Hidradenitis SuppurativaPhase 2NCT05020730
Trial to Determine the Immunomodulatory Activity of PTM-001 in Patients With Hidradenitis Suppurativa
A Phase 2 study testing PTM-001 in people with Hidradenitis Suppurativa, run by Phoenicis Therapeutics at 3 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- PTM-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 May 2022to Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Phoenicis Investigative Site
Cincinnati, Ohio, 45229
(978) 726-1478
- Recruiting
Phoenicis Investigative Site
Redwood City, California, 94063
(978) 726-1478
- Recruiting
Phoenicis Investigative Site
Worcester, Massachusetts, 01655
(978) 726-1478
About this study
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 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- PTM-001, Placebo
- Keywords
- Hidradenitis Suppurativa, HS, Inflammatory skin disease, Humira, P2X7, IL-1β
- Medical subject headings
- Hidradenitis Suppurativa, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTM-001Drug
PTM-001 (400 mg) every day for 12 weeks
PlaceboDrug
Matching placebo every day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| PTM-001 400 mg daily for 12 weeks | Experimental | Not described Receives: Drug: PTM-001 |
| Placebo daily for 12 weeks | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of PTM-001 on IL-1β protein levels in lesional skin biopsies
Measured: Baseline to Week 12
Secondary outcomes (12)
Demonstrate a change in IL-1⍺, IL-23p19, IL-17A, IL-5, IL-6, TNF⍺, HBD-2 protein levels in lesional skin biopsies
Measured: 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
Measured: 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
Measured: Baseline to Week 12
Demonstrate a change in serum amyloid A levels
Measured: Baseline to Week 12
Change in Pain, as measured using a 10-point numerical rating scale, 1 through 10, with 10 being the worst.
Measured: Baseline to Week 12
Change in Quality of Life using Dermatology Life Quality Index (DLQI)
Measured: Baseline to Week 12
Change in clinical status using the Hurley Staging
Measured: Baseline to Week 12
Change in clinical status using the International Hidradenitis Suppurative Severity Score System (IHS4)
Measured: Baseline to Week 12
Change in clinical status using the Hidradenitis Suppurative Clinical Response (HiSCR)
Measured: Baseline to Week 12
Change in clinical status using the Hidradenitis Suppurative Physician Global Assessment (HS-PGA)
Measured: Baseline to Week 12
Change in clinical status using the Hidradenitis Suppurative Area and Severity Index-Revised (HASI-R)
Measured: Baseline to Week 12
Change in abscesses and inflammatory nodules count (AN count)
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start5 May 2022
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phoenicis Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020730
- Sponsor's protocol ID
- PTM-001-01
- Status last verified
- Oct 2022
- First submitted
- 18 Aug 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05020730
- Acronym / sponsor ID
- PTM-001-01
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, HS, Inflammatory skin disease, Humira, P2X7, IL-1β
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Phoenicis TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 5 May 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| PTM-001 400 mg daily for 12 weeks | Experimental | Drug: PTM-001 |
| Placebo daily for 12 weeks | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTM-001PTM-001 (400 mg) every day for 12 weeks | Drug | PTM-001 400 mg daily for 12 weeks |
| PlaceboMatching placebo every day for 12 weeks | Drug | Placebo daily for 12 weeks |
Primary outcome
Effect of PTM-001 on IL-1β protein levels in lesional skin biopsies
Time frame: Baseline to Week 12
12 secondary outcomes
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
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
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
Demonstrate a change in serum amyloid A levels
Time frame: Baseline to Week 12
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
Change in Quality of Life using Dermatology Life Quality Index (DLQI)
Time frame: Baseline to Week 12
Change in clinical status using the Hurley Staging
Time frame: Baseline to Week 12
Change in clinical status using the International Hidradenitis Suppurative Severity Score System (IHS4)
Time frame: Baseline to Week 12
Change in clinical status using the Hidradenitis Suppurative Clinical Response (HiSCR)
Time frame: Baseline to Week 12
Change in clinical status using the Hidradenitis Suppurative Physician Global Assessment (HS-PGA)
Time frame: Baseline to Week 12
Change in clinical status using the Hidradenitis Suppurative Area and Severity Index-Revised (HASI-R)
Time frame: Baseline to Week 12
Change in abscesses and inflammatory nodules count (AN count)
Time frame: Baseline to Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PTM-001 in people with Hidradenitis Suppurativa, run by Phoenicis Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramsey Johnson, MSM (978-726-1478, ramsey@phoenicistx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of PTM-001 on IL-1β protein levels in lesional skin biopsies (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.