A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Repeated-dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis
NCT ID: NCT06055374
Last Updated: 2024-08-09
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.
WITHDRAWN
PHASE1
INTERVENTIONAL
2024-05-01
2025-08-30
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 Single and Multiple Dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis
NCT06055361
A Study in Subjects With Moderate Atopic Dermatitis
NCT03175354
A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE SUBCUTANEOUS INJECTIONS OF SHR-1819 IN PATIENTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
NCT05197023
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
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
* Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e
* Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses
BxC-I17e
Pharmaceutical form : solution for injection
Placebo
* Subcutaneous (SC) injection of the matching placebo
* Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses
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
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BRE-AD01-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.