Phase 2 Lupus Trial, Recruiting NCT05268289 Sponsor: Novartis Pharmaceuticals Condition: Lupus
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Phase 2 Lupus Trial, Recruiting

NCT05268289
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 have had a blood test showing positive results linked to lupus (called ANA and/or anti-dsDNA tests).
  • You have been diagnosed with a specific type of kidney inflammation caused by lupus (called lupus nephritis Class III or IV, with or without Class V), confirmed by a kidney biopsy taken within the last 3 months.
  • Your kidney disease is currently active and your doctor has decided you need to start treatment with steroids combined with a specific medication (MMF/MPS).
  • Your kidneys are still functioning at a reasonable level, based on a blood test measuring kidney function (eGFR of 30 or above).
  • You have received vaccines to protect against certain bacterial infections (Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae).
  • You are already receiving appropriate supportive care, which may include anti-malarial tablets (like hydroxychloroquine) and/or blood pressure medications (ACEi or ARB), unless these are not suitable for you.
  • This is either your first time being diagnosed with lupus nephritis, or you are experiencing a flare-up of a previous diagnosis.

Who may not be able to join:

  • You have received a strong chemotherapy-type treatment called cyclophosphamide for lupus in the last 3 months, or a type of medication called calcineurin inhibitors in the last 3 months before joining.
  • Your kidney function has dropped very rapidly (by 50% or more) in the last 3 months, which indicates a severe form of kidney disease.
  • Your kidney biopsy shows significant permanent scarring (more than 50%), or your doctor believes your kidneys are unlikely to respond to immune-suppressing treatment.
  • You are currently taking steroid tablets (more than 5 mg/day of prednisone or equivalent) for a condition other than lupus, such as asthma or inflammatory bowel disease.
  • You have been taking relatively high doses of steroid tablets for lupus recently — specifically more than an average of 15 mg/day over the past 4 weeks, or more than 30 mg/day over the past week.
  • You have received more than a total of 1,000 mg of high-dose steroid given through a drip (IV) in the 2 weeks before joining the trial.
  • There may be additional criteria not listed here that could affect your eligibility (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 21 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

Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Phone: 1-888-669-6682

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
Registry
ClinicalTrials.gov
Start date
10 August 2022
Est. completion
19 March 2026

Where this trial is recruiting

🇦🇷 Argentina 🇧🇷 Brazil 🇨🇳 China 🇨🇴 Colombia 🇫🇷 France 🇩🇪 Germany Hong Kong 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇲🇾 Malaysia 🇲🇽 Mexico 🇵🇭 Philippines 🇵🇹 Portugal Puerto Rico 🇸🇬 Singapore 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flares

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: 21 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