626 added to standard treatment for systemic lupus (SLE)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 interventional trial adds the investigational drug 626 to patients' existing standard-of-care SLE medications and compares outcomes with a placebo plus standard care group. Eligible adults (18–70 years) must have a confirmed SLE diagnosis of at least six months, active disease (SLEDAI-2K ≥6 and clinical score ≥4), and be on at least one SOC medication. The study will track clinical disease activity and safety measures across treatment arms to determine whether 626 improves outcomes or has concerning adverse effects. Key study procedures require in-person visits at the study site for dosing, monitoring, and laboratory testing.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Qinghong Zhou
• Email: zhouqinghong@3sbio.com
• Phone: +86 18911301578

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.