SLE-BRAVE research program
A study looking for people with lupus to find out if an investigational oral treatment is effective
Protocols I4V MC JAHZ / I4V-MC-JAIA
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus
Eli Lilly & Company
The aim of the SLE-BRAVE program is to determine whether baricitinib, combined with standard lupus therapy, can help in the treatment of lupus (people with active lupus nephritis and active lupus that affects the central nervous system are excluded). It also will look at the safety of baricitinib and determine if there are any additional side effects.
What Does this Study Involve?
- If you are eligible for the study and decide to participate, you will receive either the study drug or a placebo that will be taken orally every day for up to 1 year
- At each study visit, your weight, heart rate, blood pressure, and body temperature will be taken to check your health and see how you are responding to the study drug
- You will also be asked to fill out a patient diary and questionnaires
- Your total participation will be about 62 weeks (approximately 14 months)
- If you complete this study, you may be eligible to participate in the long-term extension study in which all participants receive the active study drug
To consider participation in this study you must:
- Be at least 18 years of age
- Have active lupus disease and may be taking some medications for your lupus, which your study doctor will discuss with you
- Be willing and able to give consent to take part in the trial
- Be able to visit the study doctor as required
You cannot participate in the study, if you have any of the following:
- Severe lupus complications involving your kidneys or nervous system
- Been treated for another autoimmune condition within the past 12 weeks
- Have or have had another serious medical condition
- Have or have had a current or recent serious infection
- Received certain medications to treat your lupus within 12 weeks prior to screening
- Phase 3 study
- Global – more than 25 countries are taking part
- Multicenter – more than 340 clinical sites are taking part
- Double-blind - neither you nor your study doctor will know what study treatment you receive
- Placebo-controlled – you will receive either low-dose baricitinib, high-dose baricitinib, or a placebo (with no active ingredients)
Learn more and see if you qualify at slebrave.com.
There are two trials available in the US. Find a site near you at Lilly Trial Guide SLE-BRAVE JAHZ and Lilly Trial Guide SLE-BRAVE JAIA.