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

Sponsor

Phoenicis Therapeutics (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05020730

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hidradenitis Suppurativa	Drug: PTM-001 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 weeksPatients 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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A 12-Week Double-Blind, Placebo-Controlled Randomized Phase 2 Trial With a 12-Week Open-Label Extension to Determine the Immunomodulatory Activity of PTM-001 in Patients With Hidradenitis Suppurativa

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PTM-001 400 mg daily for 12 weeks	Drug: PTM-001 PTM-001 (400 mg) every day for 12 weeks
Placebo Comparator: Placebo daily for 12 weeks	Drug: Placebo Matching placebo every day for 12 weeks

Arm

Intervention/Treatment

Experimental: PTM-001 400 mg daily for 12 weeks

Drug: PTM-001

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

Placebo Comparator: Placebo daily for 12 weeks

Drug: Placebo

Matching placebo every day for 12 weeks

Outcome Measures

Primary Outcome Measures

Effect of PTM-001 on IL-1β protein levels in lesional skin biopsies [Baseline to Week 12]

Secondary Outcome Measures

Demonstrate a change in IL-1⍺, IL-23p19, IL-17A, IL-5, IL-6, TNF⍺, HBD-2 protein levels in lesional skin biopsies [Baseline to Week 12]
Demonstrate a change in IL-1β, IL-1⍺, IL-23p19, IL-17A, IL-5, IL-6, TNF⍺, HBD-2 mRNA expression in lesional skin biopsies [Baseline to Week 12]
Demonstrate a change in IL-1β, IL-1⍺, IL-23p19, IL-17A, IL-5, IL-6, TNF⍺, HBD-2 protein levels in serum [Baseline to Week 12]
Demonstrate a change in serum amyloid A levels [Baseline to Week 12]
Change in Pain, as measured using a 10-point numerical rating scale, 1 through 10, with 10 being the worst. [Baseline to Week 12]
Change in Quality of Life using Dermatology Life Quality Index (DLQI) [Baseline to Week 12]
Change in clinical status using the Hurley Staging [Baseline to Week 12]
Change in clinical status using the International Hidradenitis Suppurative Severity Score System (IHS4) [Baseline to Week 12]
Change in clinical status using the Hidradenitis Suppurative Clinical Response (HiSCR) [Baseline to Week 12]
Change in clinical status using the Hidradenitis Suppurative Physician Global Assessment (HS-PGA) [Baseline to Week 12]
Change in clinical status using the Hidradenitis Suppurative Area and Severity Index-Revised (HASI-R) [Baseline to Week 12]
Change in abscesses and inflammatory nodules count (AN count) [Baseline to Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.