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Nipocalimab for Lupus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Twoja Przychodnia Poznanskie Centrum Medyczne, Poznan, PolandLupusNipocalimab - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Lupus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
BIIB059
1
Deucravacitinib
1
LY3361237

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Up to Week 58

Up to Week 24
Percentage of Participants Receiving >= 10 milligram/day (mg/day) Prednisone or Equivalent at Baseline who Achieve Week 6-16 Glucocorticoid (GC) Taper Goal (at Week 16 to <= 7.5 mg/day Prednisone or Equivalent) and Maintain that Reduction Until Week 24
Time to First Flare Through Week 24
Up to Week 58
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
Percentage of Participants with Treatment-emergent AEs leading to treatment discontinuation Through Week 58
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) Through Week 58
Percentage of Participants with Treatment-emergent Adverse Events of Special interests (AESIs) Through Week 58
Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs) Through Week 58
Serum Concentration of Nipocalimab Over Time
Week 24
Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 24
Percentage of Participants Achieving the British Isles Lupus Assessment Group (BILAG) Composite Lupus Assessment (BICLA) Response at Week 24
Percentage of Participants with >= 4 Point Improvement in SLE Disease Activity Index 2000 (SLEDAI-2K) at Week 24
Percentage of Participants with Baseline Active Mucocutaneous Lupus Manifestations (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI] Activity Score >= 6) Achieving >= 50 Percent (%) Reduction in the CLASI Activity Score at Week 24
Percentage of Participants with Baseline Arthritis (with at Least 4 Active Joints at Baseline) Achieving >= 50% Reduction in Active Joints at Week 24
Week 52
Percentage of Participants Achieving SRI-4 Composite Response at Week 52

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
BIIB059
2
Deucravacitinib
2
LY3361237

Trial Design

3 Treatment Groups

Group 2: Nipocalimab Dose 1
1 of 3
Group 3: Nipocalimab Dose 2
1 of 3
Group 1: Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

225 Total Participants · 3 Treatment Groups

Primary Treatment: Nipocalimab · Has Placebo Group · Phase 2

Group 2: Nipocalimab Dose 1Experimental Group · 2 Interventions: Nipocalimab, Standard-of-care treatment · Intervention Types: Drug, Drug
Group 3: Nipocalimab Dose 2Experimental Group · 2 Interventions: Nipocalimab, Standard-of-care treatment · Intervention Types: Drug, Drug
Group 1: PlaceboPlaceboComparator Group · 2 Interventions: Standard-of-care treatment, Placebo · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nipocalimab
Not yet FDA approved
Standard-of-care treatment
2018
Completed Phase 2
~160

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 58

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
934 Previous Clinical Trials
6,369,006 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
717 Previous Clinical Trials
3,951,147 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Georgia100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Hosp. de Navarra100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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