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

• ClinicalTrials.gov Identifier: NCT05020730
• Recruitment Status: Not yet recruiting
• First Posted: August 25, 2021
• Last Update Posted: May 16, 2022
• Sponsor: Phoenicis Therapeutics
• Information provided by (Responsible Party): Phoenicis Therapeutics

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 (Clinical Trial)
• Estimated 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 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
• Estimated Study Start Date: September 2022
• Estimated Primary Completion Date: September 2022
• Estimated Study Completion Date: November 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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Ramsey Johnson, MSM; 978-726-1478; ramsey@phoenicistx.com

Sponsors and Collaborators

Phoenicis Therapeutics

More Information

• Responsible Party: Phoenicis Therapeutics
• ClinicalTrials.gov Identifier: NCT05020730
• Other Study ID Numbers: PTM-001-01
• First Posted: August 25, 2021
• Last Update Posted: May 16, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Phoenicis Therapeutics:

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

Additional relevant MeSH terms:

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