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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
Awards & highlights
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 belowSelect...
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
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
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.
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Who is running the clinical trial?
Phoenicis TherapeuticsLead Sponsor
2 Previous Clinical Trials
10 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had active Hidradenitis Suppurativa for at least 2 months.You have more than 15 active tunnels during the screening process.I have 5 or more abscesses or painful bumps.I have not taken any medication that interacts with CYP3A4 in the last 2 weeks.The doctor thinks it's hard to tell if the disease is getting worse or if it's just scarring.I have had symptoms of HS for at least 6 months.I agree to follow the wound care and antibiotic treatment plan during the trial.I have a skin condition that could affect HS assessment.I have not taken any biologic drugs recently.I have a history of eye disease or significant heart or blood conditions.You have tested positive for tuberculosis (TB), HIV, hepatitis B, or hepatitis C during the screening process.I have had cancer before, but it was not skin cancer or cervical cancer.I started taking oral antibiotics less than 28 days ago.
Research Study Groups:
This trial has the following groups:- Group 1: PTM-001 400 mg daily for 12 weeks
- Group 2: Placebo daily for 12 weeks
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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