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.

← Back to Search

PTM-001 for Hidradenitis Suppurativa

Phase 2

Recruiting

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 12

Awards & highlights

Study Summary

This triallooks at a new drug for HS sufferers, giving some patients the drug and others a placebo, to see if it helps treat their condition over 12 weeks.

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.Check my eligibility

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).See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effect of PTM-001 on IL-1β protein levels in lesional skin biopsies

Secondary outcome measures

Change in Pain, as measured using a 10-point numerical rating scale, 1 through 10, with 10 being the worst.

Change in Quality of Life using Dermatology Life Quality Index (DLQI)

Change in abscesses and inflammatory nodules count (AN count)

+9 more

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 / 2Eligibility 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.