Topical ENS-002 for Atopic Dermatitis in Adults
NCT Number: NCT06469385
Acronym: EnSync
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Atopic Dermatitis|Atopic Dermatitis Eczema
Interventions: BIOLOGICAL: ENS-002
Sponsor: Concerto Biosciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-25
Completion Date: 2024-12-20
Locations: Derm Research, Austin, Texas, 78759, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Levels of specified bacterial colonization on affected skin, Measure levels of specified bacterial colonization on affected skin by quantitative polymerase chain reaction (qPCR)., 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)., 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)., 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, Up to 43 days|Body Surface Area (BSA) absolute change, Absolute change from baseline in percent BSA affected, Up to 43 days|Body Surface Area (BSA) mean change, Mean change from baseline in percent BSA affected, Up to 43 days|Changes in corticosteroid use by participants, Determine type, potency and frequency of corticosteroid use, Up to 43 days|Changes in corticosteroid use for flares, Determine number of participants resorting to corticosteroids for flares., 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, 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., Up to 14 days
Other Outcome Measures: Changes in White Blood Count (WBC) in peripheral blood, Assess blood samples for changes in white blood cell (WBC) count after ENS-002 administration, Up to 43 days|Changes in WBC subsets in peripheral blood, Assess blood samples for changes in WBC subsets (eg, neutrophils, lymphocytes) after ENS-002 administration, Up to 43 days|Changes in C-Reactive Protein (CRP) in peripheral blood, Assess blood samples for changes in CRP after ENS-002 administration, Up to 43 days|Changes in immune cells in peripheral blood, Assess blood samples for changes in immune cells after ENS-002 administration, Up to 43 days|Changes in cytokines in peripheral blood, Assess blood samples for changes in cytokines after ENS-002 administration, Up to 43 days|Changes in immunoglobulin E (IgE) in peripheral blood, Assess blood samples for changes in immunoglobulin E (IgE) after ENS-002 administration, Up to 43 days|Changes in chemokines in peripheral blood, Assess blood samples for changes in chemokines after ENS-002 administration, Up to 43 days|Changes in skin inflammatory markers, Skin tape strips will be taken to assess changes in immune markers including cytokines and chemokines after ENS-002 administration, Up to 43 days|Microbiome changes on affected skin not administered ENS-002. Microbiome changes on affected and non-affected skin., Skin swabs to evaluate microbiome changes on affected skin that was not administered ENS-002, Up to 43 days|Microbiome changes on affected skin administered ENS-002. Microbiome changes on affected and non-affected skin., Skin swabs to evaluate microbiome changes on affected skin that was administered ENS-002, Up to 43 days|Microbiome changes on non-affected skin Microbiome changes on affected and non-affected skin., Skin swabs to evaluate microbiome changes on non-affected skin, Up to 43 days|Participant preferences and feedback on feasibility and tolerability of ENS-002 administration., Collect Electronic participant reported outcomes (ePRO). The ePRO diary will include specific questions on skin color change, pruritus, rash, pain, tenderness, fever, chills, night sweats, and other side effects, along with ease of application, skin feel, interference with use of emollients or other topically applied agents, effect on usual hygiene practices, residual feel after dosing has stopped, and effect on activities of daily living (eg, sleep, exercise, wearing clothing)., Up to 43 days