Evaluating a new treatment for systemic lupus erythematosus

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 clinical trial aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-2173, administered through multiple subcutaneous injections, in patients diagnosed with systemic lupus erythematosus (SLE). The study will involve participants aged 18 to 65 who have had a confirmed diagnosis of SLE for at least 12 weeks. By closely monitoring the effects of the treatment, researchers hope to gather valuable data on how SHR-2173 interacts with the body and its potential therapeutic benefits for SLE patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-65 years, regardless of gender;
2. Weight ≥45.0 kg at screening;
3. Confirmed SLE diagnosis for ≥12 weeks at screening.

Exclusion Criteria:

1. Pregnant or breastfeeding women, or those with a positive human chorionic gonadotropin (HCG) test.
2. History of alcohol abuse or illegal drug use within one year prior to screening.
3. Blood donation ≥450 mL within 8 weeks prior to screening or plans to donate blood during the study.
4. Current active infection or a history of active tuberculosis
5. Other inflammatory or autoimmune diseases beyond SLE and LN that may interfere with the interpretation of trial results or clinical assessment.

Where it's running

• Renji Hospital affiliated to Shanghai Jiaotong
  Shanghai, Shanghai, China Recruiting

Study contacts

• Study coordinator: Zhe Zhang
• Email: zhe.zhang@hengrui.com
• Phone: +0518-81220121

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Biomarker tests in adults with lupus to see how kidney disease changes over time

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• Sirolimus added to standard therapy for adults with SLE-associated immune thrombocytopenia

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  Recruiting Phase 2/3 Chinese SLE Treatment And Research Group · Beijing, Beijing Municipality · NCT07657793

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.