PTM-001 for Hidradenitis Suppurativa

Recruiting at 2 trial locations

Overseen By Ramsey Johnson, MSM

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Phoenicis Therapeutics

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+