Actively Recruiting
A Study to Evaluate the Safety of BG-A3004 in Healthy Participants and Patients With Immune-Mediated Skin Diseases
Led by BeOne Medicines · Updated on 2026-03-23
98
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is the first-in-human study of BG-A3004. The study will evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of BG-A3004 after single and multiple doses administered in different dose levels in healthy participants (Part A) and patients with immune-mediated skin diseases (Part B), respectively. Study details include: * The study duration will be approximately 3 years. * The treatment duration will be 1 dose for Part A and 4 doses for Part B. * Safety follow-up period is 168 days after the last dose
CONDITIONS
Official Title
A Study to Evaluate the Safety of BG-A3004 in Healthy Participants and Patients With Immune-Mediated Skin Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent indicating understanding of the study
- Female participants of childbearing potential must use effective birth control and have a negative pregnancy test before dosing
- Nonsterile male participants must use effective birth control
- Part A: Healthy adults aged 18 to 55 years with BMI 19 to 28 kg/m²
- Part B: Adults aged 18 to 60 years with BMI 18 to 32 kg/m²
- Part B: Patients with alopecia areata diagnosed clinically, with SALT score ≥ 25 and < 95
- Part B: Patients with cutaneous lichen planus with IGA score of 3 or 4
- Part B: Patients with nonsegmental vitiligo diagnosed for at least 3 months, with F-VASI ≥ 0.5 and total body VASI ≥ 3
You will not qualify if you...
- History of severe allergic reactions or hypersensitivity to BG-A3004 or similar drugs
- Inability to comply with study protocol without medical monitor approval
- History of malignancy within 5 years except curatively treated local cancer
- Live vaccine administered within 28 days before randomization
- Pregnant or breastfeeding women
- History of tuberculosis, or active, latent, or inadequately treated infection
- Known primary immunodeficiency or conditions like HIV or splenectomy
- Known infection with hepatitis B or C viruses
- History of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma
- Active infection or infection requiring hospitalization or parenteral therapy within 6 months
- Symptomatic herpes zoster or simplex within 12 weeks, multiple episodes of local herpes zoster, or disseminated zoster
- Acute illness such as asthma attack, nausea, vomiting, fever, or diarrhea within 7 days before dosing
- Part B: Prior use of any Janus Kinase (JAK) inhibitor
- Part B: Systemic immunomodulatory treatment within 4 weeks or 5 half-lives before randomization
- Part B: Phototherapy or cryotherapy within 4 weeks before randomization
- Part B: Alopecia areata affecting areas beyond scalp hair
- Part B: Bullous variant of lichen planus
- Part B: No pigmented hair in vitiligo areas on face
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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