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 tested a medicine called BMS-986165 (at three different doses: 3 mg, 6 mg, and 12 mg daily) compared to a dummy pill (placebo) in people with systemic lupus erythematosus (lupus). A total of 363 people took part — 90 in the placebo group, 91 in the 3 mg group, 93 in the 6 mg group, and 89 in the 12 mg group. The main thing the trial was measuring was how many people met a standard set of criteria showing their lupus had improved by week 32. This is called the SRI(4) score, which combines three separate assessments of disease activity rated by both the patient and their doctor. The reported data shows that at week 32 (the main measurement point), 31 out of 90 people in the placebo group met the improvement criteria, compared with 53 out of 91 in the 3 mg group, 46 out of 93 in the 6 mg group, and 40 out of 89 in the 12 mg group. The reported data also shows similar patterns at week 48, where the numbers were 31 (placebo), 52 (3 mg), 44 (6 mg), and 42 (12 mg). For other measures — including a different lupus improvement score (BICLA), a "low disease activity" rating, and a skin-specific score in people who had significant skin involvement at the start — the reported numbers were also higher in the treatment groups compared to placebo. For joint counts (a measure of tender and swollen joints), all four groups reported reductions from their starting scores, with the changes being broadly similar across 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 ↗ · Read the linked publication on PubMed (PMID 40451616) ↗
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:
- You have been diagnosed with Systemic Lupus Erythematosus (SLE), commonly known as lupus, for at least 24 weeks before the screening visit.
- Your lupus diagnosis meets a specific set of recognized international classification guidelines for lupus (confirm with trial site).
- A blood test shows at least one of the following: a positive ANA test at a certain level (1:80 or higher), a positive anti-dsDNA result (including borderline/uncertain results), or a positive anti-Smith antibody — as confirmed by the trial's central laboratory.
- Your lupus disease activity score, measured by a specific medical tool called SLEDAI-2K, is above a certain threshold and includes symptoms involving your joints and/or skin rash — this must be confirmed by a central review team.
- If you are able to have children, you must be willing to use specific methods of birth control during the trial, if required.
Who may not be able to join:
- Your lupus was caused by a medication (drug-induced lupus), you have certain other autoimmune conditions, or you have a severe, active form of lupus affecting your kidneys.
- You have a lupus "overlap syndrome," meaning your lupus occurs alongside conditions such as scleroderma or mixed connective tissue disease.
- Your chest X-ray or heart tracing (ECG) shows significant abnormalities.
- You have a history of a serious allergic reaction to a medication.
- There are additional eligibility requirements not 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: 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
Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32
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.