Phase 2 Lupus Trial, Recruiting NCT05039619 Sponsor: Hoffmann-La Roche Condition: Lupus
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Phase 2 Lupus Trial, Recruiting

NCT05039619
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 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.

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 27 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: 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

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
12 May 2022
Est. completion
15 June 2028

Where this trial is recruiting

🇧🇷 Brazil 🇨🇦 Canada 🇫🇷 France 🇮🇹 Italy 🇲🇽 Mexico 🇵🇪 Peru 🇵🇱 Poland 🇷🇺 Russia 🇿🇦 South Africa 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

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?

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: 27 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