SFA002 + Supplements for Psoriasis

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: SFA Therapeutics

Disqualifiers: Other psoriasis, Cardiac disease, CNS tumor, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial protocol mentions that prior or current use of psoriasis medications that might affect the study's results should be stopped before the trial, with specific washout periods required. However, it does not specify which medications or the exact washout periods, so you may need to discuss your current medications with the study team.

What data supports the effectiveness of the drug SFA002 for treating psoriasis?

Research shows that fumaric acid esters (FAEs), which may be related to SFA002, can reduce inflammation in psoriasis by decreasing certain immune cells and skin thickening, similar to the effects of another psoriasis drug, cyclosporin, although it takes longer to see results. ^{1 2 3 4 5}

Is SFA002 safe for humans?

Fumaric acid esters (FAE), which include SFA002, have been used for treating psoriasis and are generally considered safe, with common side effects like stomach upset and flushing. Rarely, they can cause proteinuria (protein in urine), but serious kidney issues are uncommon. Long-term studies suggest they are safe for extended use. ^{6 7 8 9 10}

How does the drug SFA002 differ from other psoriasis treatments?

The drug SFA002, combined with supplements, is unique for psoriasis treatment as it may involve a novel combination of ingredients or a different mechanism of action compared to standard treatments like fumaric acid esters, which are known for their immunosuppressive effects. However, specific details about SFA002's mechanism or components are not provided in the available research. ^{1 10 11 12 13}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I understand the study details and am willing to sign the consent form.

I am using effective birth control or will for 3 months after the study ends.

I am over 18 and have a psoriasis plaque larger than 5 cm2, diagnosed as mild to moderate.

Exclusion Criteria

I have high blood pressure or severe peripheral vascular disease.

I have stopped using certain psoriasis medications as required before starting this study.

I have not had an abdominal fistula, GI perforation, or abscess in the last 6 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SFA-002 for 12 weeks to assess safety and efficacy

12 weeks

Regular visits for clinical and laboratory assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Visits for clinical and laboratory assessments

Treatment Details

Interventions

• SFA002 (Other)
• SFA004 (Other)

Trial Overview 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.

Participant Groups

Group I: Drug (SFA002) Formula 2 Experimental Treatment 1 Intervention

Group II: Drug (SFA002) Formula 1 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

SFA Therapeutics

Lead Sponsor

Trials

2

Recruited

220+

Findings from Research

Systemic administration of fumaric acid esters (FAEs) leads to a significant reduction in inflammatory cells, particularly CD 15-positive cells and T-helper cells, indicating an immunosuppressive effect in psoriatic plaques.

While FAEs effectively reduce epidermal thickness and inflammation, the normalization of psoriatic plaques occurs more slowly compared to treatments like cyclosporin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fumaric acid esters (FAEs) suppress CD 15- and ODP 4-positive cells in psoriasis. Bacharach-Buhles, M., Pawlak, FM., Matthes, U., et al.[2017]

A study of 1891 Canadian patients with moderate-to-severe psoriasis showed that those treated with ixekizumab had high adherence rates of 92% at 1 year and 87.7% at 2 years, indicating effective management of their condition.

Biologic-naïve patients demonstrated significantly higher persistence and adherence to ixekizumab treatment compared to those who had prior biologic experience, suggesting that treatment history may influence patient commitment to therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Persistence of Ixekizumab in Adults with Moderate-to-Severe Plaque Psoriasis Participating in the Canadian Patient Support Program. Gulliver, W., Gooderham, MJ., Zhu, B., et al.[2023]

In a study of 149 patients with mild-to-moderate psoriasis, proactive management using Cal/BD foam significantly reduced the number of relapses and increased the time to first relapse compared to reactive treatment over a 52-week period.

The proactive treatment showed no signs of skin atrophy, as confirmed by dermoscopic and confocal microscopy analyses, while also improving overall psoriasis severity scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proactive vs. reactive psoriasis therapy: a long-term evaluation with dermoscopic and confocal microscopy assessment. Cacciapuoti, S., Ruggiero, A., Gallo, L., et al.[2022]

In a study of 58 hospitalized patients with severe forms of psoriasis, supplementation with antioxidants (coenzyme Q10, vitamin E, and selenium) for 30-35 days led to significant clinical improvements and faster normalization of oxidative stress markers compared to a placebo group.

Patients showed increased oxidative stress at baseline, but antioxidant supplementation effectively reduced these markers, suggesting that it could be a beneficial management strategy for severe erythrodermic and arthropathic psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and biochemical effects of coenzyme Q(10), vitamin E, and selenium supplementation to psoriasis patients. Kharaeva, Z., Gostova, E., De Luca, C., et al.[2014]

In a 12-week trial involving 142 adult patients with moderate-to-severe plaque psoriasis, etanercept 50 mg once weekly significantly improved quality of life (QoL) measures compared to placebo, as indicated by better Dermatology Life Quality Index (DLQI) and EuroQoL-5D (EQ-5D) scores.

After 24 weeks of treatment, patients reported that psoriasis had a minimal effect on their QoL, with EQ-5D and FACIT-F scores aligning closely with general population norms, demonstrating the efficacy of etanercept in alleviating the impact of psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-weekly administration of etanercept 50 mg improves patient-reported outcomes in patients with moderate-to-severe plaque psoriasis. Reich, K., Segaert, S., Van de Kerkhof, P., et al.[2015]

In a study of 66 patients with severe psoriasis, long-term therapy with fumaric acid esters (FAE) was found to be generally safe, with 73% of patients reporting mild adverse events such as flushing and diarrhea.

Despite some patients experiencing relative lymphocytopenia and other mild side effects, the overall findings support the use of FAE as a viable long-term treatment option for severe psoriasis, with follow-up periods extending up to 14 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety aspects of systemic therapy with fumaric acid esters in severe psoriasis. Hoefnagel, JJ., Thio, HB., Willemze, R., et al.[2019]

Fumaric acid ester (FAE) therapy has been shown to be both safe and effective for treating severe psoriasis vulgaris, with multicenter trials confirming its benefits and defining its adverse effects.

The mechanism of action for FAEs appears to involve shifting the immune response from a Th1-dominated profile to a Th2-like pattern, along with inhibiting the proliferation of skin cells (keratinocytes), although the exact process is still not fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of severe psoriasis with fumaric acid esters: scientific background and guidelines for therapeutic use. The German Fumaric Acid Ester Consensus Conference. Mrowietz, U., Christophers, E., Altmeyer, P.[2019]

Fumaric acid esters (FAE) are generally considered safe for treating psoriasis, with common side effects being gastrointestinal issues and transient flushing, but recent cases have raised concerns about reversible proteinuria as a potential adverse effect.

Despite the occurrence of proteinuria in a few patients, the overall safety profile of FAE remains strong, and the novel agent dimethylfumaric (DMF) has shown efficacy in psoriasis without renal toxicity, suggesting it should be further developed for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proteinuria with fumaric acid ester treatment for psoriasis. Ogilvie, S., Lewis Jones, S., Dawe, R., et al.[2011]

Oral fumaric acid esters (FAE), including dimethyl fumarate, show significant efficacy in reducing psoriasis severity compared to placebo, with 64% of participants achieving a 50% improvement in their Psoriasis Area and Severity Index (PASI) score.

FAE are associated with common mild adverse effects, such as gastrointestinal disturbances and flushing, but no serious adverse effects were reported in the short-term studies, indicating a relatively safe profile for short-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral fumaric acid esters for psoriasis. Atwan, A., Ingram, JR., Abbott, R., et al.[2022]

In a pilot study of 36 patients, fumaric acid therapy (FACT) showed effectiveness in treating psoriasis, particularly with the dimethylfumaric acid ester (DMFAE) at a dosage of 240 mg daily, which significantly improved symptoms and prevented the extension of the skin eruption.

However, side effects were notable, including nausea, diarrhea, and mild liver and kidney function disturbances, with about 50% of patients experiencing a decrease in suppressor T lymphocytes, indicating potential safety concerns with this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic therapy with fumaric acid derivates: new possibilities in the treatment of psoriasis. Nieboer, C., de Hoop, D., van Loenen, AC., et al.[2019]

The study developed and validated stability-indicating methods for analyzing a mixture of mometasone furoate (MF) and calcipotriol (CP), ensuring accurate quality control for these psoriasis treatments under various stress conditions.

The major degradation products of MF were identified under different conditions, but no new impurities were found in the MF and CP mixtures, indicating that the combination is stable and safe for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous determination of mometasone furoate and calcipotriol in a binary mixture by validated HPLC and chemometric-assisted UV spectrophotometric methods and identification of degradation products by LC-MS. Jahani, M., Akaberi, M., Heidari, T., et al.[2023]

In a study of 176 patients with moderate to severe psoriasis treated with high-dose dimethylfumarate (DMF) for a median of 28 months, psoriasis activity significantly decreased by 1.7 points on a five-point scale, indicating its effectiveness as a treatment.

While 152 patients experienced adverse events, primarily gastrointestinal issues and flushing, the overall findings suggest that high-dose DMF monotherapy is a safe option, with about 50% of patients benefiting from the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and effectiveness of high-dose dimethylfumarate in the treatment of moderate to severe psoriasis: a prospective single-blinded follow-up study. Lijnen, R., Otters, E., Balak, D., et al.[2018]

References

1. Norway pubmed.ncbi.nlm.nih.gov

Fumaric acid esters (FAEs) suppress CD 15- and ODP 4-positive cells in psoriasis. [2017]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment Persistence of Ixekizumab in Adults with Moderate-to-Severe Plaque Psoriasis Participating in the Canadian Patient Support Program. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

Proactive vs. reactive psoriasis therapy: a long-term evaluation with dermoscopic and confocal microscopy assessment. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical and biochemical effects of coenzyme Q(10), vitamin E, and selenium supplementation to psoriasis patients. [2014]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Once-weekly administration of etanercept 50 mg improves patient-reported outcomes in patients with moderate-to-severe plaque psoriasis. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Long-term safety aspects of systemic therapy with fumaric acid esters in severe psoriasis. [2019]

7. Canada pubmed.ncbi.nlm.nih.gov

Brodalumab: A Review of Safety. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Treatment of severe psoriasis with fumaric acid esters: scientific background and guidelines for therapeutic use. The German Fumaric Acid Ester Consensus Conference. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Proteinuria with fumaric acid ester treatment for psoriasis. [2011]

10. England pubmed.ncbi.nlm.nih.gov

Oral fumaric acid esters for psoriasis. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Systemic therapy with fumaric acid derivates: new possibilities in the treatment of psoriasis. [2019]

12. Iran pubmed.ncbi.nlm.nih.gov

Simultaneous determination of mometasone furoate and calcipotriol in a binary mixture by validated HPLC and chemometric-assisted UV spectrophotometric methods and identification of degradation products by LC-MS. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Long-term safety and effectiveness of high-dose dimethylfumarate in the treatment of moderate to severe psoriasis: a prospective single-blinded follow-up study. [2018]