Phase 3 Lupus Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• A parent, caregiver, or legal guardian must be able to give signed consent on the participant's behalf, and the participant themselves may also need to give consent depending on local rules.
• The participant must have been diagnosed with Systemic Lupus Erythematosus (SLE — a chronic autoimmune disease) at least 3 months before joining the trial, using a recognised set of medical criteria (2019 EULAR/ACR criteria).
• At the screening stage, the participant must have moderate to severe active SLE, confirmed by a central review committee using specific disease activity scoring tools (confirm with trial site for exact score details).
• The participant must show no signs of active tuberculosis (TB), no history suggesting active TB, no recent close contact with someone who has active TB (or if there has been such contact, they must have been assessed by a TB specialist and started on treatment if needed), and no history of latent TB that was not fully treated.
• Female participants who could become pregnant must have a negative blood pregnancy test at screening and a negative urine pregnancy test before being assigned to a treatment group.
• Female participants who could become pregnant, and male participants, must agree to use contraception methods as required by the trial.

Who may not be able to join:

• People who have a known diagnosis of a different type of immune system condition related to interferon signalling (called an interferonopathy).
• People who have a history of, or are currently diagnosed with, a significant blood vessel inflammation condition (vasculitis) that is not caused by their SLE.
• Participants aged 11 and older who have a history of, or current evidence of, thoughts of suicide.
• People who have needed to take steroid tablets or injections (for reasons unrelated to SLE) for more than 2 weeks in total during the 24 weeks before joining the trial.
• People who test positive for HIV at screening.
• People who test positive for active Hepatitis B, Hepatitis C with detectable virus levels, or who have an active or recent Herpes Zoster (shingles) infection.
• People who have had a cytomegalovirus or Epstein-Barr virus infection that has not fully cleared up at least 12 weeks before joining the trial.
• People who have had a severe COVID-19 infection requiring hospitalisation, intensive care, or breathing support, or any previous COVID-19 infection with ongoing symptoms — as well as any mild or symptom-free COVID-19 infection (confirmed by a test or suspected based on symptoms).
• People who have previously been treated with anifrolumab (the study drug).
• People who have received certain B-cell depleting treatments (such as rituximab) within 26 weeks before joining the trial.
• People who have received a blood transfusion or blood products (other than albumin) within 4 weeks before joining the trial.

Important: Always verify eligibility with the trial site directly before applying.