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:

• You are 16 years of age or older (18 or older if you are in China) at the time you sign the consent form
• You have been diagnosed with Systemic Lupus Erythematosus (SLE — a chronic immune system disease) by a qualified doctor for at least 24 weeks before the screening visit
• Your SLE diagnosis meets a specific set of recognised international classification standards (confirm with trial site)
• Your blood tests at screening show certain markers of SLE activity, such as specific antibodies or low levels of certain proteins called complements (confirm with trial site)
• Your SLE is currently moderately to severely active, meaning it scores above certain thresholds on standard medical measurement tools used to assess lupus activity (confirm with trial site)
• Your SLE is active despite being on a stable dose of standard treatment, which may include antimalarial drugs, steroids, and/or immune-suppressing medications

Who may not be able to join:

• You have a medical or psychiatric condition (including certain lupus-related brain or nerve symptoms) that the doctor feels could affect your ability to safely take part, including any life-threatening condition
• You have had a severe allergic reaction (anaphylaxis) to injected contrast dyes, proteins derived from humans or mice, or monoclonal antibody treatments, or you have a serious latex allergy
• You have a history of cancer, with the exception of certain fully treated skin or cervical cancers as specified (confirm with trial site)
• You have a related condition such as mixed connective tissue disease, scleroderma, or an overlap of these conditions with SLE
• You have ever had HIV, certain immune deficiency conditions, or a specific virus called HTLV-1
• You currently have a significant active or latent (hidden/dormant) infection
• You have had a reactivated dormant infection or a serious opportunistic infection within the 12 weeks before the first study treatment, or you are currently taking medication to suppress such an infection
• You have received a live or live-attenuated vaccine (such as certain flu, chickenpox, or shingles vaccines) within 6 weeks before the first study treatment
• You have recently taken certain medications that are not allowed in this trial within the required washout (clearance) period (confirm with trial site for the full medication list)
• You have previously taken part in this specific study or have ever received the study drug dapirolizumab pegol (DZP) in any other study
• You have taken part in another clinical trial involving an experimental medicine within the past 12 weeks (or longer, depending on that medicine), or you are currently in another such trial
• You have advanced kidney problems, shown by very low kidney function scores, high creatinine levels in your blood, or high levels of protein in your urine (confirm with trial site for exact values)

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