POC Study to Evaluate BSI-045B in Moderate-to-severe Atopic Dermatitis

NCT05932654 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: BSI-045B-002
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 17

Brief Summary

The study is a multicenter clinical trial and is designed as a proof-of-concept study to evaluate the efficacy, safety, tolerability, PK, immunogenicity, and PD of BSI-045B following SC injections. The study will enroll patients with moderate to severe AD to receive the 300 mg treatment. BSI-045B wil be firstly given weekly during Week 1 to Week 4, and then every 2 weeks (Q2W) to Week 24.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Proportion of Patients Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 26

  The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.

  Week 26

• Safety Profile of Study Treatment

  Number of Participants With Treatment-emergent Adverse Events

  Day 1 to Week 36

Secondary Outcomes (2)

• Pharmacokinetic Parameters

  Weeks 4, 24, and 26

• Immunogenicity Following BSI-045B Treatment

  Day 1 to Week 36

Other Outcomes (6)

• Exploratory Endpoint, Proportions of Patients Achieving at Least 50%, 90% Reductions in EASI

  Week 26

• Percent Change From Baseline in EASI at Each Visit

  Day 1 to Week 36

• Exploratory Endpoint, Proportion of Patients Achieving Investigator's Global Assessment (IGA) 0 or 1 at Week 26

  Day 1 to Week 36

Study Arms (1)

300 mg

EXPERIMENTAL

BSI-045B 300 mg SC QW × 4 weeks, then BSI-045B 300 mg SC Q2W through Week 24

Drug: BSI-045B

Interventions

BSI-045B DRUG

Patients will be treated with BSI-045B.

300 mg

Eligibility Criteria

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

You may qualify if:

• In the opinion of the Investigator, the patient is capable of understanding and complying with protocol requirements.
• The patient signs and dates a written ICF prior to the initiation of any study procedures.
• The patient has a diagnosis of AD (according to the criteria established by Hanifin and Rajka, 1980). The diagnosis of AD must have been present for at least 1 year, and the patient's AD must have been active for at least 3 months.
• The patient is aged 18 to 65 years, inclusive at the time of consent. Patients of any gender are eligible.
• The EASI is ≥12 at Screening and on Day 1.
• The score on the IGA is ≥3 (scale of 0 to 4) at Screening and on Day 1.
• The total body surface area (BSA) affected by AD is ≥10% as assessed by the physical examination at Screening and on Day -1.
• The patient has not received prior treatment with topical or systemic medications OR the patient has active disease despite topical or systemic treatment as per the Investigator at the time of screening.
• A male patient who is non-sterilized and sexually active with a female partner of childbearing potential, and female patient of childbearing potential who is sexually active with a non-sterilized male partner agrees to use highly effective contraception from the time of signing the ICF throughout the duration of the study and for 90 days (\~5 half lives) after the last dose of study drug.

You may not qualify if:

• The patient has another dermatologic condition that might confound a diagnosis of AD or a treatment assessment.
• The patient has any clinically significant illness that may affect the safety, increase the risk for seizure or lower the seizure threshold, or potentially confound the study results.
• The patient has abnormal laboratory values during the Screening Period: ALT and/or AST \> 1.5 ULN, total bilirubin ≥ 1.5 mg/dL, estimated glomerular filtration rate (GFR) \< 60 mL/min (based on Cockcroft-Gault calculation), hemoglobin≤ 10 g/dL, platelet count ≤ 150 ×103/µL, creatine kinase \> 2.5×ULN.
• The patient has a history of anaphylaxis following biologic therapy.
• The patient has a history of allergy to corticosteroids, diphenhydramine, hydroxyzine, cetirizine, or fexofenadine.
• The patient has a history of a clinically significant infection within 4 weeks prior to Screening.
• The patient has been diagnosed with a helminthic parasitic infection within 6 months prior to Screening.
• The patient has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to Screening or is unwilling to agree to abstain from alcohol and drugs (including cannabinoids) throughout the study.
• The patient had a major surgical or major dental procedure within 8 weeks prior to Screening.
• The patient is pregnant or lactating or intends to become pregnant or donate ova before, during, or within 90 days (\~ 5 half-lives) since the last dose of study drug.
• If male, the patient intends to donate sperm during this study or within 90 days (\~ 5 half-lives) since the last dose of study drug.
• The patient has a history of neurologic abnormalities including abnormal electroencephalography, brain injury including traumatic injury, perinatal cerebropathy, postnatal brain damage, blood-brain barrier abnormality, and cavernous angioma.
• The patient has a history of cerebral arteriosclerosis.
• The patient has a history of cancer. Patients with localized basal cell carcinoma, localized squamous cell carcinoma of the skin, or carcinoma in situ of the cervix may be included in the study if they have completed curative treatment at least 12 months prior to Screening. Patients with other malignant tumors may be included if they have completed curative treatment at least 5 years prior to the first dose of study drug.
• The patient has a positive test result for hepatitis B surface antigen (HbsAg), antihepatitis C virus (HCV), a history of active tuberculosis, a positive test result for human immunodeficiency virus (HIV), or a known history of HIV infection at Screening.

Sponsors & Collaborators

• Biosion, Inc.: lead

Study Sites (17)

First OC Dermatology - Fountain Valley

Fountain Valley, California, 92708, United States

Location

Center for Dermatology Clinical Research

Fremont, California, 94538, United States

Location

Profound Research LLC - Nashville - Corporate

Oceanside, California, 92056, United States

Location

The George Washington University School of Medicine and Health Science

Washington D.C., District of Columbia, 20037, United States

Location

Advanced Medical Research - Medical Dermatology Specialists

Sandy Springs, Georgia, 30328, United States

Location

Dawes Fretzin Clinical Research

Indianapolis, Indiana, 46250, United States

Location

Skin Sciences/Derm Research Pllc.

Louisville, Kentucky, 40217, United States

Location

Allcutis Research - Beverly, MA

Beverly, Massachusetts, 01915, United States

Location

Beacon Clinical Research

Quincy, Massachusetts, 02169, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Accellacare - Cary

Cary, North Carolina, 27518, United States

Location

Accellacare - Raleigh

Raleigh, North Carolina, 27609, United States

Location

Accellacare-Wilmington

Wilmington, North Carolina, 28411, United States

Location

Wright State Physicians Health Center

Fairborn, Ohio, 45324, United States

Location

Paddington Testing Company

Philadelphia, Pennsylvania, 19103, United States

Location

Center for Clinical Studies - Webster

Webster, Texas, 77598, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

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

Results Point of Contact

• Title: Kathy Zhang
• Organization: Biosion, Inc.

kathy.zhang@biosion.com

+86 18801904945

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: July 6, 2023
• Study Start: July 31, 2023
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2024
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)