Study of SFA002 in Patients with Mild to Moderate Psoriasis Plaques

Last updated: January 7, 2025
Sponsor: SFA Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Warts

Rosacea

Rash

Treatment

SFA002

Drug (SFA002) Vitamin D, Magnesium and Propionate

Drug (SFA002) Vitamin D, Magnesium

Clinical Study ID

NCT05642182
SFA002-002
  • Ages > 18
  • All Genders

Study 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. There is no cure for psoriasis and treatment is directed at controlling patients' symptoms.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects of both sexes ≥18 years of age with at least one skin plaque that is >5 cm2due to known psoriasis considered clinically to be MILD to MODERATE or MODERATE toSEVERE during evaluation and diagnosis at least 1 year prior. Mild is defined as "Just detectable to mild thickening; pink to light red coloration; predominantlyfine scaling", whereas moderate is defined as "Clearly distinguishable to moderatethickening; dull to bright red, clearly distinguishable to moderate thickening;moderate scaling".

  • Have or have not been treated with phototherapy, systemic therapy, or othertherapies for their psoriasis

  • Women of child-bearing potential (i.e., women who are pre-menopausal or notsurgically sterile) must use effective contraceptive methods (such as abstinence,intrauterine device (IUD), or double barrier device) during the study and for atleast 3 months following completion of the study.

  • Mentally competent, able to understand and willingness to sign the Informed ConsentForm (ICF).

  • Able to undergo the investigations and to follow the visit schedule stated in thestudy protocol.

Exclusion

Exclusion Criteria:

  • The forms of psoriasis other than chronic plaque psoriasis (such as drug-inducedpsoriasis or guttate, erythrodermic, or pustular psoriasis) or if the psoriasis doesnot meet the criterion of chronicity (defined as a clinically significant flare ofpsoriasis within 12 weeks before baseline).

  • Presence of other form of inflammatory skin diseases (such as atopic dermatitis) orinfectious 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 "significantflare" prior to study baseline is left to the investigators. The intent of thiscriterion was to ensure the condition is sufficiently stable and aligned with thechronic nature of plaque psoriasis, so that an adequate assessment of the efficacycould be made.)

  • Prior or current use of psoriasis medications that might confound assessment ofefficacy of the investigational supplements used in this study, unless there wereused before their washout period prior to study initiation (see Table 2 for specificmedications and their washout periods).

  • Known serious medical illness, such as significant cardiac disease (e.g.,symptomatic congestive heart failure, unstable angina pectoris, symptomatic coronaryartery disease, myocardial infarction within the past 6 months, uncontrolled orsymptomatic cardiac arrhythmia, or New York Heart Association Class III or IV), orsevere 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., clinicallysignificant heart failure, hypokalemia, family history of Long QT Syndrome).

  • Known to have arterial thrombotic event, stroke, or transient ischemia attack withinthe past 12 months.

  • Known to have uncontrolled hypertension (systolic blood pressure >160 mm Hg ordiastolic blood pressure >90 mm Hg), or peripheral vascular disease ≥grade 2.

  • Known to have active central nervous system (CNS), epidural tumor or metastasis, orbrain metastasis.

  • Any active uncontrolled bleeding, a bleeding diathesis (e.g., active peptic ulcerdisease), or a history of bleeding (e.g., hemoptysis, upper or lowergastrointestinal [GI] bleeding) within the past 6 months.

  • Dyspnea with minimal to moderate exertion; large and recurrent pleural or peritonealeffusions requiring frequent drainage (e.g. weekly); or any amount of clinicallysignificant pericardial effusion.

  • Diabetes of any type, except Non-Insulin Dependent Diabetes Mellitus (NIDDM) that iscontrolled and with hemoglobin A1c 8%.

  • Evidence of active infection during screening, or serious infection within the pastmonth.

  • 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 6months.

  • Neuropathy of grade ≥2.

  • Pregnant or lactating females.

  • Patients like to purposely undergoing sunlight exposure, including the skin areawhere the plaques being investigated are located, during the study

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: SFA002
Phase: 1
Study Start date:
March 31, 2022
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • NuLine Clinical Trial Center

    Pompano Beach, Florida 33060
    United States

    Active - Recruiting

  • Brock Clinical Research

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • Axis Clincals USA

    Fargo, North Dakota 58104
    United States

    Active - Recruiting

  • Axis Clincals USA/ Red River Research Patners. LLC

    Fargo, North Dakota 58104
    United States

    Active - Recruiting

  • Temple University

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • Tranquil Clinical Research

    Webster, Texas 77158
    United States

    Site Not Available

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