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 (NCT01930890) enrolled 87 people in total across four groups. All participants had previously taken part in an earlier related study and continued into this follow-on phase receiving either a lower dose (3 mg/kg) or a higher dose (20 mg/kg) of the investigational medicine BIIB023, or had switched to one of those doses after previously receiving a dummy treatment (placebo). The trial's main focus was on tracking and counting any unwanted medical events — called adverse events (AEs) — and any serious adverse events (SAEs), which are more severe medical occurrences such as hospitalisation or life-threatening events. The reported data shows that across the four groups, the number of participants who experienced any adverse event ranged from 4 out of 14 people in the placebo-then-lower-dose group, up to 23 out of 33 people in the group who received the lower dose throughout both studies. For serious adverse events, the numbers reported were 2, 12, 3, and 6 participants across the four groups respectively. Deaths were reported for 0, 4, 1, and 3 participants across the groups. Regarding people who stopped treatment or left the study because of an adverse event, the reported data shows that most groups recorded zero such participants, with 2 people in the ongoing lower-dose group and 1 person in the ongoing higher-dose group recorded as having done so. 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 2 Lupus Trial, Terminated
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 must have completed Week 52 of a previous related study called Study 211LE201 (NCT01499355) without stopping your assigned treatment (either the study drug or placebo).
- If you are someone who could become pregnant, you must be willing and able to use effective birth control throughout the study and for 6 months after your last dose of the study treatment.
Who may not be able to join:
- If your health has changed significantly since the previous study — including new medical conditions or abnormal test results — the trial doctor may decide you are no longer suitable to participate.
- If you stopped taking the study drug or placebo before reaching Week 52 in the previous related study, you would not be eligible.
- You cannot join if you are currently pregnant, breastfeeding, or planning to become pregnant during the study.
- If you are unwilling or unable to follow the study's requirements, or if any physical, mental, or social condition might make it difficult for you to do so, you may not be eligible.
- The trial doctor or the study sponsor may decide you are not suitable for the trial for other reasons not specifically listed here (confirm with trial site).
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: Medical Director, Biogen
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
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs); Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.