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

P

Principia Biopharma

Status and phase

Completed
Phase 2

Conditions

Immunoglobulin G4 Related Disease

Treatments

Drug: Glucocorticoids
Drug: rilzabrutinib

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04520451
U1111-1260-3972 (Registry Identifier)
2022-002959-18 (EudraCT Number)
PRN1008-017 (Other Identifier)
ACT17125

Details and patient eligibility

About

This is a Phase 2a, multi-center, open-label, two-arm study of approximately 25 patients with active IgG4-related disease (IgG4-RD). The two arms include (1) Experimental: rilzabrutinib with glucocorticoids and (2) Active Comparator: glucocorticoids only.

Full description

4 weeks of screening, 12 weeks of main treatment, 12 weeks of cross-over (for GC-only group), 40 weeks of extension treatment and 4-week follow-up.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Be male or female with age ≥18 years.
  • 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.

Key Exclusion Criteria:

  • Currently or within 6 months of screening taking rituximab, other B-cell depleting agents, or alkylating agents unless B cell concentrations have been demonstrated by flow cytometry to return to normal values (defined as 5 cells per cubic mm).
  • History of solid organ transplant
  • Positive at Screening for HIV, hepatitis B, hepatitis C, or TB
  • Female patients who are pregnant or nursing.
  • NOTE: Other Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

27 participants in 2 patient groups

Rilzabrutinib + glucocorticoids
Experimental group
Description:
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)
Treatment:
Drug: rilzabrutinib
Drug: Glucocorticoids
Glucocorticoids
Active Comparator group
Description:
Glucocorticoids (20 to 40 mg/day prednisone equivalent tapered to 0 mg/day within 12 weeks on study)
Treatment:
Drug: Glucocorticoids

Trial contacts and locations

9

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Central trial contact

Trial Transparency email recommended (Toll free number for US & Canada)

Data sourced from clinicaltrials.gov

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