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Live Biotherapeutic Product

Topical ENS-002 for Eczema (EnSync Trial)

Phase 1

Recruiting

Research Sponsored by Concerto Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older on the day of signing the ICF

Diagnosis of AD according to Hanifin and Rajka

Must not have

Unwilling to stop hair removal in ENS-002 administration body sites

Clinically significant cardiovascular, liver, pulmonary, neurologic, metabolic, or kidney disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 43 days

Awards & highlights

Summary

This trial aims to test the safety and impact of ENS-002, a live bacteria product, on individuals with atopic dermatitis.

Who is the study for?

This trial is for adults with atopic dermatitis, commonly known as eczema. Participants should have a diagnosis of this skin condition to qualify.

What is being tested?

The study is testing ENS-002, which is a live biotherapeutic product containing three types of good bacteria. It aims to assess the safety and effects on those with atopic dermatitis.

What are the potential side effects?

Since specific side effects are not listed, they may include typical reactions associated with topical treatments such as redness, itching, or irritation at the site of application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with atopic dermatitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unwilling to stop hair removal at the treatment sites.

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I do not have serious heart, liver, lung, brain, metabolic, or kidney diseases.

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I am not currently on experimental drugs or Janus kinase inhibitors.

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My skin condition affects more than 20% of my body for Cohort 2, or more than 10% for Cohort 3.

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I have a history of heart valve disease or have a pacemaker or artificial valve.

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I cannot use at least 2 antibiotics effective against ENS-002 bacteria.

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I have had severe low white blood cell counts.

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I have a skin condition that affects my skin's protective barrier.

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I am taking medication that affects itching.

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I am currently using or have used treatments that affect my immune system, light therapy, or indoor tanning.

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I have not used any live bacterial products on my skin before starting ENS-002.

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I have never been treated with ENS-002.

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My eczema is severe.

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I have a skin condition that is not atopic dermatitis.

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I have significant skin breaks or cracks where the treatment would be applied.

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I have not had cancer in the last 3 years.

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I need to take medication that weakens my immune system.

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I have taken antibiotics in the last 21 days.

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I am a fertile man not using or willing to use strong birth control and won't donate sperm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 43 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 43 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 43 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recommended Phase 2 Dose (RP2D)

Safety of ENS-002 different dose durations

Safety of ENS-002 dose frequency

+4 more

Secondary outcome measures

Body Surface Area (BSA) absolute change

Body Surface Area (BSA) mean change

Changes in corticosteroid use by participants

+16 more

Other outcome measures

Changes in C-Reactive Protein (CRP) in peripheral blood

Changes in WBC subsets in peripheral blood

Changes in White Blood Count (WBC) in peripheral blood

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ENS-002Experimental Treatment1 Intervention

ENS-002 lotion to be applied topically either once or twice per day depending on assigned study cohort. Cohort 1 - once daily dose (QD) of low dose ENS-002. This dose will be applied topically to a single antecubital fossa target site once daily for 7 days. Cohort 2 - QD dose of high dose ENS-002. This dose will be applied topically to all affected skin (excluding scalp, face, groin, genitalia) once daily for 14 days. Cohort 3 - twice daily (BID) dose of high dose ENS-002 applied topically to all affected skin (excluding scalp, face, groin, genitalia) twice daily for 14 days

0 / 21Eligibility criteria met

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Who is running the clinical trial?

Concerto BiosciencesLead Sponsor

Bernardo Cervantes, PhDStudy ChairConcerto Biosciences

~6 spots leftby Dec 2024

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