Topical cream EVO101 for treating mild to moderate hidradenitis suppurativa

Open-label, Investigator-initiated, Single-site Proof of Concept Trial Evaluating EVO101 in Adult Subjects with Mild to Moderate Hidradenitis Suppurativa.

This study is testing a new cream called EVO101 to see if it can help adults with mild to moderate hidradenitis suppurativa feel better over twelve weeks.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Virginia Clinical Research, Inc. (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Norfolk, Virginia)
• Trial ID: NCT06645821 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of EVO101, a topical cream, in treating adults with mild to moderate hidradenitis suppurativa (HS). Participants will apply the cream and visit the clinic multiple times over a twelve-week period to assess changes in their HS symptoms and lesion counts. The study will also monitor any medical issues arising from the treatment and gather patient-reported outcomes. Participants will maintain a dosing diary to track their usage of the cream.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of mild to moderate hidradenitis suppurativa for at least three months.

Not a fit: Patients with severe hidradenitis suppurativa or those currently using antibiotics or antiseptic washes for treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the symptoms and lesions associated with hidradenitis suppurativa, improving patients' quality of life.

How similar studies have performed: While there have been studies on topical treatments for hidradenitis suppurativa, the specific use of EVO101 is novel and has not been extensively tested in prior research.

Eligibility criteria

Inclusion Criteria:

1. Ability to comprehend and willingness to sign a written informed consent form (ICF) for the study.
2. Age ≥ 18 years at the time of signing the ICF (informed consent).
3. Diagnosis of hidradenitis suppurativa (HS) for at least 3 months prior to the screening visit.
4. Mild to moderate HS (hidradenitis suppurativa) at the Baseline Visit (using the HS-PGA/Hidradenitis Suppurativa Physician's Global Assessment scale ).
5. Total hidradenitis suppurativa lesion count (abscess, fistulas, nodules, papules, and/or pustules) of at least 5 at the baseline visit.
6. Agreement to NOT use topical and/or systemic antibiotics for treatment of HS (hidradenitis suppurativa) for the duration of the study.
7. 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.
8. 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.
9. Willing and able to comply with the study protocol and procedures.

Exclusion Criteria:

1. Very severe, severe, minimal, or clear hidradenitis suppurativa Hidradenitis Suppurativa Physician's Global Assessment scale (HS-PGA).
2. Women who are pregnant (or who are considering pregnancy) or breastfeeding.
3. Subject has uncontrolled, clinically significant comorbidities that make them unsuitable for the clinical trial in the opinion of the investigator.
4. Have undergone significant trauma or major surgery (per investigator's assessment) within 30 days preceding the screening visit.
5. History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months preceding the screening visit.
6. Use of any of the following medications or treatments within the specified time periods prior to the baseline visit:

   1. \< 12 weeks or 5 half-lives (whichever is longer)

      * Investigational or experimental treatments.
      * Immunomodulating biologic drugs
   2. \< 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
   3. \< 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
   4. \<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.
7. Active participation in an experimental therapy study or who received experimental therapy within 30 days or 5 half-lives (whichever is longer) before Baseline.

Where this trial is running

Norfolk, Virginia

• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: David M Pariser, MD

Conditions Hidradenitis Suppurativa; EVO101; topical cream; Acne inversa