Back to resultsTrial to Determine the Immunomodulatory Activity of PTM-001 in Patients With Hidradenitis Suppurativa
Primary Purpose
Hidradenitis Suppurativa
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PTM-001
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis Suppurativa, HS, Inflammatory skin disease, Humira, P2X7, IL-1β
Eligibility 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.
Sites / Locations
- Phoenicis Investigative SiteRecruiting
- Phoenicis Investigative SiteRecruiting
- Phoenicis Investigative SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PTM-001 400 mg daily for 12 weeks
Placebo daily for 12 weeks
Arm Description
Outcomes
Primary Outcome Measures
Effect of PTM-001 on IL-1β protein levels in lesional skin biopsies
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
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
Demonstrate a change in IL-1β, IL-1⍺, IL-23p19, IL-17A, IL-5, IL-6, TNF⍺, HBD-2 protein levels in serum
Demonstrate a change in serum amyloid A levels
Change in Pain, as measured using a 10-point numerical rating scale, 1 through 10, with 10 being the worst.
Change in Quality of Life using Dermatology Life Quality Index (DLQI)
Change in clinical status using the Hurley Staging
Change in clinical status using the International Hidradenitis Suppurative Severity Score System (IHS4)
Change in clinical status using the Hidradenitis Suppurative Clinical Response (HiSCR)
Change in clinical status using the Hidradenitis Suppurative Physician Global Assessment (HS-PGA)
Change in clinical status using the Hidradenitis Suppurative Area and Severity Index-Revised (HASI-R)
Change in abscesses and inflammatory nodules count (AN count)
Full Information
NCT ID
NCT05020730
First Posted
August 18, 2021
Last Updated
October 24, 2022
Sponsor
Phoenicis Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT05020730
Brief Title
Trial to Determine the Immunomodulatory Activity of PTM-001 in Patients With Hidradenitis Suppurativa
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phoenicis Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Hidradenitis Suppurativa, HS, Inflammatory skin disease, Humira, P2X7, IL-1β
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PTM-001 400 mg daily for 12 weeks
Arm Type
Experimental
Arm Title
Placebo daily for 12 weeks
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PTM-001
Intervention Description
PTM-001 (400 mg) every day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo every day for 12 weeks
Primary Outcome Measure Information:
Title
Effect of PTM-001 on IL-1β protein levels in lesional skin biopsies
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Demonstrate a change in serum amyloid A levels
Time Frame
Baseline to Week 12
Title
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
Title
Change in Quality of Life using Dermatology Life Quality Index (DLQI)
Time Frame
Baseline to Week 12
Title
Change in clinical status using the Hurley Staging
Time Frame
Baseline to Week 12
Title
Change in clinical status using the International Hidradenitis Suppurative Severity Score System (IHS4)
Time Frame
Baseline to Week 12
Title
Change in clinical status using the Hidradenitis Suppurative Clinical Response (HiSCR)
Time Frame
Baseline to Week 12
Title
Change in clinical status using the Hidradenitis Suppurative Physician Global Assessment (HS-PGA)
Time Frame
Baseline to Week 12
Title
Change in clinical status using the Hidradenitis Suppurative Area and Severity Index-Revised (HASI-R)
Time Frame
Baseline to Week 12
Title
Change in abscesses and inflammatory nodules count (AN count)
Time Frame
Baseline to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramsey Johnson, MSM
Phone
978-726-1478
Email
ramsey@phoenicistx.com
Facility Information:
Facility Name
Phoenicis Investigative Site
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
(978) 726-1478
Facility Name
Phoenicis Investigative Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
(978) 726-1478
Facility Name
Phoenicis Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
(978) 726-1478
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trial to Determine the Immunomodulatory Activity of PTM-001 in Patients With Hidradenitis Suppurativa
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