Phase 2 Lupus Trial, Recruiting NCT07185269 Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Condition: Lupus
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Phase 2 Lupus Trial, Recruiting

NCT07185269
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are able to understand what the study involves and are willing to sign a consent form.
  • You are male or female, aged between 18 and 70 years old at the time of signing the consent form.
  • Your body weight is between 40 and 90 kg (approximately 88 to 198 lbs).
  • You have been diagnosed with lupus (SLE) by a doctor at least 6 months before the screening visit, confirmed using standard medical classification guidelines.
  • At screening, you have either a specific blood marker called ANA at a level of 1:80 or higher, or a positive result for another lupus-related antibody called anti-dsDNA (confirm with trial site if unsure which applies to you).
  • Your lupus disease activity score (measured by a tool called SLEDAI-2K) meets a minimum threshold at both the screening and baseline visits, indicating your lupus is currently active enough to qualify.
  • You are currently taking at least one standard lupus medication, such as a steroid tablet, an antimalarial drug, or an immunosuppressant.

Who may not be able to join:

  • You have been diagnosed with mixed connective tissue disease or an overlap of lupus with a condition called systemic sclerosis.
  • You have a medical or mental health condition — including certain lupus-related brain or nervous system complications — that the study doctor believes could make it unsafe or difficult for you to take part, including any life-threatening condition.
  • You currently have an active Hepatitis B, Hepatitis C, or HIV infection, as shown by a positive test at screening.
  • You have a history of cancer.
  • You have had a severe, active form of lupus affecting the kidneys in the 2 months before the baseline visit, or your kidney function or protein levels in urine fall outside the acceptable range for this trial (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +86 18911301578

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Registry
ClinicalTrials.gov
Start date
24 September 2025
Est. completion
12 August 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Number of participants with Adverse Events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov