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Monoclonal Antibodies

Nipocalimab for Sjogren's Syndrome

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 36
Awards & highlights

Study Summary

This trial is testing if a new drug called nipocalimab is better than placebo at treating primary Sjogren's syndrome.

Eligible Conditions
  • Sjogren's Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) Score at Week 24
Secondary outcome measures
Change from Baseline in European League Against Rheumatism (EULAR) Sjogren Syndrome Patient Reported Index (ESSPRI) Score at Week 24
Disease Response as Assessed by Sjögren's Tool for Assessing Response (STAR) Composite Score at Week 24
Response Elements
+14 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 3: Nipocalimab Dose 2Experimental Treatment2 Interventions
Participants will receive nipocalimab dose 2 IV q2w through Week 22 along with standard of care treatments ([including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues], and/or one immunomodulator with or without low-dose glucocorticosteroids).
Group II: Group 2: Nipocalimab Dose 1Experimental Treatment2 Interventions
Participants will receive nipocalimab dose 1 IV q2w through Week 22 along with standard of care treatments ([including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues], and/or one immunomodulator with or without low-dose glucocorticosteroids).
Group III: Group 1: PlaceboPlacebo Group2 Interventions
Participants will receive placebo intravenously (IV) every 2 weeks (q2w) through Week 22 along with standard of care treatments ([including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues], and/or one immunomodulator with or without low-dose glucocorticosteroids).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nipocalimab
2022
Completed Phase 2
~420
Standard of Care Treatment
2016
Completed Phase 3
~410

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
977 Previous Clinical Trials
6,384,537 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
746 Previous Clinical Trials
3,960,115 Total Patients Enrolled

Media Library

Nipocalimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04968912 — Phase 2
Sjogren's Syndrome Research Study Groups: Group 2: Nipocalimab Dose 1, Group 3: Nipocalimab Dose 2, Group 1: Placebo
Sjogren's Syndrome Clinical Trial 2023: Nipocalimab Highlights & Side Effects. Trial Name: NCT04968912 — Phase 2
Nipocalimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04968912 — Phase 2
Sjogren's Syndrome Patient Testimony for trial: Trial Name: NCT04968912 — Phase 2

Frequently Asked Questions

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

Would geriatric patients be appropriate for this research?

"This study's subjects must be between 18-75 years old."

Answered by AI

Are people currently able to sign up for this clinical trial?

"The clinical trial is recruiting participants and was first posted on 9/21/2021. The last edit to the listing was made on 10/25/2022 according to information found on clinicaltrials.gov"

Answered by AI

How many test subjects are participating in this experiment?

"That is correct. The clinicaltrials.gov website has the most recent information on this trial, which was updated on October 25th, 2022. This study originally posted September 21st, 2021 and is looking for 150 total participants from 25 different sites."

Answered by AI

What is the status of Nipocalimab in regards to government regulation?

"At Power, we gave Nipocalimab a score of 2 on our safety scale. This is because there is only some data supporting its safety, as this is a Phase 2 trial without any efficacy data."

Answered by AI

Who meets the screening criteria for this clinical trial?

"This study is recruiting 150 patients, between the ages of 18 and 75 who currently have sicca syndrome. It is required that participants also meet the following criteria: At least one abnormal laboratory marker of pSS-related inflammatory disease activity, and at least low activity in one or more specified European League Against Rheumatism Sjogren's syndrome Disease Activity Index (ESSDAI) domains, Meets classification criteria for primary Sjogren's syndrome (pSS) by the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) at the time"

Answered by AI

Are there precedents for Nipocalimab's use in medical research?

"There are a total of 5 clinical trials underway for the use of Nipocalimab. Of these, 2 are Phase 3 trials. Although many studies related to Nipocalimab originate from Canyon Country, California, there are 628 sites running trials worldwide."

Answered by AI

Is this particular clinical trial taking place in more than one state?

"This clinical trial is running at 25 locations, some of which are University of Iowa Hospitals and Clinics in Iowa City, Iowa, St. Jude Heritage Medical Group in Fullerton, California, and Arizona Arthritis & Rheumatology Research, PLLC in Mesa, Arizona ."

Answered by AI

What other similar studies preceded this one?

"Nipocalimab is being trialed in 33 countries and 103 cities as of right now. The very first study was completed in 2019 by Janssen Research & Development, LLC. That particular trial saw 111 patients through to the end of its Phase 2 & 3 stages. Since then, 18294 more trials have been carried out."

Answered by AI

Who else is applying?

What state do they live in?
Florida
California
Other
North Carolina
How old are they?
18 - 65
What site did they apply to?
Arizona Arthritis & Rheumatology Research, PLLC
PMG Research of Salisbury
Other
Inland Rheumatology Clinical Trials, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
1
0

Why did patients apply to this trial?

I have dry mouth. Condion has endured for years. Because I was recently diagnosed with Sjogrens syndrome.
PatientReceived 1 prior treatment
I have a dry mouth. This condition has endured for years. I have had Sjogrens for many years and would like to find relief.
PatientReceived 1 prior treatment
I have been in 2 trials before and hope to help myself and others with future medications/drugs to help my condition.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. University of Florida Health Jacksonville - Rheumatology: < 48 hours
  2. Inland Rheumatology Clinical Trials, Inc.: < 48 hours
Typically responds via
Phone Call
Email
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)
2021. "A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04968912.
~45 spots leftby May 2025
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