← Back to Search

Monoclonal Antibodies

Nipocalimab for Lupus

Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have at least moderately active SLE, as defined as systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score >= 6 at screening visit. Must also have SLEDAI 2K >= 4 for clinical features (that is, SLEDAI-2K score excluding headache and laboratory abnormalities) present at Week 0 prior to randomization
Must be receiving 1 or more of the following protocol-permitted, systemic standard-of-care treatments prior to first administration of study intervention at a stable dose: oral glucocorticoids, antimalarial or up to 2 immunomodulatory drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 58
Awards & highlights

Study Summary

This trial will compare nipocalimab to placebo in patients with active SLE to see if it is more effective.

Who is the study for?
Adults diagnosed with systemic lupus erythematosus (SLE) for at least 6 months, meeting specific criteria including positive autoantibody tests and a certain level of disease activity. Participants must be on stable doses of standard SLE treatments but cannot have severe kidney issues or recent severe infections.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Nipocalimab compared to a placebo in adults with active SLE. Participants will continue their standard-of-care treatment while receiving either the study drug or placebo to see if there's an improvement in their condition.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions similar to other immune-modulating drugs such as infusion-related reactions, increased risk of infections, and possible impacts on blood counts or organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lupus is active, with a SLEDAI-2K score of 6 or more.
Select...
I am currently on a stable dose of glucocorticoids, antimalarials, or up to 2 immunomodulatory drugs.
Select...
I have been diagnosed with lupus for at least 6 months and meet specific lupus criteria.
Select...
I have severe skin lupus or at least 4 painful and inflamed joints.
Select...
I have a positive test for specific autoantibodies related to my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 58
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 58 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 24
Secondary outcome measures
Number of Participants with Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [Nabs])
Number of Participants with Change from Baseline in Laboratory Parameters Over Time
Number of Participants with Change from Baseline in Vital Signs Parameters Over Time
+12 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 3: Nipocalimab Dose 2Experimental Treatment2 Interventions
Participants will receive nipocalimab dose 2 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).
Group II: Group 2: Nipocalimab Dose 1Experimental Treatment2 Interventions
Participants will receive nipocalimab dose 1 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).
Group III: Group 1: PlaceboPlacebo Group2 Interventions
Participants will receive placebo intravenously (IV) every two weeks (q2w) through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and Glucocorticoids [GCs]).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nipocalimab
2022
Completed Phase 2
~420
Standard-of-care treatment
2018
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,080 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,677 Total Patients Enrolled

Media Library

Nipocalimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04882878 — Phase 2
Lupus Research Study Groups: Group 2: Nipocalimab Dose 1, Group 3: Nipocalimab Dose 2, Group 1: Placebo
Lupus Clinical Trial 2023: Nipocalimab Highlights & Side Effects. Trial Name: NCT04882878 — Phase 2
Nipocalimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04882878 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have these methods been used before in other research?

"Nipocalimab has been under investigation since 2019. The initial study, which was undertaken by Janssen Research & Development, LLC in 2019 included 111 participants. Based on the data collected Phase 2 & 3 drug approval was given. There are now 5 ongoing studies involving Nipocalimab taking place in 103 cities across 33 nations."

Answered by AI

How many people fit the profile to participate in this research project?

"In order to run this study, 225 participants that fit the required criteria must be recruited. Janssen Research & Development, LLC will manage the trial from Wolverine Clinical Trials in Santa Ana and GNP Research in Cooper City."

Answered by AI

Nipocalimab has been associated with what risks?

"Nipocalimab's safety is currently unknown as there is no data supporting efficacy, however it did receive a score of 2."

Answered by AI

Is this study being conducted at multiple sites?

"Currently, this trial is taking place at Wolverine Clinical Trials in Santa Ana, California, GNP Research in Cooper City, Louisiana, SouthCoast Research Center in Miami, Texas and 19 other locations."

Answered by AI

Is this research study open to patients who are senior citizens?

"This specific trial is only for adults aged 18 to 65. However, there are 17 other trials that cater to patients below the age of majority and 116 clinical trials for seniors."

Answered by AI

How can I sign up to be a part of this clinical trial?

"Eligible patients for this lupus erythematosus clinical trial must be aged 18 to 65 and will be selected from a pool of 225 candidates."

Answered by AI

Has Nipocalimab been previously studied for other purposes?

"There are currently 5 ongoing studies involving Nipocalimab with 2 of them in Phase 3. Most of the clinical trials for Nipocalimab are being conducted in Brazil and California, but there are a total of 628 research sites worldwide."

Answered by AI

Are patients still being enrolled in this clinical trial?

"Yes, this information is accurate. The trial was first posted on 8/20/2021 and updated as recently as 10/25/2022."

Answered by AI

Who else is applying?

What state do they live in?
California
Georgia
How old are they?
18 - 65
What site did they apply to?
Millennium Clinical Trials, LLC
Hosp. de Navarra
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Millennium Clinical Trials, LLC: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus
2021. "A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04882878.
All > Systemic Lupus Erythematosus > Lupus
~0 spots leftby May 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top