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

NCT03168256 | Completed Phase 3 FDA Drug

• 1 other identifier: CF101-301PS
• Study Type: interventional
• Target: 528
• Locations: 9 countries
• Sites: 30

Brief Summary

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75) at Week 16

  Evaluate the efficacy of oral CF101 2 mg or 3 mg twice daily (BID) in patients with moderate-to-severe plaque psoriasis, compared with placebo, as determined by the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75) at Week 16 (superiority)

  16 weeks

• Adverse event profile in this patient popluation

  Nature, incidence and severity of treatment-emergent adverse events

  16 weeks

Secondary Outcomes (15)

• Psoriasis Area and Severity Index (PASI) score response of ≥50% (PASI 50) at Week 16

  16 weeks

• Physician Global Assessment (PGA)

  16 weeks

• Psoriasis Disability Index (PDI)

  16 weeks

• CF101 PASI 75 compare to apremilast

  weeks 16-32

• CF101 PGA score compare to apremilast

  weeks 16-32

Study Arms (4)

CF101 2mg

EXPERIMENTAL

CF101 2mg, orally q12 hours

Drug: CF101 2mg

CF101 3mg

EXPERIMENTAL

CF101 3mg, orally q12 hours

Drug: CF101 3mg

Apremilast 30mg

ACTIVE COMPARATOR

Apremilast 30mg, orally q12 hours

Drug: Apremilast 30mg

Placebo

PLACEBO COMPARATOR

Placebo control , orally q12 hours

Drug: Placebo Oral Tablet

Interventions

CF101 2mg DRUG

CF101 tablets, 2mg BID for 16 weeks

Also known as: IB-MECA

CF101 2mg

CF101 3mg DRUG

CF101 tablets, 3mg BID for 16 weeks

Also known as: IB-MECA

CF101 3mg

Apremilast 30mg DRUG

Apremilast tablets, 30mg BID for 16 weeks

Also known as: Otezla

Apremilast 30mg

Placebo Oral Tablet DRUG

Placebo tablets, BID for 16 weeks

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 to 80 years of age, inclusive;
• Diagnosis of moderate-to-severe chronic plaque-type psoriasis with BSA involvement ≥10%, as judged by the Investigator;
• PASI score ≥12 (Appendix 3)
• Static PGA ≥3 (Appendix 2)
• Candidate for systemic treatment or phototherapy for psoriasis;
• Duration of psoriasis of at least 6 months;
• Elevated whole blood A3AR expression level, defined as ≥ 1.5-fold over a predetermined normal population standard at Screening;
• 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.

You may not qualify if:

• Psoriasis limited to erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis in the absence of plaque psoriasis;
• Prior treatment with apremilast within 4 weeks prior to the Baseline visit, or contraindication to apremilast;
• Treatment with systemic retinoids, corticosteroids, tofacitinib, or immunosuppressive agents (e.g., methotrexate, cyclosporine) within 4 weeks of the Baseline visit;
• 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;
• 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;
• 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 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;
• Serum creatinine level greater than 1.5 times the laboratory's upper limit of normal at Screening;
• Liver aminotransferase levels greater than 1.5 times the laboratory's upper limit of normal at Screening;
• 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;
• Active gastrointestinal disease which could interfere with the absorption of oral medication;
• Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the Investigator;
• Active drug or alcohol dependence;
• History of depression or suicidal ideation within the past year;
• Concomitant use of strong cytochrome P450 inducers, eg, rifampin, phenobarbital, phenytoin, carbamazepine;

Sponsors & Collaborators

• Can-Fite BioPharma: lead

Study Sites (30)

Clinical Centre of Republika Srpska

Banja Luka, Bosnia and Herzegovina

Location

University Clinical Centre Mostar

Mostar, Bosnia and Herzegovina

Location

Clinical Centre of Sarajevo University

Sarajevo, Bosnia and Herzegovina

Location

"Multiprofile Hospital for Active Treatment - Pazardzhik"

Pazardzhik, Bulgaria

Location

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

Pernik, Bulgaria

Location

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

Pleven, Bulgaria

Location

"Diagnostic-Consultative Aleksandrovska" EOOD

Sofia, Bulgaria

Location

"Diagnostic-Consultative Centre XX - Sofia" EOOD

Sofia, Bulgaria

Location

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

Sofia, Bulgaria

Location

K. Papp Clinical Research

Waterloo, Canada

Location

Clinical Hospital Center Rijeka

Rijeka, Croatia

Location

Sestre milosrdnice University Hospital Center

Zagreb, Croatia

Location

Rambam Medical Center

Haifa, Israel

Location

Institutul de Cardiologie

Chisinau, Moldova

Location

Spitalul Clinic Municipal Nr. 3 "Sfanta Treime"

Chisinau, Moldova

Location

Spitalul Clinic Republican

Chisinau, Moldova

Location

Centrum Usług Medycznych MaxMed

Bochnia, Poland

Location

Gdańskim Centrum Zdrowia

Gdansk, Poland

Location

All-MED Centrum Medyczne

Lodz, Poland

Location

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

Olsztyn, Poland

Location

Lubelskie Centrum Diagnostyczne

Świdnik, Poland

Location

ETG Zamość, ul. Szczebrzeska 11i

Zamość, Poland

Location

Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL

Brasov, Romania

Location

SC PELICAN Impex SRL

Oradea, Romania

Location

Spitalul Clinic Județean de Urgență Sibiu

Sibiu, Romania

Location

Clinical Centre of Serbia

Belgrade, Serbia

Location

Clinical Centre Nis

Niš, Serbia

Location

Military Hospital Nis

Niš, Serbia

Location

General Hospital Sremska Mitrovica

Sremska Mitrovica, Serbia

Location

General Hospital Zajecar

Zaječar, Serbia

Location

Related Publications (1)

• Papp KA, Beyska-Rizova S, Gantcheva ML, Slavcheva Simeonova E, Brezoev P, Celic M, Groppa L, Blicharski T, Selmanagic A, Kalicka-Dudzik M, Calin CA, Trailovic N, Ramon M, Bareket-Samish A, Harpaz Z, Farbstein M, Silverman MH, Fishman P; COMFORT-1 Study Investigators. Efficacy and safety of piclidenoson in plaque psoriasis: Results from a randomized phase 3 clinical trial (COMFORT-1). J Eur Acad Dermatol Venereol. 2024 Jun;38(6):1112-1120. doi: 10.1111/jdv.19811. Epub 2024 Jan 26.

  PMID: 38279575 DERIVED

MeSH Terms

Interventions

CF101; N(6)-(3-iodobenzyl)-5'-N-methylcarboxamidoadenosine; apremilast

Study Officials

• Michael David, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: September 15, 2018
• Primary Completion: January 6, 2022
• Study Completion: April 27, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

CR (2); BU (6); MO (3); PL (6); CA (1); BO (3); IL (1); RO (3); SE (5)