QLG1074 for Active Lupus Nephritis

A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis

Recruiting Phase 3 Interventional Study
Lupus Nephritis
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
270 (estimated)
Sponsor
Qilu Pharmaceutical Co., Ltd. · Industry
Who this trial is looking for

This trial is looking for adults aged 18 to 75 who have active lupus nephritis. Participants will receive QLG1074 and continue taking their current therapies for a year to see how it works for their kidney health.

Are You a Good Fit for This Trial?
Must be taking MMF
Rules you out Severe cardiovascular diseaseSevere viral infectionActive tuberculosisLymphoproliferative disease

You may be able to join if

  • I am between 18 and 75 years old.
  • I have systemic lupus erythematosus (SLE).
  • I have evidence of active nephritis.
  • I need high-dose corticosteroids and immunosuppressive therapy.
  • I am willing to take oral MMF for the duration of the study.
  • I have given written consent.

You may not be able to join if

  • I have an estimated glomerular filtration rate of 45 mL/min or less.
  • I require dialysis or have had a kidney transplant.
  • I have a known allergy to MMF, cyclosporine, or corticosteroids.
  • I have a current or past history of severe viral infections.
  • I have other serious health conditions affecting my heart, liver, or lungs.
  • I am pregnant or breastfeeding.
  • I participated in another trial in the last 4 weeks.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

The purpose of this study is to assess the efficacy of QL1074 compared with placebo in achieving renal response after 52 weeks of therapy in subjects with Active Lupus Nephritis.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Written informed consent before any study-specific procedures are performed. 2. Male or female subjects with a minimum age of 18 (or legal age of consent if \>18 years) to 75 years of age, inclusive, at the time of screening (Visit 1). 3. Previous diagnosis of systemic lupus …
Contacts

Feng Guo

0531-55821177

feng11.guo@qilu-pharma.com

CONTACT