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 (NCT03616912) enrolled 830 participants across six groups to study baricitinib — a medicine taken as a daily tablet — in people with systemic lupus erythematosus (lupus). The main question the trial was trying to answer was whether a 4 mg daily dose of baricitinib led to more people achieving a recognised measure of lupus disease improvement (called an "SRI-4 response") compared with a placebo (dummy pill). A 2 mg daily dose and several other disease measures were also tracked as secondary questions. Participants were followed for up to 52 weeks. The reported data shows that, for the primary question, 56.7% of participants taking 4 mg baricitinib met the SRI-4 response criteria, compared with 45.9% in the placebo group. For the 2 mg dose (a secondary measure), 49.8% met the same criteria versus the same 45.9% placebo figure. On a separate measure called "low disease activity state," the reported figures were 25.7% (2 mg), 29.7% (4 mg), and 26.2% (placebo). For steroid reduction (cutting the steroid dose by at least 25% down to a low level), the reported percentages were 29.2% (2 mg), 34.0% (4 mg), and 30.8% (placebo). For self-reported worst pain (on a 0–10 scale, where lower is better), average scores dropped by 1.73 points (2 mg), 1.71 points (4 mg), and 1.62 points (placebo) from the start of the trial. The data for "time to first severe flare" was not reported in the submitted results. 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 40305472) ↗
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, 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/lupus) for at least 24 weeks before the screening visit.
- Your diagnosis meets at least 4 out of 11 specific classification criteria for lupus, as defined by a major rheumatology organization (confirm with trial site).
- Blood tests taken during screening show certain markers linked to lupus activity (specific antibodies known as ANA, anti-dsDNA, or anti-Smith).
- Your lupus disease activity score, measured by a standard medical tool, is at a certain level of severity during screening (confirm with trial site).
- Your lupus disease activity remains at a required level of severity at the point you are enrolled into the trial (confirm with trial site).
- Your lupus symptoms meet a minimum severity threshold based on another standard assessment tool used by doctors (confirm with trial site).
- You are already taking at least one standard lupus medication — either an antimalarial drug, an immunosuppressant, or a steroid tablet — at a stable dose for a set period of time before screening.
Who may not be able to join:
- You have severe active lupus that is seriously affecting your kidneys.
- You have active lupus that is affecting your brain or nervous system.
- You have a serious or unstable medical condition affecting your heart, lungs, liver, digestive system, hormones, blood, or nervous system that the doctor believes could make participation unsafe or affect the trial results.
- You currently have, or have recently had, a serious infection caused by a virus, bacteria, fungus, or parasite.
- You have received a specific type of strong chemotherapy drug (cyclophosphamide or similar cytotoxic agents) within the 12 weeks before screening.
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: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
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
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.