GARDENIA
GARDENIA is a national study that evaluates how well the new drug nipocalimab works in participants with moderate to severe systemic lupus erythematosus (SLE).
About This Study
Summary
Systemic lupus erythematosus (SLE) occurs when the body’s immune system mistakenly attacks its own healthy tissues. This autoimmune disease can lead to inflammation and damage at many sites, including the skin, joints, heart, lungs, kidneys, and brain. Upward of 5 million people in the world have SLE, making it the most common form of lupus. In addition, SLE affects women 9 times more often than men.
SLE is a chronic disease, with symptoms that include severe fatigue, pain, swelling, and rashes. Widespread inflammation and disease flares as well as the need to rely on long-term steroids for treatment put patients with SLE at risk for permanent organ damage. In addition, these factors can significantly reduce quality of life, highlighting the need for more treatment options.
The GARDENIA study evaluates how well nipocalimab works in participants with moderate to severe SLE. Participants in GARDENIA are assigned randomly (50:50, like tossing a coin) to either receive nipocalimab or a placebo (something that looks like the study compound but doesn’t contain any medicine). Neither the lead investigator nor the study participant can choose which treatment they receive. Regardless of which study treatment they receive, all participants will continue to receive standard of care therapy for their SLE.
To be included in GARDENIA, participants must be / have
- Adults (18 years old or older)
- Medically stable according to physical examination, medical history, vital signs (temperature, pulse, number of breaths per minute, etc.), and heart activity (EKG) at time of screening
- Clinically diagnosed with SLE at least 24 weeks prior to screening
- SLE disease activity considered to be moderate to severe according to standard clinical guidelines
To be included in GARDENIA, participants must not be / have
- Severe, progressive, or uncontrolled liver, gastrointestinal, kidney, lung, heart or blood vessel, mental health, nerve, muscle, or bone disorder
- Severe or uncontrolled high blood pressure
- Severe, uncontrolled, or progressive SLE or other autoimmune disorder
Keywords
Autoimmune disease; Lupus; SLE
For More About This Study or To Ask About Participation
Additional Information
Lead scientist at Carilion clinic
Official title of study
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus (GARDENIA)
Funding mechanism
Industry sponsored by Janssen Research & Development