Study of SFA002 in Patients With Mild to Moderate Psoriasis Plaques

Study Purpose

The purpose of this study is to determine the safety, metabolism and potential effect of drug product SFA004 on mild to moderate 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05642182
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

SFA Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Additional Details

Up to sixty 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.

Arms & Interventions

Arms

Experimental: Drug (SFA002) Vitamin D, Magnesium

Drug (SFA002) 1000 mg, 80 mg Calcium, 40 mg Magnesium 3 times daily after meals and Vitamin D 1000 IU once daily

Experimental: Drug (SFA002) Vitamin D, Magnesium and Propionate

Drug (SFA002) 1000 mg, Propionate 150 mg, 80 mg Calcium, 40 mg Magnesium 3 times daily after meals and Vitamin D 1000 mg once daily

Interventions

Drug: - Drug (SFA002) Vitamin D, Magnesium

Capsules

Drug: - Drug (SFA002) Vitamin D, Magnesium and Propionate

Capsules

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

NuLine Clinical Trial Center, Pompano Beach, Florida

Status

Recruiting

Address

NuLine Clinical Trial Center

Pompano Beach, Florida, 33060

Site Contact

Thalyat Jones

tjones@nulineclinicaltrial.com

855-501-1071

Brock Clinical Research, Baltimore, Maryland

Status

Recruiting

Address

Brock Clinical Research

Baltimore, Maryland, 21237

Site Contact

Ernestine Copeland

Copelanderenstine30@outlook.com

443-915-2154

Axis Clincals USA, Fargo, North Dakota

Status

Recruiting

Address

Axis Clincals USA

Fargo, North Dakota, 58104

Site Contact

Kristen Peterson

k.peterson@axisclinicals.com

701-866-3026

Temple University, Philadelphia, Pennsylvania

Status

Recruiting

Address

Temple University

Philadelphia, Pennsylvania, 19140

Site Contact

Sarmina Hassan, PhD

info@sfatherapeutics.com

215-707-1934

Tranquil Clinical Research, Webster, Texas

Status

Completed

Address

Tranquil Clinical Research

Webster, Texas, 77158

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