Hidradenitis Suppurativa (HS)Early Phase 1NCT06645821
Participants with Mild to Moderate Hidradenitis Suppurativa Will Receive EVO101 a Topical Cream 0.1%
A Early Phase 1 study testing EVO101 in people with Hidradenitis Suppurativa (HS), run by Virginia Clinical Research, Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if drug EVO101 works to treat mild to moderate hidradenitis suppurativa in adults. The main questions it aims to answer are: Does drug EVO101 lower the total number of lesion a participant has from the first visit to the last visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- EVO101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2024to May 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Ability to comprehend and willingness to sign a written informed consent form (ICF) for the study.
- Age ≥ 18 years at the time of signing the ICF (informed consent).
- Diagnosis of hidradenitis suppurativa (HS) for at least 3 months prior to the screening visit.
- Mild to moderate HS (hidradenitis suppurativa) at the Baseline Visit (using the HS-PGA/Hidradenitis Suppurativa Physician's Global Assessment scale ).
- Total hidradenitis suppurativa lesion count (abscess, fistulas, nodules, papules, and/or pustules) of at least 5 at the baseline visit.
- Agreement to NOT use topical and/or systemic antibiotics for treatment of HS (hidradenitis suppurativa) for the duration of the study.
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- Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide. Note: Over-the-counter non-medicated soap and water is allowed.
- For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 30 days after the last application of study drug.
- A woman of childbearing potential is defined as a postmenarcheal female, who has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause) and has not undergone surgical sterilization (removal of ovaries and/or uterus).
- The following are highly effective contraceptive methods: combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation, progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, or sexual abstinence. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception. Females must agree not to donate ova during the study and for 30 days after the end of study visit.
- Willing and able to comply with the study protocol and procedures.
Who cannot join
- Very severe, severe, minimal, or clear hidradenitis suppurativa Hidradenitis Suppurativa Physician's Global Assessment scale (HS-PGA).
- Women who are pregnant (or who are considering pregnancy) or breastfeeding.
- Subject has uncontrolled, clinically significant comorbidities that make them unsuitable for the clinical trial in the opinion of the investigator.
- Have undergone significant trauma or major surgery (per investigator's assessment) within 30 days preceding the screening visit.
- History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months preceding the screening visit.
- Use of any of the following medications or treatments within the specified time periods prior to the baseline visit:
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- < 12 weeks or 5 half-lives (whichever is longer)
- Investigational or experimental treatments.
- Immunomodulating biologic drugs
- < 4 weeks
- Systemic JAK inhibitors.
- Systemic immunosuppressive or immunomodulating small-molecule drugs (eg, corticosteroids [oral or intravenous], avacopan, IRAK4 inhibitors, methotrexate, cyclosporine, dapsone, azathioprine).
- Surgical, laser, or any phototherapy intervention in areas with HS lesions
- < 2 weeks
- Other systemic therapies for HS
- Retinoids, antihyperglycemics, and antiandrogens, such as acitretin, isotretinoin, metformin, spironolactone, and finasteride) with potential therapeutic impact unless the subject is on a stable dose as defined by the investigator for at least 28 days. There should be no anticipated change of these medications while the subject is on the study.
- Systemic anti-infectives for HS
- Antibiotics, antivirals, antifungals
- <1 week
- Oral or topical PDE4 inhibitor (e.g., apremilast, crisaborole)
- Topical JAK inhibitor
- Topical anti-infectives for HS lesions
- o Antibiotics, antivirals, antifungals
- Topical products containing chlorhexidine gluconate, benzoyl peroxide, or topical diluted bleach bath to treat HS. Note: Non-medicated over-the-counter soap and water are not restricted.
- Any topical drug applied onto HS lesions
- Topical or intralesional corticosteroids o Note: Use of topical corticosteroids for dermatologic diseases other than HS (Hidradenitis Suppurativa)(e.g., atopic dermatitis, psoriasis) is allowed for areas not being treated for HS (Hidradenitis Suppurativa)as long as it is not within 10cm of the areas affected by HS (Hidradenitis Suppurativa).
- Inhaled corticosteroids are allowed.
- Active participation in an experimental therapy study or who received experimental therapy within 30 days or 5 half-lives (whichever is longer) before Baseline.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Danielle Benedict, 7576250151 ext. 1000, dbenedict@vcrinc.org
Erin Rivera, 757-625-0151 ext. 1005, erivera@vcrinc.org
About this study
Official title: Open-label, Investigator-initiated, Single-site Proof of Concept Trial Evaluating EVO101 in Adult Subjects with Mild to Moderate Hidradenitis Suppurativa.
The goal of this clinical trial is to learn if drug EVO101 works to treat mild to moderate hidradenitis suppurativa in adults. The main questions it aims to answer are:
Does drug EVO101 lower the total number of lesion a participant has from the first visit to the last visit.
Read more
What medical problems do participants have when applying drug EVO101 Does a participant perceive a change in their hidradenitis suppurativa symptoms based on patient reported outcome questionnaires.
Participants will:
Apply EVO101 topical cream 0.1% topically Visit the clinic four times unless the first and second appointment have to be done separately then there will be five clinic visits and one phone call over a twelve week period.
Keep a dosing diary
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- EVO101
- Keywords
- EVO101, Hidradenitis Suppurativa, topical cream, Acne inversa
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVO101Drug
EVO101 topical cream 0.1%
| Study group | Role | What they receive |
|---|---|---|
| Open label EVO101 topical cream 0.1% | Experimental | All eligible subjects will receive open label EVO101 topical cream 0.1% Receives: Drug: EVO101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of EVO101 on hidradenitis suppurativa will be evaluated using two parameters: decrease in lesion count and change in patient reported outcomes (PRO)
The change in the total HS lesion count will be assessed at Week 4, Week 8, and Week 12. The percent change from Baseline will be calculated.
Measured: 12 Weeks
The efficacy of EVO101 on hidradenitis suppurativa will be evaluated using two parameters: decrease in lesion count and change in patient reported outcomes (PRO)
PRO's will be completed to evaluate whether the subjects perceive a change in their HS symptoms. PRO's will include the DLQI, NRS Scale of Pain, and Patient Impression of Severity. Efficacy will be calculated by the percent change in each PRO from Baseline at Week 4, Week 8, and Week 12.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start3 Dec 2024
- Primary completionMar 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Clinical Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Evommune, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645821
- Sponsor's protocol ID
- EVO101-HS001
- Status last verified
- Dec 2024
- First submitted
- 11 Oct 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Lesion count and PRO data
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Investigator-initiated, Single-site Proof of Concept Trial Evaluating EVO101 in Adult Subjects with Mild to Moderate Hidradenitis Suppurativa.
- ClinicalTrials.gov ID
- NCT06645821
- Acronym / sponsor ID
- EVO101-HS001
- Conditions
- Hidradenitis Suppurativa (HS)
- Keywords
- EVO101, Hidradenitis Suppurativa, topical cream, Acne inversa
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Virginia Clinical Research, Inc.University, hospital or other
- Collaborators
- Evommune, Inc.
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 17 Oct 2024 (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.
The goal of this clinical trial is to learn if drug EVO101 works to treat mild to moderate hidradenitis suppurativa in adults. The main questions it aims to answer are:
Does drug EVO101 lower the total number of lesion a participant has from the first visit to the last visit.
What medical problems do participants have when applying drug EVO101 Does a participant perceive a change in their hidradenitis suppurativa symptoms based on patient reported outcome questionnaires.
Participants will:
Apply EVO101 topical cream 0.1% topically Visit the clinic four times unless the first and second appointment have to be done separately then there will be five clinic visits and one phone call over a twelve week period.
Keep a dosing diary
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label EVO101 topical cream 0.1% | Experimental | Drug: EVO101All eligible subjects will receive open label EVO101 topical cream 0.1% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to comprehend and willingness to sign a written informed consent form (ICF) for the study.
- Age ≥ 18 years at the time of signing the ICF (informed consent).
- Diagnosis of hidradenitis suppurativa (HS) for at least 3 months prior to the screening visit.
- Mild to moderate HS (hidradenitis suppurativa) at the Baseline Visit (using the HS-PGA/Hidradenitis Suppurativa Physician's Global Assessment scale ).
- Total hidradenitis suppurativa lesion count (abscess, fistulas, nodules, papules, and/or pustules) of at least 5 at the baseline visit.
Key exclusion criteria (28 listed)
- Very severe, severe, minimal, or clear hidradenitis suppurativa Hidradenitis Suppurativa Physician's Global Assessment scale (HS-PGA).
- Women who are pregnant (or who are considering pregnancy) or breastfeeding.
- Subject has uncontrolled, clinically significant comorbidities that make them unsuitable for the clinical trial in the opinion of the investigator.
- Have undergone significant trauma or major surgery (per investigator's assessment) within 30 days preceding the screening visit.
- History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months preceding the screening visit.
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 |
|---|---|---|
| EVO101EVO101 topical cream 0.1% | Drug | Open label EVO101 topical cream 0.1% |
Primary outcome
The efficacy of EVO101 on hidradenitis suppurativa will be evaluated using two parameters: decrease in lesion count and change in patient reported outcomes (PRO)
Time frame: 12 Weeks
The change in the total HS lesion count will be assessed at Week 4, Week 8, and Week 12. The percent change from Baseline will be calculated.
The efficacy of EVO101 on hidradenitis suppurativa will be evaluated using two parameters: decrease in lesion count and change in patient reported outcomes (PRO)
Time frame: 12 Weeks
PRO's will be completed to evaluate whether the subjects perceive a change in their HS symptoms. PRO's will include the DLQI, NRS Scale of Pain, and Patient Impression of Severity. Efficacy will be calculated by the percent change in each PRO from Baseline at Week 4, Week 8, and Week 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: Yes. Lesion count and PRO data
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing EVO101 in people with Hidradenitis Suppurativa (HS), run by Virginia Clinical Research, Inc. at 1 site 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 11 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David M Pariser, MD (757-625-0151, dpariser@pariserderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of EVO101 on hidradenitis suppurativa will be evaluated using two parameters: decrease in lesion count and change in patient reported outcomes (PRO) (time frame: 12 Weeks). The study lists 2 primary outcomes in all. 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 11 Dec 2024.