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

NCT05020730 | Unknown Phase 2 FDA Drug

• 1 other identifier: PTM-001-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa; HS; Inflammatory skin disease; Humira; P2X7; IL-1β

Outcome Measures

Primary Outcomes (1)

• Effect of PTM-001 on IL-1β protein levels in lesional skin biopsies

  Baseline to Week 12

Secondary Outcomes (12)

• 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

Study Arms (2)

PTM-001 400 mg daily for 12 weeks

EXPERIMENTAL

Drug: PTM-001

Placebo daily for 12 weeks

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PTM-001 DRUG

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

PTM-001 400 mg daily for 12 weeks

Placebo DRUG

Matching placebo every day for 12 weeks

Placebo daily for 12 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Phoenicis Therapeutics: lead

Study Sites (3)

Phoenicis Investigative Site

Redwood City, California, 94063, United States

RECRUITING

Phoenicis Investigative Site

Worcester, Massachusetts, 01655, United States

RECRUITING

Phoenicis Investigative Site

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa; Dermatitis

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

Ramsey Johnson, MSM

CONTACT

978-726-1478; ramsey@phoenicistx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 25, 2021
• Study Start: May 5, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)