PTM-001 for Hidradenitis Suppurativa

Not currently recruiting at 2 trial locations

Overseen By Ramsey Johnson, MSM

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Phoenicis Therapeutics

Must be taking: Oral antibiotics

Must not be taking: Biologics, CYP3A4 interactors

Disqualifiers: TB, HIV, Hepatitis, Retinopathy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of the experimental drug PTM-001 for individuals with Hidradenitis Suppurativa (HS), a condition that causes painful skin lumps. Participants will take either PTM-001 or a placebo (a non-active substance) daily for 12 weeks, followed by all participants receiving PTM-001 for another 12 weeks. The goal is to determine if PTM-001 can reduce the inflammation and discomfort caused by HS. Individuals who have experienced HS symptoms for at least 6 months and currently have at least 5 abscesses or nodules may be suitable for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial requires you to maintain your current wound care and antibiotic therapy. However, you cannot start new oral antibiotics within 28 days before the trial or take certain medications that interact with the study drug within 2 weeks before starting. If you're on biologic drugs, you must stop them for a period based on their half-lives before joining.

Is there any evidence suggesting that PTM-001 is likely to be safe for humans?

Research shows that PTM-001 is being tested for safety in people with hidradenitis suppurativa (HS), a skin condition that causes painful lumps under the skin. Researchers are studying PTM-001 to determine if it can help by affecting the immune system.

Although clear information on PTM-001's safety is limited, its presence in a Phase 2 trial indicates some safety in earlier studies. Treatments reaching this phase have typically been tested in smaller groups and found to be generally safe.

Participants in the trial will take PTM-001 daily for 12 weeks, with close monitoring for any side effects. Those considering joining the trial should remember that safety is always a top priority in these studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Hidradenitis Suppurativa?

Unlike the standard treatments for hidradenitis suppurativa, such as antibiotics or biologics that target inflammation, PTM-001 offers a novel approach. PTM-001 is unique because it works by specifically targeting the pathways involved in the development of the painful nodules characteristic of this condition. This targeted mechanism of action could potentially lead to more effective management of symptoms with fewer side effects. Researchers are excited about PTM-001's potential to provide relief for patients who have not responded well to existing options.

What evidence suggests that PTM-001 might be an effective treatment for Hidradenitis Suppurativa?

Research suggests that PTM-001, which participants in this trial may receive, might help people with hidradenitis suppurativa (HS), a painful skin condition, by affecting the immune system. In other studies, PTM-001 has shown promise in reducing HS symptoms by calming the immune response. This could lead to fewer and less severe flare-ups for those with this condition. Although more research is needed, these early findings offer hope for improving life for people with HS. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had active Hidradenitis Suppurativa for at least 2 months.

Agrees to use contraception

I have 5 or more abscesses or painful bumps.

Exclusion Criteria

Is pregnant, nursing or considering becoming pregnant.

You have more than 15 active tunnels during the screening process.

I have not taken any medication that interacts with CYP3A4 in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PTM-001 (400 mg) or placebo daily for 12 weeks

12 weeks

Open-label extension

All participants receive open-label PTM-001 400 mg daily for an additional 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• PTM-001

Trial Overview 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).

How Is the Trial Designed?

Group I: PTM-001 400 mg daily for 12 weeks Experimental Treatment 1 Intervention

Group II: Placebo daily for 12 weeks Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Phoenicis Therapeutics

Lead Sponsor

Trials

3

Recruited

60+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05020730

Study Details | NCT05020730 | Trial to Determine the ... Study PTM-001-01 is a 12-week, randomized, placebo controlled, double blind study with a 12 week open-label extension to examine the immunomodulatory activity ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10307738/

The Current Clinical Trial Landscape for Hidradenitis ... Trial to determine the immunomodulatory activity of PTM-001 in patients with hidradenitis suppurativa. ClinicalTrial.gov Identifier ...

3. academic.oup.com academic.oup.com/bjd/article/190/2/149/7275339

Hidradenitis suppurativa: new insights into disease ... Trial to determine the immunomodulatory activity of PTM-001 in patients with hidradenitis suppurativa. Available at. : https://clinicaltrials.gov/ct2/show ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10366071/

Emerging Treatments and the Clinical Trial Landscape for ... Hidradenitis suppurativa (HS) is a chronic, autoinflammatory condition that causes a severe impact on patients' quality of life. The cause of HS is still under ...

5. withpower.com withpower.com/trial/phase-3-hidradenitis-8-2021-29b3e

PTM-001 for Hidradenitis Suppurativa · Info for Participants 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 ...

6. springermedizin.de springermedizin.de/the-current-clinical-trial-landscape-for-hidradenitis-suppurativ/25434584

The Current Clinical Trial Landscape for Hidradenitis ... This review discusses current clinical trials for biologics and small molecules, procedures, and wound dressings undergoing study in hidradenitis suppurativa.