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Corticosteroid

Rilzabrutinib for IgG4-Related Disease

Phase 2

Waitlist Available

Research Sponsored by Principia Biopharma, a Sanofi Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a clinical diagnosis of IgG4-RD.

Be willing to taper off an equivalent prednisone dose of between 20-40 mg/day in 2 weeks.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 68 weeks

Awards & highlights

Study Summary

This trial is testing a new drug for IgG4-related disease, a condition where the body produces too much of the IgG4 protein.

Who is the study for?

This trial is for adults over 18 with IgG4-Related Disease who are willing to reduce their use of steroids like prednisone. It's not open to those with HIV, hepatitis B or C, TB, pregnant or nursing women, recent users of certain immune system affecting drugs unless their B cell levels are normal.Check my eligibility

What is being tested?

The study is testing the effectiveness and safety of a drug called Rilzabrutinib in combination with glucocorticoids (steroids), compared to using glucocorticoids alone in patients with active IgG4-related disease.See study design

What are the potential side effects?

Possible side effects may include reactions related to the immune system due to Rilzabrutinib or complications from reducing steroid use. The exact side effects will be monitored and recorded throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with IgG4-Related Disease.

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I am willing to gradually stop taking 20-40 mg/day of prednisone in 2 weeks.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 68 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 68 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 68 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of SAE, AE leading to discontinuation and possible glucocorticoid-related AE

Number of participants with Potentially clinically significant abnormalities (PCSAs) for clinical laboratory tests, vital signs and ECG

Proportion of participants who are without disease flare following the first dose of rilzabrutinib.

Secondary outcome measures

Immunoglobulin IgG4

Change from baseline over time in IgG4-RD damage, as recorded on the damage portion of the IgG4-RD RI

Level and change from baseline of each subclass of the serological markers

+4 more

Side effects data

From 2017 Phase 4 trial • 20 Patients • NCT02169219

25%

Severe flares

10%

Thyroid maligancy

Uterine malignancy

myocardial infarction

atrial fibrillation,

syncope

100%

80%

60%

40%

20%

Study treatment Arm

Glucocorticoids and Rituximab

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Rilzabrutinib + glucocorticoidsExperimental Treatment2 Interventions

Rilzabrutinib tablets, 400 mg twice daily from Week 0 to Week 12 plus glucocorticoids (20 to 40 mg/day prednisone equivalent tapered to 0 mg/day within 2 weeks on study)

Group II: GlucocorticoidsActive Control1 Intervention

Glucocorticoids (20 to 40 mg/day prednisone equivalent tapered to 0 mg/day within 12 weeks on study)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glucocorticoids

2011

Completed Phase 4

~1250

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Principia Biopharma, a Sanofi CompanyLead Sponsor

7 Previous Clinical Trials

556 Total Patients Enrolled

Massachusetts General HospitalOTHER

2,928 Previous Clinical Trials

13,198,328 Total Patients Enrolled

Media Library

Glucocorticoids (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04520451 — Phase 2

Immunoglobulin-related Disease Research Study Groups: Rilzabrutinib + glucocorticoids, Glucocorticoids

Immunoglobulin-related Disease Clinical Trial 2023: Glucocorticoids Highlights & Side Effects. Trial Name: NCT04520451 — Phase 2

Glucocorticoids (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04520451 — Phase 2

Frequently Asked Questions

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

At how many locations can participants access this medical trial?

"This medical trial is currently recruiting patients from a total of 5 different sites, located in Detroit, Stanford and Vancouver among others. It is advisable to select the most proximal clinic to reduce any travelling needs if you decide to join."

Answered by AI

Are volunteers currently being sought for this research endeavor?

"Affirmative. The info available on clinicaltrials.gov verifies that this investigation, first posted on August 22nd 2020, is presently signing up test subjects. Five sites are recruiting a total of 25 participants for the trial."

Answered by AI

What potential side effects could patients encounter with Glucocorticoids therapy?

"Glucocorticoids have been studied to some extent for safety, so they were awarded a score of 2. Unfortunately there has yet to be any data published that confirms their efficacy."

Answered by AI

What ailments is Glucocorticoids typically employed to treat?

"Glucocorticoids are frequently prescribed to manage multiple sclerosis. Additionally, they may be taken to mitigate ulcerative colitis, varicella-zoster virus acute retinal necrosis and various neurological conditions."

Answered by AI

Are there any prior research projects which employed Glucocorticoids?

"Currently, there are 389 studies researching Glucocorticoids. Of those active trials, 113 have reached the third phase of research. Although this treatment has its roots in Duarte, California; it is now being researched at 16804 different sites internationally."

Answered by AI

What is the current enrollment limit for this trial?

"The study mandates that 25 eligible patients be recruited, and these individuals can enroll at either Investigational Site Number 84018 in Detroit or Investigational Site Number 84019 in Stanford."

Answered by AI

Recent research and studies

Annals of the Rheumatic DiseasesJournal

Clinical Phenotypes of Igg4-related Disease: An Analysis of Two International Cross-sectional Cohorts

Wallace, Zachary S, Yuqing Zhang, Cory A Perugino, Ray Naden, Hyon K Choi, and John H Stone. 2019. “Clinical Phenotypes of Igg4-related Disease: An Analysis of Two International Cross-sectional Cohorts”. Annals of the Rheumatic Diseases. BMJ. doi:10.1136/annrheumdis-2018-214603.

clinicaltrials.govStudy

Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease Patients

2020. "Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04520451.