Topical ENS-002 for Atopic Dermatitis in Adults

NCT06469385 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: ENS-002-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Atopic Dermatitis; Atopic Dermatitis Eczema

Keywords

Dermatitis; Eczema

Outcome Measures

Primary Outcomes (7)

• 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

  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

  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

  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

  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

  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

  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).

  Up to 43 days

Secondary Outcomes (19)

• Levels of specified bacterial colonization on affected skin

  Up to 43 days

• Levels of specified bacterial colonization on non-affected skin

  Up to 43 days

• ENS-002 skin colonization

  Up to 43 days

• Peak Pruritus Numerical Rating Scale (PPNRS) pruritus

  Up to 43 days

• Peak Pruritus Numerical Rating Scale (PPNRS) affected skin

  Up to 43 days

Other Outcomes (12)

• Changes in White Blood Count (WBC) in peripheral blood

  Up to 43 days

• Changes in WBC subsets in peripheral blood

  Up to 43 days

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

  Up to 43 days

Study Arms (1)

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

Biological: ENS-002

Interventions

ENS-002 BIOLOGICAL

Live biotherapeutic product (LBP) consisting of commensal, clonal, non-pathogenic bacteria. Low Dose ENS-002 High Dose ENS-002

ENS-002

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Concerto Biosciences: lead

Study Sites (3)

Encore Medical Research

Hollywood, Florida, 33024, United States

Location

Northeast Dermatology Associates

Beverly, Massachusetts, 01915, United States

Location

Derm Research

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Bernardo Cervantes, PhD

  Concerto Biosciences

  STUDY CHAIR

Study Design

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

Model Details: 3 participants will be included in each of three cohorts of ENS-002.

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 21, 2024
• Study Start: September 18, 2024
• Primary Completion: August 4, 2025
• Study Completion: August 4, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

US (3)