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 drug called BI 655064, tested at three different doses (120 mg, 180 mg, and 240 mg), compared against a placebo (an inactive treatment) in people with lupus nephritis — a condition where lupus causes kidney inflammation. A total of 69 people took part across all four groups. The main thing the trial was measuring was the proportion of participants who achieved what researchers called a "complete renal response" — meaning their urine protein levels dropped to a low level and their kidney function either stayed in the normal range or did not decline much — and who also had no kidney flare-ups (sudden worsening of kidney symptoms) over 52 weeks. The reported data shows that, for the primary outcome, the adjusted (statistically fine-tuned to account for differences between participants) percentages achieving a complete renal response without any kidney flares were: 51.8% in the 120 mg group, 48.2% in the 180 mg group, 59.5% in the 240 mg group, and 57.5% in the placebo group. For the secondary outcomes, when looking at a stricter definition of response confirmed at two separate time points, the reported figures were 42.9% (120 mg), 30.8% (180 mg), 50.0% (240 mg), and 52.0% (placebo). The proportion of participants who experienced at least one kidney flare during the 52 weeks was 0% in the 120 mg group, 21.4% in the 180 mg group, 0% in the 240 mg group, and 16.0% in the placebo group. For those who did have a flare, the reported average time to the first flare was 36 weeks in the 180 mg group and 37.5 weeks in the placebo group; this figure was not reported for the other 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 2 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:
- Both men and women may be eligible to participate.
- Women who could become pregnant and men who could father a child must be willing and able to use two reliable forms of birth control at the same time (at least one must be highly effective), starting before the trial medications, continuing throughout the trial, and for at least 50 days after the last dose (or 90 days if treated with a medication called Azathioprine).
- Sexually active men must be willing to use condoms during treatment and for at least 90 days after stopping the trial medications.
- Women who have gone through menopause (defined as no periods for 12 months with no other medical reason) or who have had a permanent sterilisation procedure (such as removal of the uterus, both ovaries, or both fallopian tubes) may not need to use birth control (confirm with trial site).
- You must be willing and able to sign a consent form before joining the trial.
- For one specific group in the trial: you must have shown a certain level of kidney improvement at the end of a previous related study (confirm with trial site which group applies to you).
Who may not be able to join:
- People who have significant health conditions or medical findings other than lupus that the trial doctor feels could affect their safety or the reliability of the trial results.
- People who have significant symptoms affecting the brain or nervous system related to their lupus, as judged by the trial doctor.
- People who have a serious active or ongoing infection, including HIV, hepatitis B, or hepatitis C.
- People whose liver is not working well enough, based on specific blood test results (confirm with trial site).
- People whose kidneys are not filtering well enough, based on a specific blood test measurement falling below a set level (confirm with trial site).
- People who are allergic to any of the trial medications, or for whom the trial medications (MMF, Azathioprine, or steroids) are medically unsuitable.
- People who are taking certain other medications that could interfere with the trial or affect safety (confirm with trial site which medications are restricted).
- People who, in the trial doctor's opinion, would be unable to follow the trial requirements.
- People with ongoing problems with alcohol or drug misuse, or any condition that the trial doctor feels would make them unlikely to complete the trial reliably.
- Women who are currently pregnant, breastfeeding, or planning to become pregnant during the trial.
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
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
Percentage of Patients With Complete Renal Response (CRR) and Without Any Renal Flares
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.