PsoriasisPhase 1NCT05642182
Study of SFA002 in Patients with Mild to Moderate Psoriasis Plaques
A Phase 1 study testing SFA002 in people with Psoriasis, run by SFA Therapeutics at 3 sites in United States.
Trial summary
The purpose of this study is to determine the safety, metabolism and potential effect of drug product SFA-002 on mild moderate and severe chronic plaque psoriasis. Psoriasis is a common chronic skin disorder that affects over 4 million people. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- SFA002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Mar 2022to 31 Jul 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects of both sexes ≥18 years of age with at least one skin plaque that is >5 cm2 due to known psoriasis considered clinically to be MILD to MODERATE or MODERATE to SEVERE during evaluation and diagnosis at least 1 year prior. Mild is defined as "Just detectable to mild thickening; pink to light red coloration; predominantly fine scaling", whereas moderate is defined as "Clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling".
- Have or have not been treated with phototherapy, systemic therapy, or other therapies for their psoriasis
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use effective contraceptive methods (such as abstinence, intrauterine device (IUD), or double barrier device) during the study and for at least 3 months following completion of the study.
- Mentally competent, able to understand and willingness to sign the Informed Consent Form (ICF).
- Able to undergo the investigations and to follow the visit schedule stated in the study protocol.
Who cannot join
- The forms of psoriasis other than chronic plaque psoriasis (such as drug-induced psoriasis or guttate, erythrodermic, or pustular psoriasis) or if the psoriasis does not meet the criterion of chronicity (defined as a clinically significant flare of psoriasis within 12 weeks before baseline).
- Presence of other form of inflammatory skin diseases (such as atopic dermatitis) or infectious diseases (such as cellulitis, warts, fungal cutaneous diseases, etc.)
- A clinically significant flare of psoriasis within 12 weeks before baseline. (Note: The determination of whether prospective study participants had a "significant flare" prior to study baseline is left to the investigators. The intent of this criterion was to ensure the condition is sufficiently stable and aligned with the chronic nature of plaque psoriasis, so that an adequate assessment of the efficacy could be made.)
- Prior or current use of psoriasis medications that might confound assessment of efficacy of the investigational supplements used in this study, unless there were used before their washout period prior to study initiation (see Table 2 for specific medications and their washout periods).
- Known serious medical illness, such as significant cardiac disease (e.g., symptomatic congestive heart failure, unstable angina pectoris, symptomatic coronary artery disease, myocardial infarction within the past 6 months, uncontrolled or symptomatic cardiac arrhythmia, or New York Heart Association Class III or IV), or severe debilitating pulmonary disease, that would potentially increase subjects' risk for toxicity.
- Known to have a history of risk factors for torsade de pointes (e.g., clinically significant heart failure, hypokalemia, family history of Long QT Syndrome).
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- Known to have arterial thrombotic event, stroke, or transient ischemia attack within the past 12 months.
- Known to have uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure >90 mm Hg), or peripheral vascular disease ≥grade 2.
- Known to have active central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.
- Any active uncontrolled bleeding, a bleeding diathesis (e.g., active peptic ulcer disease), or a history of bleeding (e.g., hemoptysis, upper or lower gastrointestinal [GI] bleeding) within the past 6 months.
- Dyspnea with minimal to moderate exertion; large and recurrent pleural or peritoneal effusions requiring frequent drainage (e.g. weekly); or any amount of clinically significant pericardial effusion.
- Diabetes of any type, except Non-Insulin Dependent Diabetes Mellitus (NIDDM) that is controlled and with hemoglobin A1c 8%.
- Evidence of active infection during screening, or serious infection within the past month.
- Patients with known Human Immunodeficiency Virus (HIV), hepatitis B or C virus (HBV) or (HCV), respectively), or active or latent Tuberculosis (TB).
- Serious or non-healing wound, skin ulcer, or bone fracture.
- Abdominal fistula, GI perforation, or intra-abdominal abscess within the past 6 months.
- Neuropathy of grade ≥2.
- Pregnant or lactating females.
- Patients like to purposely undergoing sunlight exposure, including the skin area where the plaques being investigated are located, during the study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Axis Clincals USA/ Red River Research Patners. LLC
Fargo, North Dakota, 58104
Kristen Peterson, 701-866-3026, k.peterson@axisclinicals.com
Michael Blankenship, MD
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19140
Sarmina Hassan, PhD, 215-707-1934
- Recruiting
NuLine Clinical Trial Center
Pompano Beach, Florida, 33060
Thalyat Jones, 855 501-1071, tjones@nulineclinicaltrial.com
About this study
Official title: A Study of Improvement in Psoriasis Symptoms Associated with Combinations of Biologically Active Natural Substances (SFA-002) with Known Safety Profile
The purpose of this study is to determine the safety, metabolism and potential effect of drug product SFA-002 on mild moderate and severe chronic plaque psoriasis. Psoriasis is a common chronic skin disorder that affects over 4 million people. There is no cure for psoriasis and treatment is directed at controlling patients' symptoms.
Read the detailed description
Up to ninety volunteers with mild to moderate chronic plaque psoriasis will be recruited for an open label 24 week prospective study of the safety of 2 different dosages for 12 weeks of active therapy and 12 weeks of follow up. Blood will be drawn to determine any clinical effect on each group at the 12 week time mark and residual effects after 24 weeks. Throughout the study the investigators will perform both clinical and laboratory assessments to measure safety and response.
- Conditions
- Psoriasis
- Being tested
- SFA002
- Keywords
- Mild Plaques psoriais, moderate Plaque Psoriasis, Severe plaque psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFA002Drug
Study drug formula without excipient
SFA002Drug
Study Drug SFA002 with excipient (Propionate)
| Study group | Role | What they receive |
|---|---|---|
| Drug (SFA002) Formula 1 | Experimental | Not described Receives: Drug: SFA002 |
| Drug (SFA002) Formula 2 | Experimental | Not described Receives: Drug: SFA002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index (PASI) Score
+/- % Change in Psoriasis (PASI) index from baseline measurement at first dose
Measured: From enrollment to final visit at 24 weeks treatment and 4 week follow-up
Secondary outcomes (1)
Change in IGA score
% Patients achieving 2 point change in IGA Score on 5 point scale and/or score of 2 (almost clear) or 1 Clear.
Measured: From enrollment to final visit at 24 weeks treatment and 4 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start31 Mar 2022
- Primary completion30 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SFA Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642182
- Sponsor's protocol ID
- SFA002-002
- Status last verified
- Jan 2025
- First submitted
- 3 May 2022
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Improvement in Psoriasis Symptoms Associated with Combinations of Biologically Active Natural Substances (SFA-002) with Known Safety Profile
- ClinicalTrials.gov ID
- NCT05642182
- Acronym / sponsor ID
- SFA002-002
- Conditions
- Psoriasis
- Keywords
- Mild Plaques psoriais, moderate Plaque Psoriasis, Severe plaque psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- SFA TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 8 Dec 2022 (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.
The purpose of this study is to determine the safety, metabolism and potential effect of drug product SFA-002 on mild moderate and severe chronic plaque psoriasis. Psoriasis is a common chronic skin disorder that affects over 4 million people. There is no cure for psoriasis and treatment is directed at controlling patients' symptoms.
Detailed description
Up to ninety volunteers with mild to moderate chronic plaque psoriasis will be recruited for an open label 24 week prospective study of the safety of 2 different dosages for 12 weeks of active therapy and 12 weeks of follow up. Blood will be drawn to determine any clinical effect on each group at the 12 week time mark and residual effects after 24 weeks. Throughout the study the investigators will perform both clinical and laboratory assessments to measure safety and response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| Drug (SFA002) Formula 1 | Experimental | Drug: SFA002 |
| Drug (SFA002) Formula 2 | Experimental | Drug: SFA002 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects of both sexes ≥18 years of age with at least one skin plaque that is >5 cm2 due to known psoriasis considered clinically to be MILD to MODERATE or MODERATE to SEVERE during evaluation and diagnosis at least 1 year prior. Mild is defined as "Just detectable to mild thickening; pink to light red coloration; predominantly fine scaling", whereas moderate is defined as "Clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling".
- Have or have not been treated with phototherapy, systemic therapy, or other therapies for their psoriasis
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use effective contraceptive methods (such as abstinence, intrauterine device (IUD), or double barrier device) during the study and for at least 3 months following completion of the study.
- Mentally competent, able to understand and willingness to sign the Informed Consent Form (ICF).
- Able to undergo the investigations and to follow the visit schedule stated in the study protocol.
Key exclusion criteria (19 listed)
- The forms of psoriasis other than chronic plaque psoriasis (such as drug-induced psoriasis or guttate, erythrodermic, or pustular psoriasis) or if the psoriasis does not meet the criterion of chronicity (defined as a clinically significant flare of psoriasis within 12 weeks before baseline).
- Presence of other form of inflammatory skin diseases (such as atopic dermatitis) or infectious diseases (such as cellulitis, warts, fungal cutaneous diseases, etc.)
- A clinically significant flare of psoriasis within 12 weeks before baseline. (Note: The determination of whether prospective study participants had a "significant flare" prior to study baseline is left to the investigators. The intent of this criterion was to ensure the condition is sufficiently stable and aligned with the chronic nature of plaque psoriasis, so that an adequate assessment of the efficacy could be made.)
- Prior or current use of psoriasis medications that might confound assessment of efficacy of the investigational supplements used in this study, unless there were used before their washout period prior to study initiation (see Table 2 for specific medications and their washout periods).
- Known serious medical illness, such as significant cardiac disease (e.g., symptomatic congestive heart failure, unstable angina pectoris, symptomatic coronary artery disease, myocardial infarction within the past 6 months, uncontrolled or symptomatic cardiac arrhythmia, or New York Heart Association Class III or IV), or severe debilitating pulmonary disease, that would potentially increase subjects' risk for toxicity.
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 |
|---|---|---|
| SFA002Study drug formula without excipient | Drug | Drug (SFA002) Formula 1 |
| SFA002Study Drug SFA002 with excipient (Propionate) | Drug | Drug (SFA002) Formula 2 |
Primary outcome
Psoriasis Area and Severity Index (PASI) Score
Time frame: From enrollment to final visit at 24 weeks treatment and 4 week follow-up
+/- % Change in Psoriasis (PASI) index from baseline measurement at first dose
1 secondary outcome
Change in IGA score
Time frame: From enrollment to final visit at 24 weeks treatment and 4 week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SFA002 in people with Psoriasis, run by SFA Therapeutics at 3 sites in United States.
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 5 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VP Development (267-625-4873, info@sfatherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Severity Index (PASI) Score (time frame: From enrollment to final visit at 24 weeks treatment and 4 week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2025.