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 (NCT03943147) looked at a combination of two medicines — mycophenolate mofetil (MMF) and an investigational drug called BMS-986165 — in people with lupus nephritis, a condition where lupus causes kidney inflammation. The trial ran in two parts: an open-label run-in phase (Part A, where everyone received MMF alone) and a blinded treatment phase (Part B, where a small number of participants also received BMS-986165). In total, 16 participants started Part A, but only 6 completed it. Of those, just 1 participant ended up in the MMF plus BMS-986165 group in Part B, and that single participant completed Part B. Because so few people progressed through the trial, the numbers reported are based on very small groups. The reported data shows the following results for the one participant who received the combination treatment in Part B. On the primary outcomes: 1 out of 1 participant experienced an adverse event (an unexpected or worsening medical occurrence during the study); 0 out of 1 had clinically significant abnormal heart-tracing (ECG) results; and 0 out of 1 had clinically significant abnormal blood or urine lab results. Vital signs (blood pressure, heart rate, breathing rate, and temperature) showed percentage changes from their starting values ranging from roughly −3.5% to +16.9%, though the specific vital sign each figure belongs to was not individually labelled in the reported data. The reported data also shows that the level of protein relative to creatinine in a 24-hour urine sample — a marker used to assess kidney function — changed by approximately −34.9% from the starting point to week 24. On the secondary outcome, 0 out of 1 participants met the definition of a "partial renal response," which was set as a 50% or greater reduction in that same urine protein measure. It is important to note that because only one participant completed the combination-treatment phase, these numbers reflect the experience of a single person and cannot be used to draw broader conclusions. The trial appears to have stopped well short of its intended enrolment, and the reasons for participants not completing the study were not detailed in the reported data. 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 have been diagnosed with Systemic Lupus Erythematosus (SLE, also called Lupus) based on a specific set of recognised medical standards.
- A kidney biopsy has confirmed that you have an active form of Lupus Nephritis (kidney inflammation caused by Lupus) of a certain type (classified as Class III, IV-S, IV-G, or Class V).
- A urine test shows that your kidneys are leaking a certain amount of protein above a specified level (confirm with trial site for exact measurement details).
Who may not be able to join:
- You have a specific type of Lupus Nephritis called "pure Class V membranous Lupus Nephritis" on its own, without other types present.
- Your kidneys are not functioning well enough, based on a blood test that measures how well your kidneys filter waste (confirm with trial site for exact level).
- You have been on dialysis (a machine that does your kidneys' job) at any point in the 12 months before joining, or you are expected to need dialysis within 6 months of joining the trial.
- You have end-stage kidney disease, meaning your kidneys have permanently stopped working properly.
Important: Always verify eligibility with the trial site directly before applying.
Note: Additional eligibility requirements not listed here may also apply — the trial team will review your full medical history.
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: Bristol-Myers Squibb, Bristol-Myers Squibb
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
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (Part B); The Number of Participants With Clinically Significant ECG Abnormalities in the Blinded Treatment Period (Part B); The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B); The Number of Participants With Abnormal Laboratory Parameters of Clinical Significance in the Blinded Treatment Period (Part B); Percent Change From Baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR) at Week 24 in the Blinded Treatment Period (Part 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.