Participants with Mild to Moderate Hidradenitis Suppurativa Will Receive EVO101 a Topical Cream 0.1%

NCT06645821 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: EVO101-HS001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Keywords

EVO101; Hidradenitis Suppurativa; topical cream; Acne inversa

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 Weeks

Study Arms (1)

Open label EVO101 topical cream 0.1%

EXPERIMENTAL

All eligible subjects will receive open label EVO101 topical cream 0.1%

Drug: EVO101

Interventions

EVO101 DRUG

EVO101 topical cream 0.1%

Open label EVO101 topical cream 0.1%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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:
• \< 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

Sponsors & Collaborators

• Virginia Clinical Research, Inc.: lead
• Evommune, Inc.: collaborator

Study Sites (1)

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

David M Pariser, MD

CONTACT

757-625-0151; dpariser@pariserderm.com

Danielle L Benedict

CONTACT

757-625-0151; dbenedict@vcrinc.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 17, 2024
• Study Start: December 3, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

US (1)