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New skin disease drug enters first human trials

NCT ID NCT07412691

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 6 times

Summary

This study tests a new drug called BG-A3004 for the first time in humans. It aims to check the drug's safety and how the body processes it in healthy volunteers and people with immune-related skin diseases. The study is split into two parts: single dose in healthy people and multiple doses in patients. Results will help decide if further testing is warranted.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 98 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * 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. * 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. Exclusion Criteria: * 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 * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    11 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Beijing Tongren Hospital, Cmu

    RECRUITING

    Beijing, Beijing Municipality, 100010, China

  • Hangzhou First Peoples Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310006, China

  • Huashan Hospital Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200040, China

  • Peking University First Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • Suzhou Municipal Hospital

    RECRUITING

    Suzhou, Jiangsu, 215002, China

  • The First Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 630014, China

  • The First Affiliated Hospital of Fujian Medical University

    RECRUITING

    Fuzhou, Fujian, 350005, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110001, China

  • The Second Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050000, China

  • Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, 410008, China

More trials for these conditions

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