Investigating a new injection for moderate to severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Roflumilast Cream 0.3% for moderate to severe atopic dermatitis in children, adolescents, and adults

  A cream called roflumilast 0.3% is tested once daily to see if it helps people with moderate to severe atopic dermatitis, compared to a non-medicated cream, across ages 6 and up.

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• Nocturnal ScratchSense ring: test of automatic scratch detection in adults with itchy skin

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  Recruiting Replior AB · Grenoble · NCT07909967

• ADBest TREAT Registry for adults with atopic dermatitis

  A registry in Germany is collecting real-world data from adults with atopic dermatitis to see how treatments are used and how the disease affects quality of life.

  Recruiting Universitätsklinikum Hamburg-Eppendorf · Hamburg · NCT07904546

• How lebrikizumab affects the skin microbiome and mycobiome in adults with atopic dermatitis

  This study looks at whether lebrikizumab changes the skin bacteria, fungi, and specifically Staphylococcus species, in adults with moderate-to-severe atopic dermatitis.

  Recruiting University Hospital Bispebjerg and Frederiksberg · Copenhagen · NCT07807228

• QX-4533 safety study in healthy volunteers and people with moderate-to-severe atopic dermatitis

  This study tests the safety and tolerability of QX-4533, given as a pill, in healthy adults and in patients with moderate-to-severe atopic dermatitis to see how the drug behaves in the body and what side effects may occur.

  Recruiting Phase 1 QuantX Biosciences US Inc. · Shanghai, Shanghai Municipality · NCT07800104

• Tilrekimig for moderate-to-severe eczema in teens and adults

  A 52-week study will test tilrekimig against dupilumab and a placebo to see if it helps people 12 and older with moderate-to-severe atopic dermatitis.

  Recruiting at 31 sites Phase 3 Pfizer · Birmingham, Alabama and 49 other locations · NCT07783425

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.