Trial to Determine the Immunomodulatory Activity of PTM-001 in Patients With Hidradenitis Suppurativa

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-05

Study Completion Date

2024-06-30

Brief Summary

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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 of PTM-001 in participants with Hidradenitis Suppurativa (HS). Participants will be randomized to receive PTM-001 (400 mg) or matching placebo every day for 12 weeks after which all participants will receive open-label PTM-001 400 mg daily for an additional 12 weeks. Randomization will be stratified by Hurley Stage.

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Detailed Description

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Conditions

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Hidradenitis Suppurativa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized to receive PTM-001 (400 mg) or matching placebo every day for 12 weeks after which all patients will receive open-label PTM-001 400 mg daily for an additional 12 weeks

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PTM-001 400 mg daily for 12 weeks

Group Type EXPERIMENTAL

PTM-001

Intervention Type DRUG

PTM-001 (400 mg) every day for 12 weeks

Placebo daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo every day for 12 weeks

Interventions

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PTM-001

PTM-001 (400 mg) every day for 12 weeks

Intervention Type DRUG

Placebo

Matching placebo every day for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Had onset of symptoms consistent with HS at least 6 months prior to Screening.
* Has had active HS for at least 2 months.
* 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.
* Agrees to use contraception

Exclusion Criteria

* Has other skin disease or condition that can interfere with HS assessment.
* Has a positive test for TB, HIV, hepatitis B and/or hepatitis C at Screening.
* Has a history of retinopathy or known clinically significant cardiovascular or hematologic conditions.
* Has taken any biologic drug within 3 serum half-lives. A list of potential biologics and their half-lives
* Has started oral antibiotics within 28 days of Study Day 1.
* Has, within 2 weeks prior to Day 1, received a medication prohibited based on cytochrome P450 (CYP3A4) interaction
* Has such extensive disease that, in the opinion of the Investigator, it is difficult to discriminate between active lesions and scarring.
* Has more than 15 active tunnels at Screening.
* Is pregnant, nursing or considering becoming pregnant.
* Has a history of malignancy except non-melanoma skin cancer or cervical carcinoma in situ.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No