Investigating a new injection for moderate to severe atopic dermatitis
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of BxC-I17e Administered Subcutaneously in Patients With Moderate to Severe Atopic Dermatitis
PHASE1 · Brexogen Inc. · NCT06055361
This study is testing a new injection for people with moderate to severe atopic dermatitis to see if it can help improve their symptoms when other treatments haven't worked well.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brexogen Inc. (industry) |
| Locations | 3 sites (North Little Rock, Arkansas and 2 other locations) |
| Trial ID | NCT06055361 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and preliminary efficacy of BxC-I17e, administered as a single and multiple subcutaneous injections, in patients suffering from moderate to severe atopic dermatitis. Participants will be monitored for their response to the treatment and any potential side effects. The study aims to provide insights into how well this new treatment can manage symptoms in individuals who have not responded adequately to existing therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a documented history of moderate to severe atopic dermatitis and inadequate response to previous treatments.
Not a fit: Patients with significant laboratory abnormalities or active dermatological conditions unrelated to atopic dermatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new effective option for patients with moderate to severe atopic dermatitis who have not found relief with current therapies.
How similar studies have performed: Other studies have shown promise with similar approaches in treating atopic dermatitis, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients (males or females) aged 18 years or older. 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: 1. 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 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
Where this trial is running
North Little Rock, Arkansas and 2 other locations
- Arkansas Research Trials — North Little Rock, Arkansas, United States (RECRUITING)
- DermDox Centers for Dermatology — Camp Hill, Pennsylvania, United States (RECRUITING)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Study coordinator: Hugh Lee
- Email: hughlee@kcrnresearch.com
- Phone: 1-301-540-2600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atopic Dermatitis, Atopic dermatitis, exosome, extracellular vesicles, EV