Nipocalimab for Systemic Lupus Erythematosus

(GARDENIA Trial)

Recruiting at 68 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Disqualifiers: Uncontrolled autoimmune disorders, Immunodeficiency, Severe allergies, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).

Are You a Good Fit for This Trial?

Inclusion Criteria

Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test at screening and a negative urine (β- hCG) test at Week 0 prior to randomization

Has at least 1 BILAG-2004 A score or 2 BILAG-2004 B scores observed at screening

I am medically stable based on recent exams and heart tests.

Exclusion Criteria

I do not have any severe or uncontrolled major health problems.

My lupus is stable and does not need stronger treatment than my current medications.

I do not have an immune deficiency or a family history of inherited immune problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nipocalimab or placebo along with standard of care treatments for 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Eligible participants may continue to receive nipocalimab until Week 156 or until the study intervention is discontinued

104 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nipocalimab

How Is the Trial Designed?

Group I: Nipocalimab Experimental Treatment 2 Interventions

Participants will receive nipocalimab up to Week 52 in the double blind treatment period along with standard of care treatments. At Week 52, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.

Group II: Placebo Placebo Group 3 Interventions

Participants will receive placebo up to Week 52 in the double blind treatment period along with standard of care treatment. At Week 52, eligible participants from both studies will have the option to enter an OLE period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University