Phase 3 study for people with Lupus
Recruiting Phase 3
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| BOX HILL | Box Hill | VIC | Recruiting |
| Footscray Hospital, Western Health | Footscray | VIC | Recruiting |
| Ipswich Hospital | Ipswich | QLD | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion Criteria:-
* Medically stable on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening
* Clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to (\>=) 24 weeks prior to screening and meeting european league against rheumatism/american college of rheumatology (EULAR/ACR) classification criteria
* Must have a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score \>= 6 and a clinical SLEDAI-2K \>= 4 at screening, AND a clinical SLEDAI-2K score \>= 4 points at Week 0. For eligibility, points attributed to "lupus headache," "alopecia," and "organic brain syndrome" are excluded
* Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test at screening and a negative urine (β- hCG) test at Week 0 prior to randomization
* Has at least 1 BILAG-2004 A score or 2 BILAG-2004 B scores observed at screening
Exclusion Criteria:
* History of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder (s) or clinically significant abnormalities in screening laboratory
* Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications
* Confirmed or suspected clinical immunodeficiency syndrome not related to treatment of SLE or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
* Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins
* Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the placebo formulation
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 25 September 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.