Glucocorticoids for IgG4-Related Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
IgG4-Related Disease+1 MoreGlucocorticoids - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

1 of 3

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

2 of 3
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
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT02169219) in the Glucocorticoids and Rituximab ARM group. Side effects include: Severe flares with 25%, Thyroid maligancy with 10%, myocardial infarction with 5%, Uterine malignancy with 5%, atrial fibrillation, with 5%.

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: Drug
Treatment
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.