Atopic DermatitisPhase 1EnSyncNCT06469385
Topical ENS-002 for Atopic Dermatitis in Adults
A Phase 1 study testing ENS-002 in people with Atopic Dermatitis and Atopic Dermatitis Eczema, run by Concerto Biosciences at 3 sites in United States.
Trial summary
The goal of this study is to determine the safety and effects of ENS-002, a live biotherapeutic product (LBP) consisting of commensal, clonal, non-pathogenic bacteria in participants with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis, Atopic Dermatitis Eczema
- What is being tested?
- ENS-002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Sep 2024to 4 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Able to understand and sign an informed consent form (ICF).
- Age 18 years or older on the day of signing the ICF.
- Diagnosis of AD according to Hanifin and Rajka
- Atopic dermatitis has been diagnosed and present for ≥ 6 months prior to the first planned ENS-002 administration.
- EASI (Eczema Area and Severity Index) score of 5 to 7 (mild) or 7.1 to 21 (moderate), or ≥ 21.1 or severe at screening.
- Mild, moderate or severe AD as scored by the IGA at screening and baseline For Cohort 1, in which only a single antecubital fossa or other body site lesion will be administered ENS-002, a target lesion IGA will be performed.
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- Body surface area involvement must be ≥ 2% for mild AD and >10% for moderate to severe AD (excluding scalp, face, groin, and genitalia) at both screening and baseline as estimated based on the rule of nines and/or the palmar rule. Participants who have only one or a limited number of areas affected by AD (eg, neck, antecubital fossa, hands/feet, or popliteal involvement), as long as these sites have at least moderate severity, may also be eligible even if they do not meet the minimum BSA required - these participants will need to be approved by the Concerto Medical Monitor.
- Presence of specific bacteria via qPCR. Two affected skin sites will be sampled as part of the screening tests; if at least one of the affected skin sites contains the specified bacteria, the participant is eligible pending eligibility in all the other inclusion/exclusion criteria. If the qPCR test does not detect the specified bacteria, the participant is not eligible, but the bacteria skin swabs may be repeated. No more than 2 attempts to detect the specified bacterial colonization over 28 days may be made.
- Acceptable screening laboratory values that are within normal limits or are not clinically significantly abnormal. If clinical significance is unclear, the investigator must consult with Concerto's medical monitor.
- Complete blood count with WBC differential (including absolute values).
- Chemistry panel including hepatic transaminases.
- CRP.
- Urinalysis.
- 12-lead electrocardiogram.
- For women of childbearing potential (WOCBP), serum and/or urine test consistent with a non-pregnant state.
- If using an oral and/or topical H1 antihistamine for pruritus and/or insomnia, must have been on a stable dose and frequency for at least 14 days prior to screening and must continue at the same dose and frequency throughout the study.
- Willing and able to complete once-daily electronic diary entries for the duration of the study.
Who cannot join
- Has only facial AD.
- Has more than 20 Geographic Body Site Areas (GBSA) if to be enrolled into Cohort 2 or more than 10 GBSA if to be enrolled in Cohort 3 that are affected by AD. These GBSA restrictions exclude face, scalp, genitalia, and groin lesions. If the total number of allowable GBSAs is exceeded, the participant may be allowed to enroll after discussion with the Concerto Medical Monitor, but these additional sites must not have ENS-002 applied.
- Presence of non-AD dermatologic disorder(s) including, but not limited to, the following dermatitides: photodermatitis, allergic contact, infestations (including scabies), eczematous eruption (eg, secondary to calcium channel blockers), nummular, stasis, dermatitis herpetiformis, xerotic, widespread seborrheic, bullous pemphigoid (prodromal phase), eczematous psoriasis, or mycosis fungoides (Sezary syndrome).
- Presence of idiopathic chronic eczematous eruption of aging - defined as new-onset, atopic-like dermatitis presenting in people > 50 years old with no history of childhood AD.
- Presence of indwelling arterial or venous catheters.
- Cardiac valve disease history or artificial valve or pacemaker in place.
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- Implanted devices/prostheses including, but not limited to, eye lens, knee, hip, dental implants (but not caps or crowns), etc. replacements.
- History of Grade 2 or higher neutropenia or leukopenia (except for known benign neutropenia typical for Fy(a-b-) status [formerly known as benign ethnic neutropenia or BEN]).
- Unwilling to stop hair removal by any method (including shaving, waxing, or depilatory creams) in ENS-002 administration body sites for 7 days prior to the first ENS-002 administration and for at least 7 days after the last ENS-002 administration.
- Any significant breaks or cracks in the skin in the target areas of ENS-002 administration, including severe excoriations or open or weeping wounds suggestive of an active infection/increased susceptibility to infection.
- Clinically significant immunodeficiency (congenital or acquired [including a history of treated or untreated HIV, malnutrition, chronic viral infection]).
- Netherton syndrome or other genodermatoses resulting in a defective epidermal barrier.
- Active malignancy or history of malignancy in the past 3 years (Exceptions: superficial skin cancers - squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only and indolent prostate cancer).
- Clinically significant cardiovascular, liver, pulmonary, neurologic, metabolic, or kidney disease or any other comorbid medical, surgical, social, or psychiatric condition, that, in the opinion of the investigator, puts the participant at increased risk, might lead to study noncompliance, and/or confounds interpretation of safety and efficacy data.
- Required to take immunosuppressive drugs (eg, including but not limited to chemotherapy, systemic corticosteroids [≥ 10 mg prednisone equivalent/day; allowed corticosteroids: inhaled, intra-articular, topical low- to mid-potency creams (and lotions, gels, foams, etc.); use of allowed topical corticosteroids only after discussion and agreement with Medical Monitor, or if systemic, permitted at doses intended only for adrenal replacement, or if ≥ 5 days prior to first ENS-002 administration, on a one-time basis as a prophylaxis for imaging procedures], anti-tumor necrosis factor, colchicine, hydroxychloroquine, sulfasalazine, dapsone, methotrexate, mycophenylate mofetil, azathioprine, anti-interluekin-6 (anti-IL-6) antibody, anti-IL-1 antibody, or anti-CD20 antibody).
- Lives with or has frequent contact with individual(s) with implantable medical devices including, but not limited to, artificial eye lens, artificial joint, cardiac stents, indwelling venous or arterial catheters, cardiac valvular disease, or artificial valve in place; or who have severe skin barrier defects or known immunodeficiency (congenital or acquired [eg, treated or untreated HIV, malnutrition, chronic viral infections]). If there is any question on this exclusion criterion contact the Concerto medical monitor.
- Received oral or systemic antibiotics within 21 days prior to screening.
- Inability to tolerate > 7 days without topical AD treatments and topical antibiotics (prescription or over-the-counter [OTC]) or has had topical antibiotics ≤ 7 days prior to screening.
- Exceptions:
- allowed emollients and low- and mid-potency corticosteroid creams. Low- and mid-potency corticosteroid creams may be allowed without a washout, but only after discussion and agreement with Concerto Medical Monitor. Allowed emollients may be substituted for disallowed emollients during screening as long as this occurs at least 7 days before the planned first ENS-002 administration.
- Therapy prior to the first planned dose of ENS-002 with one or more of the following:
- Systemic corticosteroids within 28 days
- Topical high-potency corticosteroids within 28 days
- Low- and mid-potency corticosteroid creams within 14 days. These may be allowed if the participant is on a stable dose and after discussion and agreement with the Concerto Medical Monitor.
- Topical phosphodiesterase inhibitors within 7 days
- Emollients within 7 days, other than those emollients allowed in this study. If a participant has used a product with a 7-, 14-, or 28-day eligibility limit, a minimum of a 7-, 14-, or 28-day washout, respectively, is required before the first planned dose of ENS-002.
- Treatment with systemic therapies with anti-pruritic (eg, tricyclic antidepressants, sedatives, tranquilizers, marijuana or other cannabinoids, opioid receptor agonists/antagonists) or pruritus- inducing (eg, opioids, angiotensin-converting enzyme inhibitors, cocaine, antimalarials) potential within 28 days prior to the first planned dose of ENS-002.
- Therapy within 28 days prior to the first planned dose of ENS-002 with any immuno-modulating agents (eg, cyclosporine, azathioprine, methotrexate), phototherapy, or indoor tanning.
- Therapy within 56 days or 5 half-lives (whichever is longer) prior to the first planned dose of ENS-002 with investigational drugs or any Janus kinase inhibitors (JAKs).
- Concurrent therapy with dupilumab, tralokinumab, or lebrikizumab is allowed as long as participant has been on a stable dose for
- ≥ 16 weeks prior to the first planned dose of ENS-002. If a participant was taking any of these agents but has stopped, then a 56-day or five half-lives (whichever is longer) period is required before the first planned dose of ENS-002.
- Bleach baths within 30 days prior to the first planned dose of ENS-002.
- Use of any live topical bacterial product (OTC products within 4 weeks or investigational bacteria within 365 days) prior to the first planned dose of ENS-002.
- Allergic to any of the excipients in ENS-002 (pea hydrolysate, potassium phosphate dibasic, sodium chloride, yeast extract, water for injection, glycerol, and methylcellulose).
- Unable to use at least 2 of the 6 rescue antibiotics that cover all 3 bacteria in ENS-002.
- Pregnant or planning to attempt to become pregnant during this study, breast feeding, breast pumping, or planning to breast feed.
- Participant with a pregnant or breastfeeding partner or a partner planning to attempt to become pregnant during the study.
- Unable to demonstrate proper ENS-002 application technique despite proficiency training.
- Any prior exposure to ENS-002.
- Is biologically a WOCBP; eg, has not had a hysterectomy, has not been in menopause for at least one year, and cannot or is unable or unwilling to use highly effective birth control measures during this study and for 90 days after the last administration of ENS-002.
- If biologically male and fertile, cannot donate sperm and must adhere to highly effective birth control measures during this study and for 90 days after the last administration of ENS-002.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Derm Research
Austin, Texas, 78759
Northeast Dermatology Associates
Beverly, Massachusetts, 01915
Encore Medical Research
Hollywood, Florida, 33024
About this study
Official title: Phase 1 First in Human Dose Escalation and Safety Study of Topical ENS-002 for Atopic Dermatitis in Adults
The goal of this study is to determine the safety and effects of ENS-002, a live biotherapeutic product (LBP) consisting of commensal, clonal, non-pathogenic bacteria in participants with atopic dermatitis.
Read the detailed description
This is a Phase 1, open-label, non-randomized, study investigating ENS-002, a live biotherapeutic product (LBP) consisting of commensal, clonal non-pathogenic bacteria
The purpose of this dose escalation study is to determine the recommended Phase 2 dose (RP2D) of ENS-002 in participants with mild, moderate or severe atopic dermatitis.
Participation in this study will continue until dose limiting toxicity or therapy intolerance, or participant withdrawal.
- Conditions
- Atopic Dermatitis, Atopic Dermatitis Eczema
- Being tested
- ENS-002
- Keywords
- Dermatitis, Eczema
- Medical subject headings
- Dermatitis, Atopic, Dermatitis, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENS-002Biological
Live biotherapeutic product (LBP) consisting of commensal, clonal, non-pathogenic bacteria.
Low Dose ENS-002 High Dose ENS-002
| Study group | Role | What they receive |
|---|---|---|
| ENS-002 | Experimental | 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 target site once daily for 7 days.
Cohort 2 - QD dose of high dose ENS-002 in subjects with mild, moderate or severe Atopic Dermatitis. 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 in subjects with mild, moderate or severe Atopic Dermatitis applied topically to all affected skin (excluding scalp, face, groin, genitalia) twice daily for 14 days Receives: Biological: ENS-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of ENS-002 total doses
Incidence of adverse events after applying different total doses of ENS-002 as measured by clinical laboratory tests, vital signs and physical examination at end of treatment compared to baseline
Measured: Up to 43 days
Safety of ENS-002 dose frequency
Incidence of adverse events after applying different dose frequencies of ENS-002 as measured by clinical laboratory tests, vital signs and physical examination at end of treatment compared to baseline
Measured: Up to 43 days
Safety of ENS-002 different dose durations
Incidence of adverse events after applying different dose durations of ENS-002 as measured by clinical laboratory tests, vital signs and physical examination at end of treatment compared to baseline
Measured: Up to 43 days
Tolerability of ENS-002 total doses
Evaluate the tolerability of different total doses of ENS-002 administration as measured by clinical laboratory tests, vital signs and physical examination at end of treatment compared to baseline
Measured: Up to 43 days
Tolerability of ENS-002 different dose frequencies
Evaluate the tolerability of different dose frequencies of ENS-002 administration as measured by clinical laboratory tests, vital signs and physical examination at end of treatment compared to baseline
Measured: Up to 43 days
Tolerability of ENS-002 different dose durations
Evaluate the tolerability of different dose durations of ENS-002 administration as measured by clinical laboratory tests, vital signs and physical examination at end of treatment compared to baseline
Measured: Up to 43 days
Recommended Phase 2 Dose (RP2D)
Evaluate the safety of applying different total doses, dose frequencies, and durations of ENS-002 administration to determine a tentative recommended Phase 2 dose (RP2D).
Measured: Up to 43 days
Secondary outcomes (19)
Levels of specified bacterial colonization on affected skin
Measure levels of specified bacterial colonization on affected skin by quantitative polymerase chain reaction (qPCR).
Measured: Up to 43 days
Levels of specified bacterial colonization on non-affected skin
Measure levels of specified bacterial colonization on non-affected skin at end of treatment compared to baseline by quantitative polymerase chain reaction (qPCR).
Measured: Up to 43 days
ENS-002 skin colonization
Measure extent of ENS-002 skin colonization at end of treatment compared to baseline quantitative by polymerase chain reaction (qPCR).
Measured: Up to 43 days
Peak Pruritus Numerical Rating Scale (PPNRS) pruritus
Determine effects of ENS-002 on pruritus by absolute and mean changes in PPNRS at end of treatment compared to baseline
Measured: Up to 43 days
Peak Pruritus Numerical Rating Scale (PPNRS) affected skin
Determine effects of ENS-002 on affected skin area by absolute and mean changes in PPNRS at end of treatment compared to baseline
Measured: Up to 43 days
Peak Pruritus Numerical Rating Scale (PPNRS) severity
Determine effects of ENS-002 on severity by absolute and mean changes in PPNRS at end of treatment compared to baseline
Measured: Up to 43 days
Severity of Pruritus Scale (SPS) pruritus
Determine effects of ENS-002 on pruritus by absolute and mean changes in SPS at end of treatment compared to baseline
Measured: Up to 43 days
Severity of Pruritus Scale (SPS) affected skin
Determine effects of ENS-002 on affected skin area by absolute and mean changes in SPS at end of treatment compared to baseline
Measured: Up to 43 days
Severity of Pruritus Scale (SPS) severity
Determine effects of ENS-002 on severity by absolute and mean changes in SPS at end of treatment compared to baseline
Measured: Up to 43 days
Eczema Area and Severity Index (EASI) affected skin
Determine effects of ENS-002 on affected skin area by absolute change and percent of participants with a ≥ 50%, ≥ 75%, or ≥ 90% reduction in EASI at end of treatment compared to baseline
Measured: Up to 43 days
Eczema Area and Severity Index (EASI) severity
Determine effects of ENS-002 on severity by absolute change and percent of participants with a ≥ 50%, ≥ 75%, or ≥ 90% reduction in EASI at end of treatment compared to baseline
Measured: Up to 43 days
Investigator Global Assessment (IGA) 0 to 1
Determine percent of participants with an Investigator Global Assessment (IGA) of 0 or 1 at end of treatment compared to baseline
Measured: Up to 43 days
Investigator Global Assessment (IGA) absolute decrease of at least 2 points
Determine percent of participants with an absolute decrease of at least 2 points for moderate atopic dermatitis (AD) in Investigator Global Assessment (IGA) at end of treatment compared to baseline
Measured: Up to 43 days
Body Surface Area (BSA) absolute change
Absolute change from baseline in percent BSA affected
Measured: Up to 43 days
Body Surface Area (BSA) mean change
Mean change from baseline in percent BSA affected
Measured: Up to 43 days
Changes in corticosteroid use by participants
Determine type, potency and frequency of corticosteroid use
Measured: Up to 43 days
Changes in corticosteroid use for flares
Determine number of participants resorting to corticosteroids for flares.
Measured: Up to 43 days
ENS-002 Administration Compliance - percentage of planned administrations
Assess compliance of actual ENS-002 administrations as a percentage of planned administrations determined by counting used and unused vials and asking participants
Measured: Up to 14 days
ENS-002 Administration Compliance recorded in ePRO diary
Assess compliance of actual ENS-002 administrations by directed questions as recorded in an electronic participant reported outcome (ePRO) diary.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start18 Sep 2024
- Primary completion4 Aug 2025
- Study completion4 Aug 2025
Why it stopped: Planned safety, efficacy and proof of mechanism obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 3 participants will be included in each of three cohorts of ENS-002.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concerto Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernardo Cervantes, PhD, Study chair, Concerto Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469385
- Sponsor's protocol ID
- ENS-002-01
- Acronym
- EnSync
- Status last verified
- Aug 2025
- First submitted
- 17 Jun 2024
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 First in Human Dose Escalation and Safety Study of Topical ENS-002 for Atopic Dermatitis in Adults
- ClinicalTrials.gov ID
- NCT06469385
- Acronym / sponsor ID
- EnSync / ENS-002-01
- Conditions
- Atopic Dermatitis, Atopic Dermatitis Eczema
- Keywords
- Dermatitis, Eczema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Planned safety, efficacy and proof of mechanism obtained
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Concerto BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 21 Jun 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 study is to determine the safety and effects of ENS-002, a live biotherapeutic product (LBP) consisting of commensal, clonal, non-pathogenic bacteria in participants with atopic dermatitis.
Detailed description
This is a Phase 1, open-label, non-randomized, study investigating ENS-002, a live biotherapeutic product (LBP) consisting of commensal, clonal non-pathogenic bacteria
The purpose of this dose escalation study is to determine the recommended Phase 2 dose (RP2D) of ENS-002 in participants with mild, moderate or severe atopic dermatitis.
Participation in this study will continue until dose limiting toxicity or therapy intolerance, or participant withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3 participants will be included in each of three cohorts of ENS-002.
| Arm | Type | Receives |
|---|---|---|
| ENS-002 | Experimental | Biological: ENS-002ENS-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 target site once daily for 7 days. Cohort 2 - QD dose of high dose ENS-002 in subjects with mild, moderate or severe Atopic Dermatitis. 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 in subjects with mild, moderate or severe Atopic Dermatitis applied topically to all affected skin (excluding scalp, face, groin, genitalia) twice daily for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Able to understand and sign an informed consent form (ICF).
- Age 18 years or older on the day of signing the ICF.
- Diagnosis of AD according to Hanifin and Rajka
- Atopic dermatitis has been diagnosed and present for ≥ 6 months prior to the first planned ENS-002 administration.
- EASI (Eczema Area and Severity Index) score of 5 to 7 (mild) or 7.1 to 21 (moderate), or ≥ 21.1 or severe at screening.
Key exclusion criteria (41 listed)
- Has only facial AD.
- Has more than 20 Geographic Body Site Areas (GBSA) if to be enrolled into Cohort 2 or more than 10 GBSA if to be enrolled in Cohort 3 that are affected by AD. These GBSA restrictions exclude face, scalp, genitalia, and groin lesions. If the total number of allowable GBSAs is exceeded, the participant may be allowed to enroll after discussion with the Concerto Medical Monitor, but these additional sites must not have ENS-002 applied.
- Presence of non-AD dermatologic disorder(s) including, but not limited to, the following dermatitides: photodermatitis, allergic contact, infestations (including scabies), eczematous eruption (eg, secondary to calcium channel blockers), nummular, stasis, dermatitis herpetiformis, xerotic, widespread seborrheic, bullous pemphigoid (prodromal phase), eczematous psoriasis, or mycosis fungoides (Sezary syndrome).
- Presence of idiopathic chronic eczematous eruption of aging - defined as new-onset, atopic-like dermatitis presenting in people > 50 years old with no history of childhood AD.
- Presence of indwelling arterial or venous catheters.
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 |
|---|---|---|
| ENS-002Live biotherapeutic product (LBP) consisting of commensal, clonal, non-pathogenic bacteria. Low Dose ENS-002 High Dose ENS-002 | Biological | ENS-002 |
Primary outcome
Safety of ENS-002 total doses
Time frame: Up to 43 days
Incidence of adverse events after applying different total doses of ENS-002 as measured by clinical laboratory tests, vital signs and physical examination at end of treatment compared to baseline
Safety of ENS-002 dose frequency
Time frame: Up to 43 days
Incidence of adverse events after applying different dose frequencies of ENS-002 as measured by clinical laboratory tests, vital signs and physical examination at end of treatment compared to baseline
Safety of ENS-002 different dose durations
Time frame: Up to 43 days
Incidence of adverse events after applying different dose durations of ENS-002 as measured by clinical laboratory tests, vital signs and physical examination at end of treatment compared to baseline
Tolerability of ENS-002 total doses
Time frame: Up to 43 days
Evaluate the tolerability of different total doses of ENS-002 administration as measured by clinical laboratory tests, vital signs and physical examination at end of treatment compared to baseline
Tolerability of ENS-002 different dose frequencies
Time frame: Up to 43 days
Evaluate the tolerability of different dose frequencies of ENS-002 administration as measured by clinical laboratory tests, vital signs and physical examination at end of treatment compared to baseline
Tolerability of ENS-002 different dose durations
Time frame: Up to 43 days
Evaluate the tolerability of different dose durations of ENS-002 administration as measured by clinical laboratory tests, vital signs and physical examination at end of treatment compared to baseline
Recommended Phase 2 Dose (RP2D)
Time frame: Up to 43 days
Evaluate the safety of applying different total doses, dose frequencies, and durations of ENS-002 administration to determine a tentative recommended Phase 2 dose (RP2D).
19 secondary outcomes
Levels of specified bacterial colonization on affected skin
Time frame: Up to 43 days
Levels of specified bacterial colonization on non-affected skin
Time frame: Up to 43 days
ENS-002 skin colonization
Time frame: Up to 43 days
Peak Pruritus Numerical Rating Scale (PPNRS) pruritus
Time frame: Up to 43 days
Peak Pruritus Numerical Rating Scale (PPNRS) affected skin
Time frame: Up to 43 days
Peak Pruritus Numerical Rating Scale (PPNRS) severity
Time frame: Up to 43 days
Severity of Pruritus Scale (SPS) pruritus
Time frame: Up to 43 days
Severity of Pruritus Scale (SPS) affected skin
Time frame: Up to 43 days
Severity of Pruritus Scale (SPS) severity
Time frame: Up to 43 days
Eczema Area and Severity Index (EASI) affected skin
Time frame: Up to 43 days
Eczema Area and Severity Index (EASI) severity
Time frame: Up to 43 days
Investigator Global Assessment (IGA) 0 to 1
Time frame: Up to 43 days
Investigator Global Assessment (IGA) absolute decrease of at least 2 points
Time frame: Up to 43 days
Body Surface Area (BSA) absolute change
Time frame: Up to 43 days
Body Surface Area (BSA) mean change
Time frame: Up to 43 days
Changes in corticosteroid use by participants
Time frame: Up to 43 days
Changes in corticosteroid use for flares
Time frame: Up to 43 days
ENS-002 Administration Compliance - percentage of planned administrations
Time frame: Up to 14 days
ENS-002 Administration Compliance recorded in ePRO diary
Time frame: Up to 14 days
Results and safety
The study was stopped early (reason given: Planned safety, efficacy and proof of mechanism obtained). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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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. This study is not recruiting at the moment.
Bernardo Cervantes, PhD study chair
Concerto Biosciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ENS-002 in people with Atopic Dermatitis and Atopic Dermatitis Eczema, run by Concerto Biosciences at 3 sites 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 17 inclusion and 41 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: stopped early, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Planned safety, efficacy and proof of mechanism obtained). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of ENS-002 total doses (time frame: Up to 43 days). The study lists 7 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 14 Aug 2025.