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Tests treatment safety and results for Atopic Dermatitis
Official title 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
ClinicalTrials.gov ID: NCT06055361
What this study is testing
What is BxC-I17e (primed iMSC derived Extracellular vesicles(EV))?
BxC-I17e (primed iMSC derived Extracellular vesicles(EV)) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for atopic dermatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients (males or females) aged 18 years or older.
- Patients have documented history of moderate to severe AD, that has been present for at least 1 year
- History of inadequate response to a stable regimen of TCSs or TCIs as treatment for AD
- 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.
- Willingness and ability to comply with clinic visits and study-related procedures.
You likely can't join if
- Presence of any of the following laboratory abnormalities
- Hemoglobin \< 11 g/dL
- WBC \< 3.5 × 103/μL
- Platelet count \< 125 × 103/μL
- Neutrophils \< 1.75 × 103/μL
- AST/ALT \> 1.5 × ULN
See the full eligibility criteria
- Patients (males or females) aged 18 years or older.
- Patients have documented history of moderate to severe AD, that has been present for at least 1 year
- History of inadequate response to a stable regimen of TCSs or TCIs as treatment for AD
- 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.
- Willingness and ability to comply with clinic visits and study-related procedures.
- Patients should be able to read, understand, and be willing to sign the ICF
- Presence of any of the following laboratory abnormalities
- 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
- Positive test for hepatitis B surface antigen, and/or hepatitis C antibody
- Active dermatologic conditions that may confound the diagnosis of AD
- Prior exposure to any investigational systemic treatment or is currently enrolled in another clinical study
- 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...
- Treatment with TCS, and/or TCI, within 1 week prior to the Baseline Visit.
- Known history of human immunodeficiency virus (HIV) infection
- Pregnant or breastfeeding women
The study team makes the final eligibility decision.
Where it's taking place
- North Little Rock, Arkansas, United States
- Camp Hill, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include North Little Rock, Arkansas, United States; Camp Hill, Pennsylvania, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.