A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Repeated-dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis

NCT06055374 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: BRE-AD01-002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the safety, tolerability, and efficacy of a multiple SC dose of BxC-I17e in patients with moderate to severe atopic dermatitis (AD)

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs)

  Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0

  Baseline to Week 26

Secondary Outcomes (22)

• Incidence, severity and relationship of adverse events(AEs)

  Baseline to Week 26

• Number of abnormalities and change from baseline in Vital signs

  Baseline to Week 26

• Number of abnormalities in 12-lead electrocardiogram (ECG)

  Baseline to Week 26

• Number of abnormalities in clinical laboratory parameter

  Baseline to Week 26

• Frequency and proportion of clinically significant finding of physical examination

  Baseline to Week 26

Study Arms (2)

BxC-I17e

EXPERIMENTAL

* Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e * Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses

Drug: BxC-I17e

Placebo

PLACEBO COMPARATOR

* Subcutaneous (SC) injection of the matching placebo * Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses

Drug: Placebo

Interventions

BxC-I17e DRUG

Pharmaceutical form : solution for injection

BxC-I17e

Placebo DRUG

Pharmaceutical form : solution for injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Positive test for hepatitis B surface antigen, and/or hepatitis C antibody
• Active dermatologic conditions that may confound the diagnosis of AD
• 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
• Known history of human immunodeficiency virus (HIV) infection

Sponsors & Collaborators

• Brexogen Inc.: lead

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 26, 2023
• Study Start: May 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: August 30, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share