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New lupus drug candidate enters human trials

NCT ID NCT07185269

Disease control Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an experimental drug called SSGJ-626, an antibody that targets a protein on certain immune cells, in people with systemic lupus erythematosus (SLE). The trial will enroll 198 adults aged 18-70 with SLE. Participants will receive either the drug or a placebo as a shot under the skin. The main goal is to check safety and see if the drug can reduce lupus symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SSGJ-626 (an anti-BDCA2 antibody)
What this could lead to
If successful, this could lead to a new treatment option that helps control lupus symptoms and reduce disease activity.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not prove effective or safe. Side effects are possible, and results may not apply to all lupus patients.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 198 people

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

Started

Sep 2025

Expected to finish

Nov 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 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Able to understand protocol requirements and sign a written ICF. * Male or female subjects aged 18-70 years when signing the ICF. * Body weight between 40 and 90 kg. * Diagnosed with SLE at least 6 months before the Screening Visit by a qualified physician，confirmed according to the 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE. * At screening, meet at least one of the following criteria: 1. Anti-nuclear antibody (ANA) titer ≥ 1:80; 2. Positive anti-dsDNA antibody.. * Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 with clinical SLEDAI score ≥4 points at Screening and Baseline Visit . * Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent. Exclusion Criteria: * Study participant has a mixed connective tissue disease, and/or overlap syndrome of systemic lupus erythematosus (SLE) with systemic sclerosis. * Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition * Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening. * History of cancer. * Active severe lupus nephritis present within 2 months prior to baseline. Or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2, or protein:creatinine ratio \>2.0 g/g.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

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

Systemic lupus erythematosus (SLE)

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.