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

NCT ID: NCT03168256

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 528 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-15
• Study Completion Date: 2022-04-27

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

Detailed Description

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.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CF101 2mg

CF101 2mg, orally q12 hours

Group Type: EXPERIMENTAL

CF101 2mg

Intervention Type: DRUG

CF101 tablets, 2mg BID for 16 weeks

CF101 3mg

CF101 3mg, orally q12 hours

Group Type: EXPERIMENTAL

CF101 3mg

Intervention Type: DRUG

CF101 tablets, 3mg BID for 16 weeks

Apremilast 30mg

Apremilast 30mg, orally q12 hours

Group Type: ACTIVE_COMPARATOR

Apremilast 30mg

Intervention Type: DRUG

Apremilast tablets, 30mg BID for 16 weeks

Placebo

Placebo control , orally q12 hours

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Placebo tablets, BID for 16 weeks

Interventions

CF101 2mg

CF101 tablets, 2mg BID for 16 weeks

Intervention Type: DRUG

CF101 3mg

CF101 tablets, 3mg BID for 16 weeks

Intervention Type: DRUG

Apremilast 30mg

Apremilast tablets, 30mg BID for 16 weeks

Intervention Type: DRUG

Placebo Oral Tablet

Placebo tablets, BID for 16 weeks

Intervention Type: DRUG

Other Intervention Names

IB-MECA; IB-MECA; Otezla; Placebo

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Can-Fite BioPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael David, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Clinical Centre of Republika Srpska

Banja Luka, , Bosnia and Herzegovina

University Clinical Centre Mostar

Mostar, , Bosnia and Herzegovina

Clinical Centre of Sarajevo University

Sarajevo, , Bosnia and Herzegovina

"Multiprofile Hospital for Active Treatment - Pazardzhik"

Pazardzhik, , Bulgaria

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

Pernik, , Bulgaria

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

Pleven, , Bulgaria

"Diagnostic-Consultative Aleksandrovska" EOOD

Sofia, , Bulgaria

"Diagnostic-Consultative Centre XX - Sofia" EOOD

Sofia, , Bulgaria

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

Sofia, , Bulgaria

K. Papp Clinical Research

Waterloo, , Canada

Clinical Hospital Center Rijeka

Rijeka, , Croatia

Sestre milosrdnice University Hospital Center

Zagreb, , Croatia

Rambam Medical Center

Haifa, , Israel

Institutul de Cardiologie

Chisinau, , Moldova

Spitalul Clinic Municipal Nr. 3 "Sfanta Treime"

Chisinau, , Moldova

Spitalul Clinic Republican

Chisinau, , Moldova

Centrum Usług Medycznych MaxMed

Bochnia, , Poland

Gdańskim Centrum Zdrowia

Gdansk, , Poland

All-MED Centrum Medyczne

Lodz, , Poland

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

Olsztyn, , Poland

Lubelskie Centrum Diagnostyczne

Świdnik, , Poland

ETG Zamość, ul. Szczebrzeska 11i

Zamość, , Poland

Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL

Brasov, , Romania

SC PELICAN Impex SRL

Oradea, , Romania

Spitalul Clinic Județean de Urgență Sibiu

Sibiu, , Romania

Clinical Centre of Serbia

Belgrade, , Serbia

Clinical Centre Nis

Niš, , Serbia

Military Hospital Nis

Niš, , Serbia

General Hospital Sremska Mitrovica

Sremska Mitrovica, , Serbia

General Hospital Zajecar

Zaječar, , Serbia

Countries

Bosnia and Herzegovina; Bulgaria; Canada; Croatia; Israel; Moldova; Poland; Romania; Serbia

References

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.

Reference Type: DERIVED

PMID: 38279575 (View on PubMed)

Other Identifiers

CF101-301PS

Identifier Type: -

Identifier Source: org_study_id