Testing a new drug for mild to moderate psoriasis plaques

A Study of Improvement in Psoriasis Symptoms Associated with Combinations of Biologically Active Natural Substances (SFA-002) with Known Safety Profile

This study is testing a new drug called SFA-002 to see if it can safely help people with mild to moderate psoriasis plaques feel better over 24 weeks.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: SFA Therapeutics (Industry-sponsored)
• Locations: 3 sites (Pompano Beach, Florida and 2 other locations)
• Trial ID: NCT05642182 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the drug SFA-002 in patients with mild to moderate chronic plaque psoriasis. Up to ninety volunteers will participate in an open-label trial lasting 24 weeks, which includes 12 weeks of active treatment followed by 12 weeks of follow-up. Participants will undergo clinical and laboratory assessments to monitor safety and any clinical effects of the drug. Blood samples will be collected to assess the drug's metabolism and potential impact on psoriasis symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with at least one psoriasis plaque greater than 5 cm² classified as mild to moderate.

Not a fit: Patients with severe psoriasis plaques or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from mild to moderate psoriasis.

How similar studies have performed: While there have been studies on psoriasis treatments, the specific approach of SFA-002 is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* 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

Where this trial is running

Pompano Beach, Florida and 2 other locations

• NuLine Clinical Trial Center — Pompano Beach, Florida, United States (Recruiting)
• Axis Clincals USA/ Red River Research Patners. LLC — Fargo, North Dakota, United States (Recruiting)
• Temple University — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: VP Development

Conditions Psoriasis; Mild Plaques psoriais; moderate Plaque Psoriasis; Severe plaque psoriasis