Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called epratuzumab, given to people with lupus (a disease where the immune system attacks the body). A total of 1,250 participants were enrolled across three groups, receiving either epratuzumab at 600 mg per week or 1,200 mg every two weeks, over a treatment period of up to 96 weeks (about two years). The trial was primarily measuring how many participants stopped taking the medicine early because of an unwanted medical event (called a treatment-emergent adverse event, or TEAE), and how many experienced a serious adverse event (SAE) — meaning a medical event considered serious enough to require hospitalisation or other significant intervention. A secondary measure looked at how many participants met a combined set of criteria suggesting their lupus activity had improved. The reported data shows that across all participants, 96 out of 1,250 (about 7.7%) stopped treatment early due to a TEAE. When broken down by group, this was approximately 10.7% in the Cohort 1 group receiving 600 mg per week, 9.1% in the Cohort 2 group receiving 1,200 mg every two weeks, and 4.9% in the Cohort 2 group receiving 600 mg per week. Regarding serious adverse events, the reported data shows that 304 out of all participants (about 24.4%) experienced at least one SAE during the treatment period. For the secondary outcome — meeting the combined response criteria for lupus activity — 362 out of all participants (approximately 29.9%) were reported as meeting those criteria. It is worth noting that the vast majority of participants did not complete the overall study period, and completion data was only recorded for one of the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Lupus Trial, Completed
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 previously took part in one of the related studies (SL0009 or SL0010) and either finished it, or left at week 16 or later because the treatment wasn't working well enough — and your doctor thinks you could still benefit from continuing the treatment
- You previously completed one of the earlier related studies (SL0006 or SL0008), and your doctor thinks you could still benefit from continuing the treatment
- If you are a woman who could become pregnant, you must be willing to use an acceptable form of birth control during the trial
Who may not be able to join:
- People whose lupus is seriously affecting their brain or mental health (confirm with trial site)
- People whose lupus is currently causing serious problems with their kidneys
- People who have certain ongoing health conditions, including some types of chronic infections or a high risk of developing a serious new infection
- People who currently misuse or are dependent on alcohol or drugs
- People who have had cancer at any point in the past
- People who have any other health condition that, in the doctor's opinion, would make it unsafe or unsuitable for them to take part
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.
Contact this trial
Principal Investigator: UCB Clinical Trial Call Center, UCB Pharma
Australian sites
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
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks); Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks); Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks); Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.