626 added to standard treatment for systemic lupus (SLE)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ib/II Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Immunogenicity of Anti-BDCA2 Antibody SSGJ-626 in Subjects With Systemic Lupus Erythematosus
This trial will test whether adding the drug 626 to standard care reduces disease activity and is safe for adults with systemic lupus (SLE).
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 198 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07185269 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–70 with a confirmed SLE diagnosis for at least six months, active disease (SLEDAI-2K ≥6 with clinical ≥4), positive ANA or anti-dsDNA, weighing 40–90 kg, and currently taking at least one standard SLE medication are ideal candidates.
Not a fit: Patients with mixed connective tissue/overlap syndromes, those outside the age or weight limits, or those not on standard SLE medications are unlikely to be eligible or benefit from this protocol.
Why it matters
Potential benefit: If successful, 626 could help reduce lupus disease activity and flares when added to standard therapy, potentially improving symptoms and lowering risk of organ damage.
How similar studies have performed: Other immune-targeting drugs for SLE (for example, belimumab and anifrolumab) have shown benefit in some patients, but many experimental agents have had mixed results, so adding a novel agent like 626 is promising but not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Qinghong Zhou
- Email: zhouqinghong@3sbio.com
- Phone: +86 18911301578
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.