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 enrolled 461 adults with lupus (systemic lupus erythematosus) across three groups: 159 people were assigned to atacicept 75 mg, 145 to atacicept 150 mg, and 157 to a placebo (a dummy treatment with no active ingredient). The trial was measuring whether atacicept reduced "flares" — periods when lupus symptoms became more active — over up to 52 weeks, using a recognised lupus scoring system called BILAG. It is worth noting that the 150 mg group had a notably higher number of people who did not complete the study (83 out of 145) compared to the other two groups. The reported data shows that, for the main outcome — the percentage of participants who experienced at least one lupus flare over the full study period — 57.3% of those in the atacicept 75 mg group had a flare, compared with 36.1% in the atacicept 150 mg group and 53.3% in the placebo group. For a related secondary measure looking at only the first 24 weeks, the reported figures were 40.1% (75 mg), 28.5% (150 mg), and 35.1% (placebo). The reported data also shows that the earliest point at which 25% of participants had experienced their first flare was around day 143 in the 75 mg group, day 310 in the 150 mg group, and day 142 in the placebo group (the midpoint was not reached in any group within the study timeframe). The mean total corticosteroid dose — a type of medication often used to manage lupus flares — was reported as approximately 2,457 mg for the 75 mg group, 2,019 mg for the 150 mg group, and 2,624 mg for the placebo group. 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 ↗ · Read the linked publication on PubMed (PMID 37332136) ↗
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 are 16 years of age or older (male or female)
- You have been diagnosed with lupus (SLE) for at least six months, meeting at least 4 out of 11 standard lupus diagnostic criteria
- Your lupus is currently active and flaring in a way that requires a change in your steroid medication dose
- A specific blood test (ANA or anti-dsDNA) came back positive at your screening appointment
- If you are female, you must be willing to use a reliable form of birth control starting 4 weeks before the trial begins, throughout the trial, and for 24 weeks after your last dose of the study medication
- Other criteria defined by the trial may also apply (confirm with trial site)
Who may not be able to join:
- You have active moderate to severe kidney problems related to your lupus (confirm with trial site for exact definition)
- You have serious or worsening lupus affecting your brain or nervous system that affects your thinking or ability to understand and follow the study requirements
- You have previously been treated with rituximab, abatacept, or belimumab (specific medications used in autoimmune conditions)
- You have a history of a condition that affects the protective coating of your nerves, such as multiple sclerosis (MS) or optic neuritis
- Other criteria defined by the trial may also apply (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 Responsible, Merck KGaA, Darmstadt, Germany
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
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B
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.