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New lupus shot aims to tame flares in phase 2 trial

NCT ID NCT07447986

Disease control Sponsor: Hangzhou Sumgen Biotech 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 18, 2026 · Updated 5 times

Summary

This phase 2 trial tests a new drug called SG301, given as a shot under the skin, for people with systemic lupus erythematosus (SLE). About 120 participants whose lupus is not well controlled by standard treatments will receive either SG301 or a placebo over several months. The goal is to see if SG301 can reduce disease activity and improve symptoms without causing serious side effects.

What this could mean

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

Active substance
SG301 (a biologic drug given as a shot under the skin)
What this could lead to
If it works, this could offer a new treatment option to help control lupus disease activity and reduce flares.
What could go wrong
This is an early phase 2 trial with only 120 people, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

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

Started

Mar 2026

Expected to finish

Dec 2027

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: 1. Voluntarily participate in the clinical study and sign a written informed consent form. 2. Participants must be diagnosed with SLE in accordance with the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatism (ACR) SLE classification criteria and have inadequate response to standard treatment, intolerance to standard treatment, or recurrent disease. 3. SLEDAI-2K score ≥ 8 points, with clinical features corresponding to a SLEDAI-2K score ≥ 4 points. 4. Positive serological test results for autoantibodies, defined as antinuclear antibody (ANA) positivity and/or anti-double-stranded DNA (anti-dsDNA) antibody positivity. 5. Body weight ≥ 35 kg. 6. Must have received standard treatment for at least 8 weeks before the first dose and maintained a stable dose of the treatment unchanged for at least 4 weeks before the first dose. 7. Participants of childbearing potential or whose partners are of childbearing potential must agree to use effective contraceptive measures throughout the entire study period and within 6 months after the last dose. Exclusion Criteria: 1. Previous use of CD38 or monoclonal antibodies targeting CD38. 2. Active central nervous system (CNS) disease within 2 months before the first dose, or CNS disease that the investigator believes may require treatment with prohibited therapies specified in the protocol. 3. Diagnosis of mixed connective tissue disease or a history of any overlap syndrome between SLE and systemic sclerosis. 4. Laboratory abnormalities. 5. Current acute or chronic infection meeting any of the following criteria. 6. Participation in any other clinical trial within 4 weeks before the first dose (excluding participants who provided informed consent but did not receive trial treatment, or only received placebo). 7. Use of any targeted T or B lymphocyte drugs (e.g., rituximab) within 3 months before the first dose. 8. Receipt of any B cell-depleting drugs (such as belimumab, telitacicept) within 4 weeks or 5 half-lives (whichever is shorter) before the first dose. 9. Receipt of JAK inhibitor treatment within 2 weeks before the first dose. 10. Presence of severe cardiovascular and cerebrovascular diseases. 11. Mycobacterium tuberculosis infection. 12. Presence of HIV infection, active hepatitis B, or hepatitis C. 13. Known history of active syphilis. 14. History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/or bone marrow transplantation. 15. Other conditions that the investigator believes would prevent the participant from participating in the study.

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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

    40 sites. 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

  • Changzhou Second People's Hospital

    RECRUITING

    Changzhou, Jiangsu, China

  • Dalian Municipal Central Hospital

    RECRUITING

    Dalian, Liaoning, China

  • GanSu Provincial Hospital

    RECRUITING

    Lanzhou, Gansu, China

  • Hebei General Hospital

    RECRUITING

    Shijiazhuang, Hebei, China

  • Hebei Zhongyuan Petrolium Central Hospital

    RECRUITING

    Langfang, Hebei, China

  • Heping Hospital Affiliated to Changzhi Medical College

    RECRUITING

    Changzhi, Shanxi, China

  • Huzhou Third People's Hospital

    RECRUITING

    Huzhou, Zhejiang, China

  • Jilin Provincial People's Hospital

    RECRUITING

    Changchun, Jilin, China

  • Jilin University First Hospital

    RECRUITING

    Changchun, Jilin, China

  • JingZhou Central Hospital

    RECRUITING

    Jingzhou, Hubei, China

  • Jining First People's Hospital

    RECRUITING

    Jining, Shandong, China

  • Linfen Central Hospital

    RECRUITING

    Linfen, Shanxi, China

  • Luoyang Central Hospital

    RECRUITING

    Luoyang, Henan, China

  • Northern Jiangsu People's Hospital

    RECRUITING

    Yangzhou, Jiangsu, China

  • Peking University People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • People's Hospital of Zhengzhou

    RECRUITING

    Zhengzhou, Henan, China

  • Pingxiang People's Hospital

    RECRUITING

    Pingxiang, Henan, China

  • Second Hospital of Shanxi Medical University

    RECRUITING

    Taiyuan, Shanxi, China

  • Shanxi Bethune Hospital

    RECRUITING

    Taiyuan, Shanxi, China

  • Shenzhen People's Hospital

    RECRUITING

    Shenzhen, Guangdong, China

  • Shiyan People's Hospital

    RECRUITING

    Shiyan, Hubei, China

  • The 2nd Affiliated Hospital of Harbin Medical University

    NOT_YET_RECRUITING

    Harbin, Heilongjiang, China

  • The Central Hospital of Wuhan

    RECRUITING

    Wuhan, Hubei, China

  • The First Affiliated Hospital of Gannan Medical University

    RECRUITING

    Ganzhou, Shanxi, China

  • The First Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, Guangxi, China

  • The First Affiliated Hospital of Guilin Medical University

    RECRUITING

    Guilin, Guangxi, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    RECRUITING

    Luoyang, Henan, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, China

  • The First Hospital of Lanzhou University

    RECRUITING

    Lanzhou, Gansu, China

  • The First People's Hospital of Yunnan Prevince

    RECRUITING

    Kunming, Yunnan, China

  • The Second Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • The Second Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, China

  • Tianjin Medical University General Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Xiamen Hospital of Traditional Chinese Medicine

    RECRUITING

    Xiamen, Fujian, Xiamen, China

  • Xiamen University Affiliated Zhongshan Hospital

    RECRUITING

    Xiamen, Fujian, China

  • Yichang Central People's Hospital

    RECRUITING

    Yichang, Hubei, China

  • Yichun People's Hospital

    RECRUITING

    Yichun, Jiangxi, China

  • ZhuJiang Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, China

  • Zhuzhou Central Hospital

    RECRUITING

    Zhuzhou, Hunan, China

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