What is the mechanism of action of this treatment?

Hidradenitis Suppurativa (HS) is often treated with immunomodulatory therapies that target the dysregulated immune response characteristic of the disease. Common treatments include TNF-alpha inhibitors (such as adalimumab and infliximab), which reduce inflammation by blocking the activity of tumor necrosis factor-alpha, a key cytokine in the inflammatory process. Other treatments like Janus kinase (JAK) inhibitors (e.g., tofacitinib) interfere with signaling pathways that promote inflammation. These therapies are crucial for HS patients as they help to control the chronic inflammation, reduce the formation of painful nodules and abscesses, and improve overall quality of life by addressing the underlying immune dysfunction.

What side effects are associated with this type of intervention?

Common treatments for Hidradenitis Suppurativa (HS) include zinc gluconate, fumarates, vitamin D3 supplementation, and ionizing radiation. Zinc gluconate may cause gastrointestinal upset and reduce copper absorption. Fumarates, while anti-inflammatory, have limited efficacy and can lead to treatment discontinuation due to lack of improvement. Vitamin D3 supplementation is generally well-tolerated but requires further study to confirm its efficacy. Ionizing radiation has shown some benefit but carries risks of long-term adverse effects. Immunomodulatory treatments like PTM-001 are being studied for their potential benefits, but specific side effects are not detailed in the provided context.

What prior FDA approvals exist?

The FDA has approved several immunomodulatory treatments for Hidradenitis Suppurativa (HS). One notable example is adalimumab (Humira), a TNF-alpha inhibitor, which was the first FDA-approved biologic for HS. It works by modulating the immune response to reduce inflammation. Other treatments under investigation or in use include various biologics targeting different inflammatory pathways, such as IL-17 inhibitors. These treatments aim to control the immune system's overactivity, which is a key factor in HS pathogenesis.

What other types of research exist?

Promising novel alternatives to PTM-001 for Hidradenitis Suppurativa patients include: 1) Adalimumab, a TNF-alpha inhibitor, which has shown efficacy in HS. 2) Secukinumab, an IL-17A inhibitor, which has been effective in treating other inflammatory skin conditions like psoriasis and may offer benefits for HS. 3) Infliximab, another TNF-alpha inhibitor, which has been used successfully in severe cases of inflammatory skin diseases. These alternatives have demonstrated potential in clinical trials and could be considered for HS treatment in 2024.

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PTM-001 for Hidradenitis Suppurativa

Phase 2

Waitlist Available

Research Sponsored by Phoenicis Therapeutics

Eligibility Criteria Checklist

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

Must have

Has ≥ 5 HS abscesses or inflammatory nodules at Screening.

Agrees to maintain baseline wound care and antibiotic therapy, including oral antibiotics, for the duration of the trial.

Must not have

Has a history of retinopathy or known clinically significant cardiovascular or hematologic conditions.

Has a history of malignancy except non-melanoma skin cancer or cervical carcinoma in situ.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests PTM-001, a medication, on people with Hidradenitis Suppurativa to see if it can reduce their symptoms by modifying the immune system's response.

Who is the study for?

This trial is for individuals with Hidradenitis Suppurativa (HS) who've had symptoms for at least 6 months, active HS for 2 months, and have 5 or more abscesses or nodules. They must agree to maintain current wound care and antibiotics, and use contraception. Excluded are those with extensive scarring, other skin conditions affecting assessments, recent biologic drug use, certain medication interactions, significant health issues like retinopathy or infections like TB/HIV/hepatitis.

What is being tested?

The study tests PTM-001's effect on HS over a period of 12 weeks against a placebo in a double-blind setup; participants don't know if they're getting the real treatment or not. After this phase, all participants receive PTM-001 openly for another 12 weeks. The process includes stratification by disease severity (Hurley Stage).

What are the potential side effects?

While specific side effects aren't listed here, immunomodulatory drugs like PTM-001 can generally cause immune system changes leading to increased infection risk and potential reactions at injection sites among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have 5 or more abscesses or painful bumps.

Select...

I agree to follow the wound care and antibiotic treatment plan during the trial.

Exclusion Criteria

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

Select...

I have a history of eye disease or significant heart or blood conditions.

Select...

I have had cancer before, but it was not skin cancer or cervical cancer.

Select...

I started taking oral antibiotics less than 28 days ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PTM-001 400 mg daily for 12 weeksExperimental Treatment1 Intervention

Group II: Placebo daily for 12 weeksPlacebo Group1 Intervention

0 / 5Eligibility 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

Hidradenitis Suppurativa (HS) is often treated with immunomodulatory therapies that target the dysregulated immune response characteristic of the disease. Common treatments include TNF-alpha inhibitors (such as adalimumab and infliximab), which reduce inflammation by blocking the activity of tumor necrosis factor-alpha, a key cytokine in the inflammatory process. Other treatments like Janus kinase (JAK) inhibitors (e.g., tofacitinib) interfere with signaling pathways that promote inflammation. These therapies are crucial for HS patients as they help to control the chronic inflammation, reduce the formation of painful nodules and abscesses, and improve overall quality of life by addressing the underlying immune dysfunction.