Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTM-001 400 mg daily for 12 weeks | Experimental |
| |
| Placebo daily for 12 weeks | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTM-001 | Drug | PTM-001 (400 mg) every day for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of PTM-001 on IL-1β protein levels in lesional skin biopsies | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ramsey Johnson, MSM | Contact | 978-726-1478 | ramsey@phoenicistx.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenicis Investigative Site | Recruiting | Redwood City | California | 94063 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
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
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Matching placebo every day for 12 weeks |
|
| 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 |
| Phoenicis Investigative Site | Recruiting | Worcester | Massachusetts | 01655 | United States |
|
| Phoenicis Investigative Site | Recruiting | Cincinnati | Ohio | 45229 | United States |
|
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |