CF101 Therapy in Patients With Moderate-to-severe Plaque Psoriasis

Study Purpose

This trial will test the hypothesis that the administration of CF101, a novel anti-inflammatory agent, to patients with moderate to severe plaque psoriasis will relieve signs and symptoms of the disease. CF101 effect will be in comparison to apremilast in this study population

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female, 18 to 80 years of age, inclusive; 2. Diagnosis of moderate-to-severe chronic plaque-type psoriasis with BSA involvement ≥10%, as judged by the Investigator; 3. PASI score ≥12 (Appendix 3) 4. Static PGA ≥3 (Appendix 2) 5. Candidate for systemic treatment or phototherapy for psoriasis; 6. Duration of psoriasis of at least 6 months; 7. Elevated whole blood A3AR expression level, defined as ≥ 1.5-fold over a predetermined normal population standard at Screening; 8. Females of child-bearing potential must have a negative serum pregnancy test at screening; 9. 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; 10. Ability to complete the study in compliance with the protocol; and. 11. Ability to understand and provide written informed consent.

Exclusion Criteria:

1. Psoriasis limited to erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis in the absence of plaque psoriasis; 2. Prior treatment with apremilast within 4 weeks prior to the Baseline visit, or contraindication to apremilast; 3. Treatment with systemic retinoids, corticosteroids, tofacitinib, or immunosuppressive agents (e.g., methotrexate, cyclosporine) within 4 weeks of the Baseline visit; 4. Treatment with a biological agent (etanercept, adalimumab, efalizumab, infliximab, ustekinumab, alefacept, secukinumab, or others, including investigational agents) within a period of time equal to 5 times its circulating half-life, or 30 days, whichever is longer, prior to the Baseline visit; 5. Treatment with high potency topical dermatological corticosteroids (Class I-III in US, Class III-IV in Europe), Vitamin D analogs, keratolytics, or coal tar (other than on the scalp, palms, groin, and/or soles) within 2 weeks of the Baseline visit; 6. Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit, or anticipated need for either of these therapies during the study period; 7. Treatment with lithium, hydroxychloroquine or chloroquine within 2 weeks of the Baseline visit, or anticipated need for such drugs during the study period, unless dose has been stable for 3 months prior to the Screening visit and will remain stable throughout the trial; 8. Serum creatinine level greater than 1.5 times the laboratory's upper limit of normal at Screening; 9. Liver aminotransferase levels greater than 1.5 times the laboratory's upper limit of normal at Screening; 10. Electrocardiogram (ECG) at Screening shows abnormalities which, in the judgment of the Investigator, are clinically significant and could, in the judgment of the Principal Investigator, compromise subject safety; 11. Active gastrointestinal disease which could interfere with the absorption of oral medication; 12. Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the Investigator; 13. Active drug or alcohol dependence; 14. History of depression or suicidal ideation within the past year; 15. Concomitant use of strong cytochrome P450 inducers, eg, rifampin, phenobarbital, phenytoin, carbamazepine; 16. Previous participation in a CF101 clinical trial; 17. Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study; 18. Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to the Screening visit.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03168256
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Can-Fite BioPharma
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael David, MD
Principal Investigator Affiliation Rabin Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Israel, Moldova, Republic of, Poland, Romania, Serbia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Additional Details

This is a multicenter, randomized, double-blind, placebo- and active-controlled, study in adult males and females, aged 18 to 80 years, inclusive, with a diagnosis of moderate-to-severe chronic plaque psoriasis. Eligible subjects will be randomly assigned to CF101 2 mg, 3 mg, matching apremilast 30 mg BID, or matching placebo, in a 3:3:3:2 ratio. Blinding will be maintained using a double-dummy technique. Medication will be taken orally BID for 32 weeks in a double-blinded fashion, with the option to continue treatment through an Extension Period to 48 weeks. Subjects initially assigned to the placebo group will be re-randomized at Week 16 to either CF101 2 mg, CF101 3 mg, or apremilast (with appropriate dose titration) in a 1:1:1 ratio and treated through Week 32, while subjects originally assigned to 1 of the active treatment groups will remain on that treatment through Week 32. The primary efficacy endpoint will be assessed at Weeks 16 and 32; at Week 32, all subjects will be offered the opportunity to remain on their assigned blinded drug through Week 48 (ie, the Extension Period of Weeks 33-48). Disease will be assessed using PASI , static PGA , the percentage of BSA involved, and PDI. Subjects will return for assessments and a new supply of study medication at Weeks 4, 8, 12, 16, 20, 24, and 28, and for final study assessments at Week 32. For those subjects continuing into the Extension Period, efficacy and safety assessments will also occur at Weeks 36, 40, 44, and 48. PK will be assessed in a subgroup of approximately 120 subjects at Weeks 0, 8, 16, 24 and 32. PK will be assessed through sparse sampling. Assessment of whole blood A3AR expression levels will occur at Screening, Week 16, and Week 32.

Arms & Interventions

Arms

Experimental: CF101 2mg

CF101 2mg, orally q12 hours

Experimental: CF101 3mg

CF101 3mg, orally q12 hours

Active Comparator: Apremilast 30mg

Apremilast 30mg, orally q12 hours

Placebo Comparator: Placebo

Placebo control , orally q12 hours

Interventions

Drug: - CF101 2mg

CF101 tablets, 2mg BID for 16 weeks

Drug: - CF101 3mg

CF101 tablets, 3mg BID for 16 weeks

Drug: - Apremilast 30mg

Apremilast tablets, 30mg BID for 16 weeks

Drug: - Placebo Oral Tablet

Placebo tablets, BID for 16 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Clinical Centre of Republika Srpska, Banja Luka, Bosnia and Herzegovina

Status

Recruiting

Address

Clinical Centre of Republika Srpska

Banja Luka, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

University Clinical Centre Mostar, Mostar, Bosnia and Herzegovina

Status

Completed

Address

University Clinical Centre Mostar

Mostar, ,

Clinical Centre of Sarajevo University, Sarajevo, Bosnia and Herzegovina

Status

Recruiting

Address

Clinical Centre of Sarajevo University

Sarajevo, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

Pazardzhik, Bulgaria

Status

Recruiting

Address

"Multiprofile Hospital for Active Treatment - Pazardzhik"

Pazardzhik, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

Pernik, Bulgaria

Status

Recruiting

Address

"MHAT"Rahila Angelova"AD, Department of Skin and Venereal Diseases

Pernik, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

Pleven, Bulgaria

Status

Recruiting

Address

"University Multiprofile Hospital for Active Treatment - D-r Georgi Stranski" - EAD, Pleven, Clinic of Skin and Venereal Diseases

Pleven, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

Sofia, Bulgaria

Status

Recruiting

Address

"Diagnostic-Consultative Aleksandrovska" EOOD

Sofia, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

Sofia, Bulgaria

Status

Recruiting

Address

"Diagnostic-Consultative Centre XX - Sofia" EOOD

Sofia, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

Sofia, Bulgaria

Status

Completed

Address

Ambulatory for Specialized Medical Help - Group Practice Dermatology - Clinic EuroDerma" OOD

Sofia, ,

K. Papp Clinical Research, Waterloo, Canada

Status

Completed

Address

K. Papp Clinical Research

Waterloo, ,

Clinical Hospital Center Rijeka, Rijeka, Croatia

Status

Completed

Address

Clinical Hospital Center Rijeka

Rijeka, ,

Zagreb, Croatia

Status

Completed

Address

Sestre milosrdnice University Hospital Center

Zagreb, ,

Rambam Medical Center, Haifa, Israel

Status

Completed

Address

Rambam Medical Center

Haifa, ,

Institutul de Cardiologie, Chisinau, Moldova, Republic of

Status

Recruiting

Address

Institutul de Cardiologie

Chisinau, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

Chisinau, Moldova, Republic of

Status

Recruiting

Address

Spitalul Clinic Municipal Nr. 3 "Sfanta Treime"

Chisinau, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

Spitalul Clinic Republican, Chisinau, Moldova, Republic of

Status

Recruiting

Address

Spitalul Clinic Republican

Chisinau, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

Centrum Usług Medycznych MaxMed, Bochnia, Poland

Status

Recruiting

Address

Centrum Usług Medycznych MaxMed

Bochnia, ,

Site Contact

Małgorzata Kalicka-Dudzik, MD

[email protected]

502 797 488

Gdańskim Centrum Zdrowia, Gdańsk, Poland

Status

Recruiting

Address

Gdańskim Centrum Zdrowia

Gdańsk, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

Olsztyn, Poland

Status

Recruiting

Address

Miejski Szpital Zespolony Klinika Dermatologii Chorób Przenoszonych Drogą Płciową i Immunologii klinicznej

Olsztyn, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

ETG Zamość, ul. Szczebrzeska 11i, Zamość, Poland

Status

Recruiting

Address

ETG Zamość, ul. Szczebrzeska 11i

Zamość, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

All-MED Centrum Medyczne, Łódź, Poland

Status

Recruiting

Address

All-MED Centrum Medyczne

Łódź, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

Lubelskie Centrum Diagnostyczne, Świdnik, Poland

Status

Recruiting

Address

Lubelskie Centrum Diagnostyczne

Świdnik, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

Braşov, Romania

Status

Recruiting

Address

Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL

Braşov, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

SC PELICAN Impex SRL, Oradea, Romania

Status

Recruiting

Address

SC PELICAN Impex SRL

Oradea, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

Sibiu, Romania

Status

Recruiting

Address

Spitalul Clinic Județean de Urgență Sibiu

Sibiu, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

Clinical Centre of Serbia, Belgrade, Serbia

Status

Completed

Address

Clinical Centre of Serbia

Belgrade, ,

Clinical Centre Nis, Niš, Serbia

Status

Recruiting

Address

Clinical Centre Nis

Niš, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

Military Hospital Nis, Niš, Serbia

Status

Recruiting

Address

Military Hospital Nis

Niš, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

General Hospital Sremska Mitrovica, Sremska Mitrovica, Serbia

Status

Recruiting

Address

General Hospital Sremska Mitrovica

Sremska Mitrovica, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

General Hospital Zajecar, Zaječar, Serbia

Status

Recruiting

Address

General Hospital Zajecar

Zaječar, ,

Site Contact

Study Coordinator

[email protected]

972-3-9241114

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