CLINICAL TRIALS PROFILE FOR RILZABRUTINIB

Clinical Trials for rilzabrutinib

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03762265 ↗	A Study of PRN1008 in Patients With Pemphigus	Active, not recruiting	Principia Biopharma, a Sanofi Company	Phase 3	This is a Phase 3 randomized, parallel-group, double-blind, placebo-controlled trial (Blinded Treatment Period) followed by an Open-Label Extension Period intended to evaluate the efficacy and safety of oral PRN1008 in moderate to severe pemphigus. After completing the Open-Label Extension Period, eligible patients may continue in a Long Term Extension Period of 48 weeks.
NCT03762265 ↗	A Study of PRN1008 in Patients With Pemphigus	Active, not recruiting	Principia Biopharma, Inc.	Phase 3	This is a Phase 3 randomized, parallel-group, double-blind, placebo-controlled trial (Blinded Treatment Period) followed by an Open-Label Extension Period intended to evaluate the efficacy and safety of oral PRN1008 in moderate to severe pemphigus. After completing the Open-Label Extension Period, eligible patients may continue in a Long Term Extension Period of 48 weeks.
NCT04520451 ↗	Open Label Two-Arm Study to Evaluate Rilzabrutinib (PRN1008) in IgG4-Related Disease Patients	Recruiting	Massachusetts General Hospital	Phase 2	PRN1008-017 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: PRN1008 with glucocorticoids and (2) Active Comparator: glucocorticoids only.
NCT04520451 ↗	Open Label Two-Arm Study to Evaluate Rilzabrutinib (PRN1008) in IgG4-Related Disease Patients	Recruiting	Principia Biopharma Inc.	Phase 2	PRN1008-017 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: PRN1008 with glucocorticoids and (2) Active Comparator: glucocorticoids only.
NCT04520451 ↗	Open Label Two-Arm Study to Evaluate Rilzabrutinib (PRN1008) in IgG4-Related Disease Patients	Recruiting	Principia Biopharma, a Sanofi Company	Phase 2	PRN1008-017 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: PRN1008 with glucocorticoids and (2) Active Comparator: glucocorticoids only.
NCT04562766 ↗	Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)	Recruiting	Principia Biopharma Inc.	Phase 3	This is a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of <30,000/μL (and no single platelet count >35,000/μL) on two counts at least 5 days apart in the 14 days before treatment begins. Patients will receive rilzabrutinib or placebo 400mg twice daily. For each patient, the study will last up to 60 weeks from the start of the Screening Period to the End of Study (EOS) visit. This includes Screening (up to 4 weeks) through a 12 to 24-week Blinded Treatment Period followed by a 28-week Open-Label Period. There is a 4-week post dose follow-up. Patients who respond per specified criteria at the end of the Open-Label Period will be able to enter a 12-month Long-Term Extension (LTE).

Clinical Trial Conditions for rilzabrutinib

Condition Name

Condition Name
Intervention	Trials
Asthma	1
Atopic Dermatitis	1
Autoimmune Haemolytic Anaemia	1
Chronic Spontaneous Urticaria	1

Condition MeSH

Condition MeSH
Intervention	Trials
Immunoglobulin G4-Related Disease	1
Hemolysis	1
Urticaria	1
Pemphigus	1

Clinical Trial Locations for rilzabrutinib

Trials by Country

Trials by Country
Location	Trials
United States	25
Australia	4
Spain	3
Poland	2
Argentina	2

Trials by US State

Trials by US State
Location	Trials
Florida	4
California	3
New York	2
Michigan	2
Massachusetts	2

Clinical Trial Progress for rilzabrutinib

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	5
Phase 1	1

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Not yet recruiting	3
Recruiting	3
Active, not recruiting	1

Clinical Trial Sponsors for rilzabrutinib

Sponsor Name

Sponsor Name
Sponsor	Trials
Sanofi	5
Principia Biopharma, a Sanofi Company	4
Principia Biopharma Inc.	2

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	12
Other	1