A Phase 1 interventional study of BxC-I17e (primed iMSC derived Extracellular vesicles(EV)) and Placebo in Atopic Dermatitis, sponsored by Brexogen Inc.. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Brexogen Inc. · Phase 1, Interventional, and Treatment
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)
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's planned enrollment of 45 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Brexogen Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Presence of any of the following laboratory abnormalities
* Subcutaneous (SC) injection of 25, 50, or 100 ug BxC-I17e * Single dose on Day 1
Drug: BxC-I17e (primed iMSC derived Extracellular vesicles(EV))
* Subcutaneous (SC) injection of the matching placebo * Single dose on Day 1
Drug: Placebo
* Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e * 4 doses on Day 1, 15, 29, and 43
Drug: BxC-I17e (primed iMSC derived Extracellular vesicles(EV))
* Subcutaneous (SC) injection of the matching placebo * 4 doses on Day 1, 15, 29, and 43
Drug: Placebo
Pharmaceutical form : solution for injection
Pharmaceutical form : solution for injection
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0
Time frame: Baseline to Week 26
Incidence, severity and relationship of adverse events(AEs)
Incidence, severity and relationship of adverse events as assessed by CTCAE v5.0
Time frame: Baseline to Week 26
Number of abnormalities and change from baseline in Vital signs
Supine blood pressure and pulse rate, tympanic temperature, and respiratory rate
Time frame: Baseline to Week 26
Number of abnormalities in 12-lead electrocardiogram (ECG)
PR interval, QRS interval, RR interval, QT interval and QT interval using Friderica's correction (QTcF)
Time frame: Baseline to Week 26
Number of abnormalities in clinical laboratory parameter
Hematology, clinical chemistry, and urinalysis parameters
Time frame: Baseline to Week 26
Frequency and proportion of clinically significant finding of physical examination
Assessments of the following body categories : skin, HEENT (head, eye, ears, nose, and throat), cardiovascular, respiratory, gastrointestinal, endocrine/metabolic, genitourinary, psychiatric, hematologic/lymphatics, musculoskeletal, neurologic, hepatic, and allergic/immunologic
Time frame: Baseline to Week 26
Proportion of patients who achieved the Investigator's Global Assessment (IGA) score of 0 or 1
The IGA is an assessment instrument used in clinical studies to rate the severity of Atopic dermatitis globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: Baseline to Week 8 (single dose) or Week 14 (multiple dose)
Change and percent change in Body Surface Area (BSA)
The BSA affected by atopic dermatitis will be assessed for each major section of the body (head, trunk, arms, and legs). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Time frame: Baseline to Week 8 (single dose) or Week 14 (multiple dose)
Change and percent change in Eczema Area and Severity Index (EASI)
The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.
Time frame: Baseline to Week 8 (single dose) or Week 14 (multiple dose)
Change and percent change in Scoring Atopic Dermatitis (SCORAD)
The SCORAD is a clinical tool for assessing the severity of Atopic Dermatitis. Total score ranged from 0 (absent disease) to 103 (severe disease).
Time frame: Baseline to Week 8 (single dose) or Week 14 (multiple dose)
Change and percent change in Pruritus Numerical Rating Scale (NRS)
The Pruritus NRS is a simple assessment tool used to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the' worst itch imaginable'
Time frame: Baseline to Week 8 (single dose) or Week 14 (multiple dose)
Change and percent change in Dermatology Life Quality Index (DLQI)
The DLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life. The higher the score, the greater the impact is on the quality of life
Time frame: Baseline to Week 8 (single dose) or Week 14 (multiple dose)
Change and percent change in Patient-Oriented Eczema Measure (POEM)
The POEM is a validated 7-item questionnaire used to assess disease symptoms with a scoring system of 1 to 28. The higher score, the higher morbidity
Time frame: Baseline to Week 8 (single dose) or Week 14 (multiple dose)
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.