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Monoclonal Antibodies
Nipocalimab for Myositis (SPIREA Trial)
Phase 2
Recruiting
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
Participant meets the diagnostic criteria of probable or definite idiopathic inflammatory myopathies (IIM) based on 2017 The European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult IIM at least 6 weeks prior to first administration of the study intervention
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 44 through week 52
Awards & highlights
SPIREA Trial Summary
This trial is testing a new drug to see if it can help people with a muscle disease called idiopathic inflammatory myopathies.
Who is the study for?
This trial is for adults with active idiopathic inflammatory myopathies (IIM) who have certain antibodies indicating specific types of IIM. They must meet the EULAR/ACR criteria for IIM and have stable skin treatment doses for at least 4 weeks before starting the study. People with juvenile myositis, cancer-associated myositis, frequent oral steroid use due to other diseases, or recent severe heart issues cannot join.Check my eligibility
What is being tested?
The trial is testing Nipocalimab's effectiveness compared to a placebo in treating IIM. Participants will also receive glucocorticoids as part of their therapy. The goal is to see if Nipocalimab can help manage symptoms better than a non-active treatment.See study design
What are the potential side effects?
Possible side effects of Nipocalimab may include reactions at the injection site, increased risk of infections due to immune system suppression, allergic responses, and potential impacts on blood cell counts leading to anemia or bleeding problems.
SPIREA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of muscle inflammation disease at least 6 weeks ago.
SPIREA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 44 through week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 44 through week 52
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 who Achieve at Least Minimal Improvement (Greater Than or Equal to [>=] 20) in IMACS TIS and on Less Than or Equal to (<=) 5 Milligrams per day (mg/day) of Oral Prednisone (or Equivalent) From Week 44 Through Week 52
Secondary outcome measures
Change From Baseline in Extramuscular Global Assessment (Myositis Disease Activity Assessment Tool [MDAAT]) at Weeks 24 and 52
Change From Baseline in Functional Disability Using the Health Assessment Questionnaire-disability Index (HAQ-DI)
Change From Baseline in MMT-8 at Week 24
+23 moreSide effects data
From 2017 Phase 4 trial • 20 Patients • NCT0216921925%
Severe flares
10%
Thyroid maligancy
5%
Uterine malignancy
5%
myocardial infarction
5%
atrial fibrillation,
5%
syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Glucocorticoids and Rituximab
SPIREA Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NipocalimabExperimental Treatment2 Interventions
Participants will receive Nipocalimab at Week 0 (Baseline) and then every 2 weeks (Q2W) up to Week 50 during double-blind period. Participants on glucocorticoids (GC) at baseline will receive a stable dose of oral GC (prednisone or equivalent) from 4 weeks prior to the first administration of study intervention to Week 0. No changes in GC doses are allowed between Week 0 and Week 24. From Week 24 to Week 44, GC doses will be tapered. No changes to GC doses will be allowed from Week 44 to Week 52. Eligible participants will enter long-term extension (LTE) period and continue receiving Nipocalimab starting from Week 52 up to Week 98 and will be followed up to Week 106.
Group II: PlaceboPlacebo Group2 Interventions
Participants will receive Nipocalimab matching placebo at Week 0 (Baseline) and then Q2W up to Week 50 during double-blind period. Participants on GC at baseline will receive a stable dose of oral GC (prednisone or equivalent) from 4 weeks prior to the first administration of study intervention to Week 0. No changes in GC doses are allowed between Week 0 and Week 24. From Week 24 to Week 44, GC doses will be tapered. No changes to GC doses will be allowed from Week 44 to Week 52. Eligible participants will enter LTE period and continue receiving Nipocalimab matching placebo Q2W starting from Week 52 up to Week 98 and will be followed up to Week 106.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nipocalimab
2022
Completed Phase 2
~420
Glucocorticoids
2011
Completed Phase 4
~1250
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,108 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,705 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tested positive for specific antibodies related to my muscle condition.I've been on a stable dose of certain skin treatment creams for over 4 weeks.I have been diagnosed with a type of muscle inflammation disease at least 6 weeks ago.I have had to take oral steroids 3 or more times in the last year for my asthma or COPD.I had a heart attack, unstable heart disease, or stroke in the last 3 months.I've been on a stable dose of certain skin medication for at least 4 weeks.I was diagnosed with juvenile myositis and am now 18 or older.I was diagnosed with cancer and myositis within 3 years of each other, excluding skin cancer and cervical carcinoma in situ.I have a history of immune system problems not caused by my current treatment.I have been diagnosed with a type of muscle inflammation disease for at least 6 weeks.I tested positive for specific antibodies related to my muscle condition.
Research Study Groups:
This trial has the following groups:- Group 1: Nipocalimab
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people have signed up to participate in this experiment?
"Janssen Research & Development, LLC sponsors this study that needs 200 eligible participants. The trial will take place at University of California Los Angeles located in Los Angeles, California and The Brigham and Women's Hospital, Inc. situated in Boston, Massachusetts."
Answered by AI
Would Nipocalimab be harmful if used outside of a hospital setting?
"Nipocalimab's score of 2 on our internal 1-3 scale reflects the fact that, while there is some evidence backing its safety, there is no data yet supporting efficacy."
Answered by AI
In how many different medical locations is this research project being conducted today?
"There are a total of 19 sites for this study, which include University of California Los Angeles in Los Angeles, California, The Brigham and Women's Hospital, Inc. in Boston, Massachusetts, and University of Kansas Medical Center in Kansas City, Kansas among others."
Answered by AI
Are there still opportunities for patients to enroll in this research study?
"Yes, clinicaltrials.gov has the latest information on this trial recruiting patients. The listing says that the trial was posted on 7/5/2022 and updated last on 10/25/2022. They are looking for 200 more people to participate across 16 locations."
Answered by AI
Why was this clinical trial created?
"The primary outcome of this trial is the percentage of participants who achieve at least minimal improvement in International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) over a 52-week period. Secondary outcomes include change from baseline in functional disability using the Health Assessment Questionnaire-disability Index (HAQ-DI), change from baseline in physician global assessment (PhGA) at weeks 24 and 52, and change from baseline in serum muscle enzyme levels at weeks 24 and 52."
Answered by AI
Who else is applying?
What state do they live in?
California
District of Columbia
Pennsylvania
Other
How old are they?
18 - 65
65+
What site did they apply to?
University of California Irvine Medical Center
University of California Los Angeles
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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