A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Single and Multiple Dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis

Part of paid clinical trials in North Little Rock, Arkansas.

Sponsor
Brexogen Inc.
Study ID
NCT06055361
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BxC-I17e (primed iMSC derived Extracellular vesicles(EV)) — DRUG
    Pharmaceutical form : solution for injection
  • Placebo — DRUG
    Pharmaceutical form : solution for injection

Study Details

The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of a single and multiple SC dose of BxC-I17e in patients with moderate to severe atopic dermatitis (AD)

Key Dates

Start date
Apr 18, 2023
Status verified
Sep 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BxC-I17e (Single Dose)
    * Subcutaneous (SC) injection of 25, 50, or 100 ug BxC-I17e * Single dose on Day 1
  • Placebo Comparator: Placebo (Single Dose)
    * Subcutaneous (SC) injection of the matching placebo * Single dose on Day 1
  • Experimental: BxC-I17e (Multiple Dose)
    * Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e * 4 doses on Day 1, 15, 29, and 43
  • Placebo Comparator: Placebo (Multiple Dose)
    * Subcutaneous (SC) injection of the matching placebo * 4 doses on Day 1, 15, 29, and 43

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline to Week 26 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Arkansas Research TrialsNorth Little RockArkansas72117
Shawna S Owens
DermDox Centers for DermatologyCamp HillPennsylvania17011
Elise Magnine
University of PennsylvaniaPhiladelphiaPennsylvania19104
Paola Santos

Find similar trials in North Little Rock, AR

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Arkansas Research Trials· North Little Rock, ARDermDox Centers for Dermatology· Camp Hill, PAUniversity of Pennsylvania· Philadelphia, PA

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