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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.
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 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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
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 moreTrial 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
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Who is running the clinical trial?
Phoenicis TherapeuticsLead Sponsor
2 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people still being recruited for this experiment?
"That is correct. Currently, the trial is looking for 50 individuals to participate at 3 different locations. The data on clinicaltrials.gov shows that recruitment started on 5/5/2022 and was last updated on 10/24/2022."
Answered by AI
How many patients are included in this test group?
"Yes, that is accurate. The information available on clinicaltrials.gov indicates that this research is looking for subjects right now. This project was initially publicized on May 5th, 2022 and received its most recent update on October 24th, 2022. In total, they need 50 people to participate at 3 different locations."
Answered by AI
Has PTM-001 400 mg 12 weeks received FDA approval?
"PTM-001 400 mg daily for 12 weeks received a safety score of 2. This is due to the lack of available data regarding efficacy, though there are reports supporting its safety."
Answered by AI
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