Phase 2 Lupus Trial, Recruiting
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 between 12 and under 18 years old at the time of joining the trial (a younger group for children aged 5 to under 12 may also open later — the trial site can advise on this)
- A kidney biopsy taken in the last 12 months (or during screening) shows a specific type of active lupus kidney disease known as Class III or IV (confirm with trial site)
- Class V lupus kidney disease may also be present alongside Class III or IV, but having Class V alone does not qualify
- You have been diagnosed with lupus (SLE) based on recognised 2012 medical guidelines
- A urine test during screening shows a significant level of protein in your urine (above a certain threshold from a first morning sample)
- In the 12 months before or during screening, you have received at least one high-dose steroid treatment given through a drip (IV) for your current lupus kidney flare
Who may not be able to join:
- You have severe, active lupus affecting your brain or nervous system, such as uncontrolled seizures, stroke, confusion, or other serious neurological problems
- Your kidney biopsy shows that more than half of the kidney's filtering units have permanent scarring
- Your kidney biopsy shows only long-term (chronic) damage with no signs of active disease
- You have a rapidly worsening form of kidney disease (confirm with trial site)
- You have only Class V lupus kidney disease with no Class III or IV involvement
- You cannot tolerate or have a medical reason to avoid the study medications
- You have an active infection of any kind, have been hospitalised for an infection in the past 4 weeks, or finished a course of antibiotic/antiviral tablets within the past 2 weeks (nail fungal infections are excluded from this rule)
- You have a known condition that weakens the immune system, including HIV or other serious immune or blood disorders
- You have a history of serious, repeated, or long-lasting infections
- You have had cancer of any type in the past 5 years (certain treated skin cancers may be exceptions — confirm with trial site)
- You have another serious or uncontrolled health condition that the trial doctor believes would make participation unsafe
- You currently misuse alcohol or drugs, or have a history of doing so
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.
Contact this trial
Principal Investigator: Clinical Trials, Hoffmann-La Roche
Phone: 888-662-6728 (U.S. and Canada)
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
Where this trial is recruiting
Primary endpoints
Percentage of Participants who Achieve a Complete Renal Response (CRR) (AP); Percentage of Participants with Adverse Events (PP)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.