EVO101 Cream for Hidradenitis Suppurativa

Overseen By Danielle L Benedict

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Virginia Clinical Research, Inc.

Must not be taking: Biologics, JAK inhibitors

Disqualifiers: Severe HS, Pregnancy, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether EVO101 cream can reduce the number of skin lesions in individuals with mild to moderate hidradenitis suppurativa, a long-term skin condition that causes painful bumps. Researchers also seek to determine if patients notice symptom improvement and if any side effects arise from using the cream. Participants will apply the cream, maintain a dosing diary, and visit the clinic several times over 12 weeks. The trial seeks individuals who have had hidradenitis suppurativa for at least three months and experience at least five lesions. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

You may need to stop certain medications before joining the trial. Specifically, you cannot use antibiotics, certain topical treatments, or systemic therapies for hidradenitis suppurativa during the study. Some medications require a 'washout' period (time without taking them) before starting the trial.

Is there any evidence suggesting that EVO101 cream is likely to be safe for humans?

Research shows that EVO101 cream is being tested for safety and effectiveness in treating skin conditions. Previous studies on atopic dermatitis evaluated EVO101 for safety, and no major safety issues emerged, indicating that the treatment is generally well-tolerated.

As this trial is in the early stages, it primarily focuses on assessing the cream's safety for people. While some evidence suggests EVO101 might be safe, it is still under close observation to ensure no unexpected side effects occur. Participants in this trial will provide more information on how well people tolerate the cream when used for hidradenitis suppurativa, a condition that causes painful skin sores. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for hidradenitis suppurativa, which typically include antibiotics, anti-inflammatory drugs, or biologics, EVO101 cream offers a new approach with its topical delivery method. EVO101 is unique because it is applied directly to the skin, targeting the affected areas more precisely, which may reduce systemic side effects. Researchers are excited about EVO101 because it could provide a more localized and potentially safer treatment option for patients, especially those who may not tolerate systemic medications well. Additionally, the cream's formulation could lead to faster relief of symptoms, providing a more convenient and user-friendly option for managing this challenging condition.

What evidence suggests that EVO101 cream might be an effective treatment for hidradenitis suppurativa?

Researchers are investigating EVO101 cream as a potential treatment for mild to moderate hidradenitis suppurativa, a skin condition that causes painful lumps. In this trial, all eligible participants will receive open-label EVO101 topical cream 0.1%. The trial measures the cream's success by its ability to reduce the number of skin bumps and improve patient-reported symptoms. Although specific information for hidradenitis suppurativa is limited, EVO101 is also undergoing tests for other skin conditions, which is promising. The cream may help reduce inflammation, a major issue in many skin problems. Early results suggest it could be helpful, but further research is needed to confirm its effectiveness for this condition. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults with mild to moderate hidradenitis suppurativa, a skin condition that causes small, painful lumps under the skin. Participants must be willing to apply a topical cream, visit the clinic up to five times, and keep a dosing diary over twelve weeks.

Inclusion Criteria

For women of childbearing potential: agree to remain abstinent or use a highly effective contraceptive method during the treatment period and for at least 30 days after the last application of study drug

I have been diagnosed with hidradenitis suppurativa for at least 3 months.

My HS condition is rated as mild to moderate.

Exclusion Criteria

I am not pregnant or breastfeeding.

I haven't taken certain medications or treatments recently.

Very severe, severe, minimal, or clear HS-PGA

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply EVO101 topical cream 0.1% and visit the clinic four to five times over a twelve-week period

12 weeks

4-5 visits (in-person), 1 phone call

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EVO101

Trial Overview

The trial is testing EVO101 topical cream (0.1%) for treating hidradenitis suppurativa. It aims to see if this treatment reduces the number of lesions from first to last visit and improves symptoms based on patient questionnaires.

How Is the Trial Designed?

Group I: Open label EVO101 topical cream 0.1% Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Virginia Clinical Research, Inc.

Lead Sponsor

Trials

5

Recruited

160+

Evommune, Inc.

Industry Sponsor

Trials

5

Recruited

380+

Published Research Related to This Trial

In a study involving 40 children aged 5 to 11, alclometasone dipropionate cream 0.05% was found to be slightly more effective than hydrocortisone butyrate cream 0.1% in treating atopic dermatitis, with an average improvement of 76% compared to 70%.

At the end of the 2-week treatment, 19 out of 20 children using alclometasone showed significant improvement in their symptoms, while 16 out of 20 children using hydrocortisone did, indicating that both treatments are effective but alclometasone may offer better results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical comparison of alclometasone dipropionate cream 0.05% with hydrocortisone butyrate cream 0.1% in the treatment of atopic dermatitis in children. Lassus, A.[2017]

In a study of 331 patients with tinea cruris or tinea corporis, SCH 370 cream (1% clotrimazole/0.05% betamethasone dipropionate) showed faster therapeutic activity and better clinical results compared to clotrimazole or betamethasone alone, particularly after one week of treatment.

All treatments were found to be safe, with no unexpected or serious adverse effects reported, indicating that SCH 370 cream is a well-tolerated option for treating these fungal infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SCH 370 (clotrimazole-betamethasone dipropionate) cream in patients with tinea cruris or tinea corporis. Katz, HI., Bard, J., Cole, GW., et al.[2014]

In a 6-week study involving 75 participants with moderate to severe seborrheic dermatitis, the new EDS cream significantly reduced the severity of symptoms, with an 88% improvement in the Investigator Global Assessment score by week 6.

The treatment not only alleviated skin symptoms but also positively influenced the skin microbiota, increasing beneficial Cutibacterium acnes while decreasing harmful Staphylococcus, indicating a rebalancing effect on the skin's microbial environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a cream containing 5% hyaluronic acid mixed with a bacterial-wall-derived glycoprotein, glycyrretinic acid, piroctone olamine and climbazole on signs, symptoms and skin bacterial microbiota in subjects with seborrheic dermatitis of the face. Puviani, M., Campione, E., Offidani, AM., et al.[2020]

In a phase II study involving 20 patients with mild to moderate atopic eczema, both the new mometasone furoate cream (Monovo®) and the existing fatty cream (Ecural®) were found to be equally effective and well tolerated.

Patients preferred the new formulation due to its improved cosmetic properties, suggesting that while both treatments are effective, the new cream may enhance patient satisfaction and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and patient-reported outcomes of a new mometasone cream treating atopic eczema. Ruzicka, T., Willers, C., Wigger-Alberti, W.[2015]

The developed aspasomal gel of Mometasone Furoate showed a sustained drug release over 24 hours, significantly longer than the 5 hours observed with the marketed cream, indicating improved efficacy in treating psoriasis.

In vivo studies on Wistar rats demonstrated that the aspasomal gel did not cause skin irritation or inflammation, suggesting a safe delivery system for the treatment of psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mometasone furoate-loaded aspasomal gel for topical treatment of psoriasis: formulation, optimization, in&#160;vitro and in&#160;vivo performance. Shinde, G., Desai, P., Shelke, S., et al.[2022]

Citations

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clinicaltrials.gov/study/NCT06645821

Study Details | NCT06645821 | Participants with Mild to ...

The efficacy of EVO101 on hidradenitis suppurativa will be evaluated using two parameters: decrease in lesion count and change in patient reported outcomes (PRO) ...

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centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06645821/participants-with-mild-to-moderate-hidradenitis-suppurativa-will-receive-evo101-a-topical-cream-01?page=8&id=1&slug=acne

Participants with Mild to Moderate Hidradenitis Suppurativa ...

Study Summary. The goal of this clinical trial is to learn if drug EVO101 works to treat mild to moderate hidradenitis suppurativa in adults.

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EVO-101 - Drug Targets, Indications, Patents

The once-daily oral drug is being explored for chronic inducible urticaria, chronic spontaneous urticaria, atopic dermatitis and other indications.

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EVO101 / Evommune, Eli Lilly - Dermatology

Participants with Mild to Moderate Hidradenitis Suppurativa Will Receive EVO101 a Topical Cream 0.1% ... - "Separately, following a review of results from its ...

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Hidradenitis Suppurativa (HS) (DBCOND0054533)

A Randomized Controlled Trial Evaluating the Efficacy of Intralesional Triamcinolone in Hidradenitis Suppurativa. Triamcinolone. treatment, Not Available ...

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Hidradenitis Suppurativa Clinical Research Trials

Participants with Mild to Moderate Hidradenitis Suppurativa Will Receive EVO101 a Topical Cream 0.1% ... The study evaluates the safety and effects of a ...

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A Living Systematic Review and Network Meta-Analysis

This network meta-analysis provides evidence for the comparative efficacy and safety of currently approved and pipeline medications for moderate to severe HS