RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2023-04-18

Study Completion:2025-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06055361

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Hugh Lee

CONTACT

1-301-540-2600

hughlee@kcrnresearch.com

Study Locations (Sites)

Arkansas Research Trials

North Little Rock, Arkansas, 72117

United States

DermDox Centers for Dermatology

Camp Hill, Pennsylvania, 17011

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Brexogen Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-18

Study Completion Date2025-12-30

Study Record Updates

Study Start Date2023-04-18

Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

Atopic dermatitis

Additional Relevant MeSH Terms

Atopic Dermatitis