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
NCT ID: NCT06055361
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
45 participants
INTERVENTIONAL
2023-04-18
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Repeated-dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis
NCT06055374
A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis That Are Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Advisable
NCT03428100
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
NCT06130566
A Study of Baricitinib (LY3009104) in Combination With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis
NCT03733301
Topically Applied AMTX-100 CF for Adult Patients With Mild to Moderate Atopic Dermatitis
NCT04313400
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BxC-I17e (Single Dose)
* Subcutaneous (SC) injection of 25, 50, or 100 ug BxC-I17e
* Single dose on Day 1
BxC-I17e (primed iMSC derived Extracellular vesicles(EV))
Pharmaceutical form : solution for injection
Placebo (Single Dose)
* Subcutaneous (SC) injection of the matching placebo
* Single dose on Day 1
Placebo
Pharmaceutical form : solution for injection
BxC-I17e (Multiple Dose)
* Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e
* 4 doses on Day 1, 15, 29, and 43
BxC-I17e (primed iMSC derived Extracellular vesicles(EV))
Pharmaceutical form : solution for injection
Placebo (Multiple Dose)
* Subcutaneous (SC) injection of the matching placebo
* 4 doses on Day 1, 15, 29, and 43
Placebo
Pharmaceutical form : solution for injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BxC-I17e (primed iMSC derived Extracellular vesicles(EV))
Pharmaceutical form : solution for injection
Placebo
Pharmaceutical form : solution for injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients have documented history of moderate to severe AD, that has been present for at least 1 year
3. History of inadequate response to a stable regimen of TCSs or TCIs as treatment for AD
4. Patients must agree to apply stable doses of additive-free, basic bland emollient lotions twice daily for at least 7 days before the Baseline Visit.
5. Willingness and ability to comply with clinic visits and study-related procedures.
6. Patients should be able to read, understand, and be willing to sign the ICF
Exclusion Criteria
* Hemoglobin \< 11 g/dL
* WBC \< 3.5 × 103/μL
* Platelet count \< 125 × 103/μL
* Neutrophils \< 1.75 × 103/μL
* AST/ALT \> 1.5 × ULN
* Total bilirubin \> ULN
* Creatinine \> ULN
* Creatine phosphokinase \> ULN
2. Positive test for hepatitis B surface antigen, and/or hepatitis C antibody
3. Active dermatologic conditions that may confound the diagnosis of AD
4. Prior exposure to any investigational systemic treatment or is currently enrolled in another clinical study
5. Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the patient's participation in this study
6. Treatment with TCS, and/or TCI, within 1 week prior to the Baseline Visit.
7. Known history of human immunodeficiency virus (HIV) infection
8. Pregnant or breastfeeding women
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Brexogen Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arkansas Research Trials
North Little Rock, Arkansas, United States
DermDox Centers for Dermatology
Camp Hill, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Shawna S Owens
Role: primary
Elise Magnine
Role: primary
Paola Santos
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BRE-AD01-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.