SFA002 + Supplements for Psoriasis

Recruiting at 3 trial locations

Overseen By VP Development

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: SFA Therapeutics

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effects of a new drug, SFA002, for treating chronic plaque psoriasis, a common skin condition that causes itchy, red patches. The study will explore two different formulas of the drug to determine which works best. People with mild to severe psoriasis for at least a year and a stable condition (no significant worsening in the last 12 weeks) might be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that SFA-002 appears safe for treating psoriasis. In a recent study, SFA-002 met its safety goals, with no harmful effects reported. Participants did not experience any negative side effects.

Although it's still early, these results suggest that SFA-002 is well-tolerated by individuals with mild to moderate psoriasis. This is encouraging for those considering joining a trial, as it indicates a positive safety profile for this treatment so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about SFA002 for treating psoriasis because it offers a fresh approach compared to standard treatments like topical corticosteroids or biologics. Unlike these common options that primarily focus on reducing inflammation, SFA002 may work by targeting specific pathways involved in the skin's immune response, potentially offering a more precise treatment. Additionally, the use of two different formulas of SFA002 could allow for tailored treatment options, optimizing effectiveness and minimizing side effects for patients. This new method of action is what makes SFA002 stand out as a promising candidate in the fight against psoriasis.

What evidence suggests that this trial's treatments could be effective for psoriasis?

Research has shown that SFA002 may help treat psoriasis. In an earlier study, patients using SFA002 experienced a significant drop in their Psoriasis Area and Severity Index (PASI), a measure of psoriasis impact on the skin. In animal studies, SFA002 reduced skin thickening and disease severity more effectively than some current treatments, such as etanercept and apremilast. This trial will test two different formulations of SFA002, labeled Formula 1 and Formula 2. Although these results are preliminary, they suggest that SFA002 could become a new option for people with psoriasis. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• SFA002
• SFA004

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

Brodalumab, an IL-17 antagonist approved for moderate-to-severe plaque psoriasis, has a safety profile similar to other IL-17 treatments, based on data from phase II and III clinical trials.

While common adverse events include nasopharyngitis and upper respiratory infections, a significant concern arose from six reported suicides among patients, leading to a black box warning, although no direct causal link was established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brodalumab: A Review of Safety. Rusta-Sallehy, S., Gooderham, M., Papp, K.[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]

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]

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]

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]

Citations

1. sfatherapeutics.com sfatherapeutics.com/news/sfa-therapeutics-announces-positive-phase-1b-data-of-sfa-002-in-mild-to-moderate-psoriasis

SFA Therapeutics Announces Positive Phase 1b Data of SFA ... SFA-002 met its exploratory endpoint of efficacy. Patients administered SFA-002 demonstrated statistically significant Psoriasis Area and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05642182

Study of SFA002 in Patients with Mild to Moderate ... 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 ...

3. sfatherapeutics.com sfatherapeutics.com/news/head-to-head-preclinical-studies-of-sfa-002-as-a-novel-psoriasis-treatment-presented-at-the-2025-american-academy-of-dermatology-annual-meeting

Head-to-Head Preclinical Studies of SFA-002 as a Novel ... Mice dosed with SFA-002 displayed reduction in psoriasis disease severity and greater reduction in skin thickening compared to etanercept and apremilast in the ...

4. withpower.com withpower.com/trial/phase-1-psoriasis-2-2022-5feba

SFA002 + Supplements for Psoriasis 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 ...

5. prnewswire.com prnewswire.com/news-releases/sfa-therapeutics-announces-positive-phase-1b-data-of-sfa-002-in-mild-to-moderate-psoriasis-302395342.html

SFA Therapeutics Announces Positive Phase 1b Data ... SFA-002 met its exploratory endpoint of efficacy. Patients administered SFA-002 demonstrated statistically significant Psoriasis Area and ...

6. clinicaltrialsarena.com clinicaltrialsarena.com/news/sfa-therapeutics-psoriasis-trial-extended-data/

SFA released updated data from Phase Ib SFA-002 ... SFA Therapeutics has announced that 92% of patients with plaque psoriasis achieved a Psoriasis Area and Severity Index (PASI) score of greater than 50 in the ...