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

Hidradenitis Suppurativa Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05020730
• Other study ID #: PTM-001-01
• Status: Recruiting
• Phase: Phase 2
• Start date: May 5, 2022
• Est. completion date: June 2024

Study information

• Verified date: October 2022
• Source: Phoenicis Therapeutics
• Contact: Ramsey Johnson, MSM
• Phone: 978-726-1478
• Email: ramsey[@]phoenicistx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• PTM-001
PTM-001 (400 mg) every day for 12 weeks
• Placebo
Matching placebo every day for 12 weeks

Locations

Country	Name	City	State
United States	Phoenicis Investigative Site	Cincinnati	Ohio
United States	Phoenicis Investigative Site	Redwood City	California
United States	Phoenicis Investigative Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Phoenicis Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of PTM-001 on IL-1ß protein levels in lesional skin biopsies		Baseline to Week 12
Secondary	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
Secondary	Demonstrate a change in IL-1ß, IL-1?, IL-23p19, IL-17A, IL-5, IL-6, TNF?, HBD-2 mRNA expression in lesional skin biopsies		Baseline to Week 12
Secondary	Demonstrate a change in IL-1ß, IL-1?, IL-23p19, IL-17A, IL-5, IL-6, TNF?, HBD-2 protein levels in serum		Baseline to Week 12
Secondary	Demonstrate a change in serum amyloid A levels		Baseline to Week 12
Secondary	Change in Pain, as measured using a 10-point numerical rating scale, 1 through 10, with 10 being the worst.		Baseline to Week 12
Secondary	Change in Quality of Life using Dermatology Life Quality Index (DLQI)		Baseline to Week 12
Secondary	Change in clinical status using the Hurley Staging		Baseline to Week 12
Secondary	Change in clinical status using the International Hidradenitis Suppurative Severity Score System (IHS4)		Baseline to Week 12
Secondary	Change in clinical status using the Hidradenitis Suppurative Clinical Response (HiSCR)		Baseline to Week 12
Secondary	Change in clinical status using the Hidradenitis Suppurative Physician Global Assessment (HS-PGA)		Baseline to Week 12
Secondary	Change in clinical status using the Hidradenitis Suppurative Area and Severity Index-Revised (HASI-R)		Baseline to Week 12
Secondary	Change in abscesses and inflammatory nodules count (AN count)		Baseline to Week 12