Plaque PsoriasisPhase 3NCT03168256
CF101 Therapy in Patients With Moderate-to-severe Plaque Psoriasis
A Phase 3 study testing CF101 2mg, CF101 3mg and Apremilast 30mg in people with Plaque Psoriasis, run by Can-Fite BioPharma at 30 sites in 9 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- CF101 2mg, CF101 3mg and Apremilast 30mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 528 participants
- Where
- 30 sitesin 9 countries
- Study dates
- 15 Sep 2018to 27 Apr 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
Show all 18Show fewer
- 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;
- Previous participation in a CF101 clinical trial;
- 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;
- Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to the Screening visit.
Trial locations and contacts
30 sites in 9 countries.
30 sites in 9 countries
Bulgaria6 sites
"Multiprofile Hospital for Active Treatment - Pazardzhik"
Pazardzhik
"MHAT"Rahila Angelova"AD, Department of Skin and Venereal Diseases
Pernik
"University Multiprofile Hospital for Active Treatment - D-r Georgi Stranski" - EAD, Pleven, Clinic of Skin and Venereal Diseases
Pleven
"Diagnostic-Consultative Aleksandrovska" EOOD
Sofia
"Diagnostic-Consultative Centre XX - Sofia" EOOD
Sofia
Ambulatory for Specialized Medical Help - Group Practice Dermatology - Clinic EuroDerma" OOD
Sofia
Poland6 sites
Centrum Usług Medycznych MaxMed
Bochnia
Gdańskim Centrum Zdrowia
Gdansk
All-MED Centrum Medyczne
Lodz
Miejski Szpital Zespolony Klinika Dermatologii Chorób Przenoszonych Drogą Płciową i Immunologii klinicznej
Olsztyn
Lubelskie Centrum Diagnostyczne
Świdnik
ETG Zamość, ul. Szczebrzeska 11i
Zamość
Serbia5 sites
Clinical Centre of Serbia
Belgrade
Clinical Centre Nis
Niš
Military Hospital Nis
Niš
General Hospital Sremska Mitrovica
Sremska Mitrovica
General Hospital Zajecar
Zaječar
Bosnia and Herzegovina3 sites
Clinical Centre of Republika Srpska
Banja Luka
University Clinical Centre Mostar
Mostar
Clinical Centre of Sarajevo University
Sarajevo
Moldova3 sites
Institutul de Cardiologie
Chisinau
Spitalul Clinic Municipal Nr. 3 "Sfanta Treime"
Chisinau
Spitalul Clinic Republican
Chisinau
Romania3 sites
Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
Brasov
SC PELICAN Impex SRL
Oradea
Spitalul Clinic Județean de Urgență Sibiu
Sibiu
Croatia2 sites
Clinical Hospital Center Rijeka
Rijeka
Sestre milosrdnice University Hospital Center
Zagreb
About this study
Official title: A Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled Study of the Efficacy and Safety of Daily CF101 Administered Orally in Patients With Moderate-to-Severe Plaque Psoriasis
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
Read the 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
- Being tested
- CF101 2mg, CF101 3mg, Apremilast 30mg, Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CF101 2mgDrug
Also called IB-MECA
CF101 tablets, 2mg BID for 16 weeks
CF101 3mgDrug
Also called IB-MECA
CF101 tablets, 3mg BID for 16 weeks
Apremilast 30mgDrug
Also called Otezla
Apremilast tablets, 30mg BID for 16 weeks
Placebo Oral TabletDrug
Also called Placebo
Placebo tablets, BID for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| CF101 2mg | Experimental | CF101 2mg, orally q12 hours Receives: Drug: CF101 2mg |
| CF101 3mg | Experimental | CF101 3mg, orally q12 hours Receives: Drug: CF101 3mg |
| Apremilast 30mg | Active comparator | Apremilast 30mg, orally q12 hours Receives: Drug: Apremilast 30mg |
| Placebo | Placebo comparator | Placebo control , orally q12 hours Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 16 weeks
Adverse event profile in this patient popluation
Nature, incidence and severity of treatment-emergent adverse events
Measured: 16 weeks
Secondary outcomes (15)
Psoriasis Area and Severity Index (PASI) score response of ≥50% (PASI 50) at Week 16
Evaluate the efficacy of oral piclidenoson 2 mg or 3 mg BID, compared with placebo, as determined by the proportion of subjects who achieve PASI 50 at Week 16 (superiority);
Measured: 16 weeks
Physician Global Assessment (PGA)
Evaluate the efficacy of oral piclidenoson 2 mg or 3 mg BID, compared with placebo, as determined by the proportion of subjects who achieve PGA score of 0 or 1 at Week 16;
Measured: 16 weeks
Psoriasis Disability Index (PDI)
Evaluate the efficacy of oral piclidenoson 2 mg or 3 mg BID, compared with placebo, as determined by the proportion of subjects who achieve improvement on the PDI at Week 16;
Measured: 16 weeks
CF101 PASI 75 compare to apremilast
Evaluate the efficacy of oral piclidenoson 2 mg or 3 mg BID, compared with apremilast, as determined by the proportion of subjects who achieve PASI 75 at Weeks 16 and 32;
Measured: weeks 16-32
CF101 PGA score compare to apremilast
Evaluate the efficacy of oral piclidenoson 2 mg or 3 mg BID, compared with apremilast, as determined by the proportion of subjects who achieve PGA score of 0 or 1, at Weeks 16 and 32;
Measured: weeks 16-32
CF101 PASI 50 compare to apremilast
Evaluate the efficacy of oral piclidenoson 2 mg or 3 mg BID, compared with apremilast, as determined by the proportion of subjects who achieve PASI 50 at Weeks 16 and 32;
Measured: weeks 16-32
CF101 PDI improvement compare to apremilast
Evaluate the efficacy of oral piclidenoson 2 mg or 3 mg BID, compared with apremilast, as determined by the proportion of subjects who achieve an improvement in PDI at Weeks 16 and 32;
Measured: weeks 16-32
Apremilast PASI 75 compare to placebo
Establish assay sensitivity within this trial by comparing the efficacy of apremilast 30 mg BID with that of placebo tablets BID, as determined by the proportion of subjects who achieve PASI 75, PGA score of 0 or 1, PASI 50, and improvement in PDI at Week 16 (superiority);
Measured: weeks 16-32
Apremilast PGA compare to placebo
Establish assay sensitivity within this trial by comparing the efficacy of apremilast 30 mg BID with that of placebo tablets BID, as determined by the proportion of subjects who achieve PGA score of 0 or 1 at Week 16;
Measured: weeks 16-32
Apremilast PASI 50 compare to placebo
Establish assay sensitivity within this trial by comparing the efficacy of apremilast 30 mg BID with that of placebo tablets BID, as determined by the proportion of subjects who achieve PASI 50 at Week 16;
Measured: weeks 16-32
Apremilast PDI compare to placebo
Establish assay sensitivity within this trial by comparing the efficacy of apremilast 30 mg BID with that of placebo tablets BID, as determined by the proportion of subjects who achieve improvement in PDI at Week 16;
Measured: 16 weeks
Adverse event profile of piclidenoson through the Extension Period of up to 48 weeks of treatment
Nature, incidence, and severity of treatment-emergent adverse events
Measured: 48 weeks
Efficacy of piclidenoson, as determined by changes in PASI score, through the Extension Period of up to 48 weeks of treatment
The proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75) at Week 48
Measured: 48 weeks
Determine pharmacokinetics (PK) of piclidenoson under the circumstances of this trial using sparse sampling
Serum concentration of piclidenoson
Measured: 48 weeks
Evaluate the relationship between pre-treatment whole blood A3 adenosine receptor (A3AR) expression levels and response to piclidenoson treatment.
Explore the relationship between white blood cell (WBC) adenosine A3 receptor (A3AR) expression and treatment response, by taking WBC sample at baseline
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start15 Sep 2018
- Primary completion6 Jan 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 528 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can-Fite BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael David, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168256
- Sponsor's protocol ID
- CF101-301PS
- Status last verified
- Jun 2022
- First submitted
- 24 May 2017
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 38279575
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled Study of the Efficacy and Safety of Daily CF101 Administered Orally in Patients With Moderate-to-Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03168256
- Acronym / sponsor ID
- CF101-301PS
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- Can-Fite BioPharmaIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CF101 2mg | Experimental | Drug: CF101 2mgCF101 2mg, orally q12 hours |
| CF101 3mg | Experimental | Drug: CF101 3mgCF101 3mg, orally q12 hours |
| Apremilast 30mg | Active comparator | Drug: Apremilast 30mgApremilast 30mg, orally q12 hours |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPlacebo control , orally q12 hours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CF101 2mgAlso: IB-MECACF101 tablets, 2mg BID for 16 weeks | Drug | CF101 2mg |
| CF101 3mgAlso: IB-MECACF101 tablets, 3mg BID for 16 weeks | Drug | CF101 3mg |
| Apremilast 30mgAlso: OtezlaApremilast tablets, 30mg BID for 16 weeks | Drug | Apremilast 30mg |
| Placebo Oral TabletAlso: PlaceboPlacebo tablets, BID for 16 weeks | Drug | Placebo |
Primary outcome
Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75) at Week 16
Time frame: 16 weeks
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)
Adverse event profile in this patient popluation
Time frame: 16 weeks
Nature, incidence and severity of treatment-emergent adverse events
15 secondary outcomes
Psoriasis Area and Severity Index (PASI) score response of ≥50% (PASI 50) at Week 16
Time frame: 16 weeks
Physician Global Assessment (PGA)
Time frame: 16 weeks
Psoriasis Disability Index (PDI)
Time frame: 16 weeks
CF101 PASI 75 compare to apremilast
Time frame: weeks 16-32
CF101 PGA score compare to apremilast
Time frame: weeks 16-32
CF101 PASI 50 compare to apremilast
Time frame: weeks 16-32
CF101 PDI improvement compare to apremilast
Time frame: weeks 16-32
Apremilast PASI 75 compare to placebo
Time frame: weeks 16-32
Apremilast PGA compare to placebo
Time frame: weeks 16-32
Apremilast PASI 50 compare to placebo
Time frame: weeks 16-32
Apremilast PDI compare to placebo
Time frame: 16 weeks
Adverse event profile of piclidenoson through the Extension Period of up to 48 weeks of treatment
Time frame: 48 weeks
Efficacy of piclidenoson, as determined by changes in PASI score, through the Extension Period of up to 48 weeks of treatment
Time frame: 48 weeks
Determine pharmacokinetics (PK) of piclidenoson under the circumstances of this trial using sparse sampling
Time frame: 48 weeks
Evaluate the relationship between pre-treatment whole blood A3 adenosine receptor (A3AR) expression levels and response to piclidenoson treatment.
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Derived from this study: PubMed 38279575Papp 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael David, MD principal investigator
Rabin Medical Center
30 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CF101 2mg, CF101 3mg and Apremilast 30mg in people with Plaque Psoriasis, run by Can-Fite BioPharma at 30 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Bulgaria, Poland, Serbia, Bosnia and Herzegovina, Moldova and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75) at Week 16 (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03168256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.