NCT06055361RecruitingPhase 1
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
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
Source: ClinicalTrials.gov · Last updated 19 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 12 Sept 2023
- Start date
- 18 Apr 2023
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Brexogen Inc.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06055361
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 45
- From 18 Apr 2023 to the primary completion date, 31 Mar 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 patient's participation in this study
- Treatment with TCS, and/or TCI, within 1 week prior to the Baseline Visit.
Other illness
- Positive test for hepatitis B surface antigen, and/or hepatitis C antibody
- Active dermatologic conditions that may confound the diagnosis of AD
- Known history of human immunodeficiency virus (HIV) infection
Lab values
- 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
Other
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| DermDox Centers for Dermatology Coordinator of this site? Confirm its status | Camp Hill | United States | Recruiting |
| Arkansas Research Trials Coordinator of this site? Confirm its status | North Little Rock | United States | Recruiting |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.