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.
Eligible Conditions
- IgG4-Related Disease
- Immunoglobulin G4-related Disease
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 9 Secondary · Reporting Duration: Week 4 to Week 12
At Week 12
Immunoglobulin IgG4
At Week 52
Level and change from baseline of each subclass of the serological markers
Proportion of participants who are without disease flare for at least 24 consecutive weeks following the first dose of rilzabrutinib.
Proportion of participants with reduction from baseline IgG4-RD RI activity score ≥2 points at Week 12
Proportion of patients with an IgG4-RD RI activity score = 0 at Week 12
Week 52
Immunoglobulin IgG4
Change from baseline over time in IgG4-RD damage, as recorded on the damage portion of the IgG4-RD RI
Until Week 52
Proportion of participants with no disease flares between Week 4 and Week 12, and between Week 12 and Week 52 (or the end of the treatment extension period) among the participants who have treatment extension
Up to 68 weeks
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
Week 56
IgG4-RD Responder Index
Serum IgG4 concentrations
Week 12
The proportion of patients who achieve complete remission at Week 12 with no glucocorticoid use at Week 4 for the Experimental Arm and Week 12 for the Active Comparator Arm.
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Glucocorticoids and Rituximab
25%Severe flares
10%Thyroid maligancy
5%myocardial infarction
5%Uterine malignancy
5%atrial fibrillation,
5%syncope
Trial Design
3 Treatment Groups
Glucocorticoids
1 of 3
Rilzabrutinib + glucocorticoids
1 of 3
PRN1008 plus glucocorticoids
1 of 3
Active Control
Experimental Treatment
25 Total Participants · 3 Treatment Groups
Primary Treatment: Glucocorticoids · No Placebo Group · Phase 2
Rilzabrutinib + glucocorticoidsExperimental Group · 2 Interventions: rilzabrutinib, Glucocorticoids · Intervention Types: Drug, Drug
PRN1008 plus glucocorticoidsExperimental Group · 2 Interventions: rilzabrutinib, Glucocorticoids · Intervention Types: Drug, Drug
Glucocorticoids
Drug
ActiveComparator Group · 1 Intervention: Glucocorticoids · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 4 to week 12
Who is running the clinical trial?
Massachusetts General HospitalOTHER
2,698 Previous Clinical Trials
30,843,111 Total Patients Enrolled
Principia Biopharma, a Sanofi CompanyLead Sponsor
7 Previous Clinical Trials
585 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are male or female, and you are aged at least 18 years.
You are willing to taper off an equivalent prednisone dose of between 20-40 mg/day in 2 weeks.
References
- 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.
- 2020. "Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04520451.
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
Conditions
Cancer Related
Treatments