What side effects are associated with this type of intervention?

Common treatments for psoriasis that focus on immune modulation or inflammation reduction include TNF-alpha inhibitors (e.g., infliximab, adalimumab), IL-12/23 inhibitors (e.g., ustekinumab), and other biologics (e.g., secukinumab, ixekizumab). Known side effects of these treatments can include increased risk of infections, injection site reactions, and potential exacerbation of pre-existing conditions such as inflammatory bowel disease. Long-term use may also be associated with an increased risk of malignancies and cardiovascular events. Patients should discuss these risks with their healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

Several FDA-approved treatments for psoriasis focus on immune modulation and inflammation reduction. These include TNF-alpha inhibitors such as etanercept, adalimumab, infliximab, certolizumab pegol, and golimumab, which have shown efficacy in reducing inflammation and modulating immune responses. Additionally, interleukin inhibitors like ustekinumab (IL-12/23 inhibitor), secukinumab, and ixekizumab (both IL-17 inhibitors) are approved for their ability to target specific pathways in the immune system. Other treatments include methotrexate, a systemic immunomodulator, and newer agents like apremilast, a phosphodiesterase 4 inhibitor, which also modulates inflammatory pathways.

What other types of research exist?

Promising novel alternatives to SFA004 for psoriasis treatment include: 1) Vunakizumab (SHR-1314), an interleukin 17A monoclonal antibody, which has shown efficacy and safety in a phase II study for moderate-to-severe plaque psoriasis. 2) Risankizumab, an anti-interleukin (IL)-23p19 biologic, which has demonstrated superior efficacy compared to ustekinumab in phase III trials. 3) Brodalumab, an IL-17 receptor antagonist, which has shown long-term efficacy and safety in treating psoriasis. These alternatives offer new mechanisms of action targeting immune pathways involved in psoriasis.

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SFA002 + Supplements for Psoriasis

Phase 1

Recruiting

Research Sponsored by SFA Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

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.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three months after study end

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called SFA004 on people with mild to moderate chronic plaque psoriasis to see if it is safe and effective. The study will last several months, with different dosages given for the first part and follow-up for the remaining period. Researchers will use blood tests and other checks to monitor the drug's effects and safety.

Who is the study for?

Adults over 18 with mild to moderate chronic plaque psoriasis, who can consent and follow the study schedule. Women must use effective contraception. Excludes pregnant or breastfeeding women, those with serious illnesses like heart disease, uncontrolled bleeding, recent strokes, certain infections (HIV/HBV/HCV/TB), and those on conflicting medications.

What is being tested?

The trial is testing SFA002 combined with Vitamin D, Magnesium and Propionate for safety and effectiveness in treating mild to moderate psoriasis plaques. The goal is to control symptoms of this common skin disorder as there's no cure.

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical drug reactions such as skin irritation at the application site, allergic reactions, gastrointestinal issues or changes in blood levels of vitamin D and magnesium.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I experience shortness of breath with little activity and need frequent fluid drainage.

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I have high blood pressure or severe peripheral vascular disease.

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I have risk factors for a specific heart rhythm problem.

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I have a skin condition like eczema or a skin infection.

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I have a tumor or cancer spread to my brain or spinal cord.

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I do not have serious heart or severe lung conditions that could make treatment risky for me.

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I have not had any uncontrolled bleeding or bleeding disorders in the last 6 months.

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I do not have severe nerve pain or damage.

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I have had a stroke or a similar event in the last year.

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I have a serious or non-healing wound, skin ulcer, or bone fracture.

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I have HIV, hepatitis B or C, or active/latent TB.

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My psoriasis is not the chronic plaque type and has flared up within the last 3 months.

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I have not had a serious infection in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three months after study end

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~three months after study end

This trial's timeline: 3 weeks for screening, Varies for treatment, and three months after study end for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Psoriasis Area and Severity Index (PASI) Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Drug (SFA002) Vitamin D, Magnesium and PropionateExperimental Treatment1 Intervention

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

Group II: Drug (SFA002) Vitamin D, MagnesiumExperimental Treatment1 Intervention

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

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Psoriasis treatments often focus on immune modulation and inflammation reduction, targeting specific components of the immune system to mitigate the overactive immune response characteristic of the disease. TNF-alpha inhibitors (e.g., infliximab, adalimumab) block TNF-alpha, a cytokine that promotes inflammation. IL-12/23 inhibitors (e.g., ustekinumab) and IL-17 inhibitors (e.g., secukinumab) target other cytokines involved in the inflammatory process. By inhibiting these cytokines, these treatments reduce inflammation and slow down rapid skin cell turnover, leading to symptom improvement. This approach is crucial as it addresses the underlying cause of psoriasis, providing more effective and sustained symptom relief.

Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.TNFalpha blockade in human diseases: mechanisms and future directions.