Plain-English translation of NCT05835310 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing a medication called to see if it can help children and teenagers with moderate to severe systemic lupus erythematosus (lupus)—an autoimmune disease where the body's immune system attacks its own tissues. Half of the participants will receive the new medication through IV infusions every 4 weeks, while the other half will receive a placebo (a fake treatment that looks the same). Researchers want to understand how safe and effective this treatment is for young people with lupus.
Lupus in children and teens can be serious and hard to control with existing treatments alone. This study exists to find out whether this medication might help more young people manage their lupus better and reduce symptoms and flares.
You likely qualify if…
You likely don't qualify if…
You will be in this study for about 2 years (116 weeks). You'll start with a screening visit, then receive either the new medication or placebo through an IV infusion every 4 weeks for the first 1–2 months. After that, you'll continue infusions for up to a year while researchers check how well the treatment works and track any side effects through regular visits. Finally, there's a 1-year follow-up period where you'll receive the actual medication (not placebo), plus a final safety check visit 12 weeks after your last dose.
AI-generated summary from trial data · Jul 19, 2026 · Not medical advice
United States