile Hospital for Active Ttreatment | Recruiting |
| Stara Zagora, Bulgaria, 6003 | |
| Contact: Evgeniya Hristakieva, Assoc. Prof. | |
| MHAT Varna at MMA Sofia | Recruiting |
| Varna,, Bulgaria, 9010, | |
| Contact: Iliya Tsingov, Dr. | |
| Israel | |
| Haemek Medical Center | Recruiting |
| Afula, Israel | |
| Contact: Michael Ziv, Dr. 972-4-6494120 ziv_mi@clalit.org.il | |
| Sub-Investigator: Eran Cohen, Dr. | |
| Rambam Medical Center | Recruiting |
| Haifa, Israel, 31096 | |
| Contact: Michal Ramon, MD 972-4-8541668 | |
| Rabin Medical Center | Recruiting |
| Petah Tiqva, Israel, 49100 | |
| Contact: Michael David, Prof. 972-3-9376653 mdavid@clalit.org.il | |
| Sub-Investigator: Lev Pavlovsky, Dr. | |
| Romania | |
| Centrul Medical Euromed | Recruiting |
| Bucuresti, Romania | |
| Contact: Calin Giurcaneanu, Prof.Dr. | |
| Spitalul Clinic Dermato-Venerice | Recruiting |
| Bucuresti, Romania | |
| Contact: Vasile Benea, Prof. Dr. | |
| Emergency County Clinical Hospital | Recruiting |
| Cluj-Napoca, Romania | |
| Contact: Rodica Cosgarea, Prof. Dr. | |
| Spitalul Clinic Judetean de Urgenta Constanta | Recruiting |
| Constanta,, Romania, 900622 | |
| Contact: . Gheorghe Nicola, Prof. Dr. | |
| Spit Clinic Judetean de Urgenta Sf Spiridon Iasi | Recruiting |
| Iasi, Romania, 700368, | |
| Contact: Laura Solovastru, Dr. | |
| County Clinical Emergency Hospital | Recruiting |
| Sibiu, Romania | |
| Contact: Maria Rotaru, Dr. | |
Sponsors and Collaborators
Can-Fite BioPharma
Investigators
| Study Director: | Michael H Silverman, MD | Can-Fite BioPharma |
More Information
Additional Information:
No publications provided
| Responsible Party: | Can-Fite BioPharma |
| ClinicalTrials.gov Identifier: | NCT01265667 History of Changes |
| Other Study ID Numbers: | CF101-202PS |
| Study First Received: | December 9, 2010 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United States: Food and Drug Administration Israel: Ministry of Health Bulgaria: Bulgarian Drug Agency Romania: National Medicines Agency |
Keywords provided by Can-Fite BioPharma:
|
Psoriasis Plaque psoriasis |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013