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Skin DiseasesPhase 1NCT07412691

A Study to Evaluate the Safety of BG-A3004 in Healthy Participants and Patients With Immune-Mediated Skin Diseases

A Phase 1 study testing BG-A3004 in people with Skin Diseases, run by BeOne Medicines at 11 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Skin Diseases
What is being tested?
BG-A3004
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
98 participants
Where
11 sitesChina
Study dates
19 Mar 2026to 8 Aug 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
  • Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 180 days after the last dose of study drug. They must also have a negative urine pregnancy test at baseline before first dose of study drug.
  • Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for 180 days after the last dose of study drug.
  • Part A (SAD) specific Inclusion criteria
  • Healthy participants as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
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  • Body mass index (BMI) of 19 to 28 kg/m^2
  • Part B (MAD) specific inclusion criteria:
  • Must be 18 to 60 years of age, inclusive, at the time of signing the informed consent.
  • Body mass index (BMI) of 18 to 32 kg/m^2
  • Patients with alopecia areata (AA), clinical diagnosis of AA with no other etiology of hair loss. Severity of Alopecia Tool (SALT) ≥ 25 and < 95 at screening and randomization.
  • Patients with cutaneous lichen planus (CLP), clinical and histological features of LP with predominant cutaneous involvement. Investigator's Global Assessment (IGA) score of 3 or 4 at screening and randomization.
  • Patients with nonsegmental vitiligo (NSV), documented clinical diagnosis of NSV for at least 3 months. Facial-Vitiligo Area Scoring Index (F-VASI) ≥ 0.5 and Total body-VASI ≥ 3 at screening and randomization.

Who cannot join

  • Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of the study drug or drugs of the same class.
  • Participants who are unable to comply with the requirements of the protocol, unless the written approval of the medical monitor has been obtained before informed consent.
  • Participants with any malignancy ≤ 5 years before randomization, except for any locally recurring cancer that has been treated curatively
  • Participants who were administered a live vaccine ≤ 28 days before randomization.
  • Female participants who are pregnant or are breastfeeding.
  • History of Tuberculosis or active, latent, or inadequately treated infection
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  • A known history of a primary immunodeficiency or an underlying condition such as HIV infection or splenectomy that predispose the participant to infections.
  • Known infection with hepatitis B virus [presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody( HBcAb)], or presence of hepatitis C virus antibody (HCV Ab)
  • Have a history of any lymphoproliferative disorder (such as Epstein Barr Virus-related lymphoproliferative disorder, as reported in some participants on other immunosuppressive drugs), history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current lymphatic disease.
  • Have an active infection or a history of infection within 6 months before the first dose of study drug that required hospitalization, or parenteral antimicrobial therapy, or have a history of opportunistic infection or a chronic or recurrent infectious disease that, in the opinion of the investigator, makes them unsuitable for this study.
  • Have or have had symptomatic herpes zoster or herpes simplex within 12 weeks, more than 1 episode of local herpes zoster, or a history (single episode) of disseminated zoster.
  • Acute disease state (e.g., asthma attack, nausea, vomiting, fever, or diarrhea) within 7 days prior to the first dose of study drug.
  • Part B(MAD) specific exclusion criteria:
  • Previous use of any Janus Kinase (JAK) inhibitor for any disease indication at any time.
  • Treatment with systemic immunomodulatory medications within 4 weeks or 5 half-lives (if known), whichever is longer prior to randomization, including immunosuppressants (e.g., methotrexate, cyclosporine, azathioprine); corticosteroids administered orally, intravenously, or intramuscularly; chloroquine derivatives; and oral phosphodiesterase-4 (PDE4) inhibitors (e.g., apremilast).
  • Phototherapy (UV or laser therapy) or cryotherapy within 4 weeks prior to randomization.
  • For AA patients, AA that affects more than scalp hair, e.g., eyebrow, eyelash, body hair.
  • For CLP patients, Patients whose LP is a predominantly bullous variant.
  • For NSV patients, Participants who have no pigmented hair within any of the vitiligo areas on the face.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Study Director contact

+1-877-828-5568

clinicaltrials@beonemed.com

11 sites in 1 country

China11 sites, 11 recruiting

  • Beijing Tongren Hospital, Cmu

    Beijing, Beijing Municipality, 100010

    Recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Recruiting

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 630014

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

    Recruiting

  • Hangzhou First Peoples Hospital

    Hangzhou, Zhejiang, 310006

    Recruiting

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Recruiting

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu, 215002

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Recruiting

Other trials in China

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of BG-A3004 in Healthy Participants and Patients With Immune-Mediated Skin Diseases

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
Skin Diseases
Being tested
BG-A3004, Placebo
Medical subject headings
Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BG-A3004Biological

    Administered subcutaneously

  • PlaceboBiological

    Administered subcutaneously

Study groups in NCT07412691
Study groupRoleWhat they receive
Part A: Single Ascending Doses (SAD) of BG-A3004ExperimentalSequential cohorts of increasing dose levels of BG-A3004 will be evaluated after a single dose in healthy participants.
Receives: Biological: BG-A3004
Part B: Multiple Ascending Doses (MAD) of BG-A3004ExperimentalSequential cohorts of increasing dose levels of BG-A3004 will be evaluated after multiple doses in participants with immune-mediated skin diseases.
Receives: Biological: BG-A3004
SAD PlaceboPlacebo comparatorSequential cohorts of healthy participants will receive a single dose of matching placebo.
Receives: Biological: Placebo
MAD PlaceboPlacebo comparatorSequential cohorts of participants with immune-mediated skin diseases will receive multiple doses of matching placebo.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A (SAD) and Part B (MAD): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically significant abnormalities from laboratory tests, vital signs and electrocardiogram results

    Measured: up to 24 weeks for Part A and 36 weeks for Part B

Secondary outcomes (5)

  1. Part A (SAD) and Part B (MAD): Maximum observed serum concentration of BG-3004 (Cmax)

    Measured: up to 24 weeks for Part A and 36 weeks for Part B

  2. Part A (SAD) and Part B (MAD): Area under the curve (AUC) of BG-3004

    Measured: up to 24 weeks for Part A and 36 weeks for Part B

  3. Part A (SAD) and Part B (MAD): Half-life of BG-3004 (t1/2)

    Measured: up to 24 weeks for Part A and 36 weeks for Part B

  4. Part A (SAD) and Part B (MAD): Number of Participants with Antidrug Antibodies (ADAs) against BG-A3004

    Measured: up to 24 weeks for Part A and 36 weeks for Part B

  5. Part B (MAD): Trough concentration (Ctrough) of BG-3004

    Measured: up to 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start19 Mar 2026
  3. Primary completion8 Aug 2028 (estimated)
  4. Study completion8 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
98 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07412691
Sponsor's protocol ID
BG-A3004-101
Status last verified
Mar 2026
First submitted
9 Feb 2026
Last updated
10 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BG-A3004 in people with Skin Diseases, run by BeOne Medicines at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director (+1-877-828-5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A (SAD) and Part B (MAD): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: up to 24 weeks for Part A and 36 weeks for Part B). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07412691.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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