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

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

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

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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

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05020730


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

Sponsors and Collaborators
Phoenicis Therapeutics
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Responsible Party: Phoenicis Therapeutics
ClinicalTrials.gov Identifier: NCT05020730    
Other Study ID Numbers: PTM-001-01
First Posted: August 25, 2021    Key Record Dates
Last Update Posted: May 16, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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