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Study of SFA002 in Patients With Mild to Moderate Psoriasis Plaques

Primary Purpose

Psoriasis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Drug (SFA002) Vitamin D, Magnesium
Drug (SFA002) Vitamin D, Magnesium and Propionate
Sponsored by
SFA Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Mild, moderate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Axis Clincals USARecruiting
  • Temple UniversityRecruiting
  • Tranquil Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Drug (SFA002) Vitamin D, Magnesium

Drug (SFA002) Vitamin D, Magnesium and Propionate

Arm Description

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

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

Outcomes

Primary Outcome Measures

Psoriasis Area and Severity Index (PASI) Score
+/- % Change in Psoriasis (PASI) index from baseline measurement at first dose

Secondary Outcome Measures

Full Information

First Posted
May 3, 2022
Last Updated
October 19, 2023
Sponsor
SFA Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05642182
Brief Title
Study of SFA002 in Patients With Mild to Moderate Psoriasis Plaques
Official Title
A Study of Improvement in Psoriasis Symptoms Associated With Combinations of Biologically Active Natural Substances (SFA-002) With Known Safety Profile
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SFA Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Mild, moderate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug (SFA002) Vitamin D, Magnesium
Arm Type
Experimental
Arm Description
Drug (SFA002) 1000 mg, 80 mg Calcium, 40 mg Magnesium 3 times daily after meals and Vitamin D 1000 IU once daily
Arm Title
Drug (SFA002) Vitamin D, Magnesium and Propionate
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Drug (SFA002) Vitamin D, Magnesium
Intervention Description
Capsules
Intervention Type
Drug
Intervention Name(s)
Drug (SFA002) Vitamin D, Magnesium and Propionate
Intervention Description
Capsules
Primary Outcome Measure Information:
Title
Psoriasis Area and Severity Index (PASI) Score
Description
+/- % Change in Psoriasis (PASI) index from baseline measurement at first dose
Time Frame
Three months after study end

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
VP Development
Phone
267-625-4873
Email
info@sfatherapeutics.com
Facility Information:
Facility Name
Axis Clincals USA
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Peterson
Phone
701-866-3026
Email
k.peterson@axisclinicals.com
First Name & Middle Initial & Last Name & Degree
Michael Blankenship, MD
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarmina Hassan, PhD
Phone
215-707-1934
Facility Name
Tranquil Clinical Research
City
Webster
State/Province
Texas
ZIP/Postal Code
77158
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

Study of SFA002 in Patients With Mild to Moderate Psoriasis Plaques

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