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ClinicalTrials.gov public records Last synced Sep 17, 2026, 8:45 PM EDT

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Showing 1–14 of 14 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Filters: Intervention: Rilzabrutinib Clear all
Active, not recruiting Phase 2 Interventional

Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)

NCT05002777
View directory record Official record
Conditions
Warm Autoimmune Hemolytic Anemia (wAIHA)
Interventions
rilzabrutinib
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2029
U.S. locations
11
States / cities
Cerritos, California • Glendale, California • Long Beach, California + 7 more
Source: ClinicalTrials.gov public record
Updated Jun 4, 2026 · Synced Sep 17, 2026, 8:45 PM EDT
Completed Phase 2 Interventional Results available

A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)

NCT03395210
View directory record Official record
Conditions
Immune Thrombocytopenia
Interventions
Rilzabrutinib
Drug
Lead sponsor
Principia Biopharma, a Sanofi Company
Industry
Eligibility
18 Years to 80 Years
Enrollment
86 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2025
U.S. locations
8
States / cities
Peoria, Illinois • Bethesda, Maryland • Boston, Massachusetts + 4 more
Source: ClinicalTrials.gov public record
Updated Feb 22, 2026 · Synced Sep 17, 2026, 8:45 PM EDT
Active, not recruiting Phase 3 Interventional Results available

Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)

NCT04562766
View directory record Official record
Conditions
Immune Thrombocytopenia
Interventions
Rilzabrutinib, Placebo
Drug
Lead sponsor
Principia Biopharma, a Sanofi Company
Industry
Eligibility
10 Years and older
Enrollment
232 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
17
States / cities
Los Angeles, California • San Francisco, California • Torrance, California + 13 more
Source: ClinicalTrials.gov public record
Updated Feb 22, 2026 · Synced Sep 17, 2026, 8:45 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

NCT06342700
View directory record Official record
Conditions
Autoimmune Disorder, Healthy Volunteers
Interventions
Rilzabrutinib crystalline form, Rilzabrutinib amorphous form
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 55 Years
Enrollment
28 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024
U.S. locations
1
States / cities
Saint Paul, Minnesota
Source: ClinicalTrials.gov public record
Updated Sep 2, 2025 · Synced Sep 17, 2026, 8:45 PM EDT
Terminated Phase 3 Interventional Results available

A Study of PRN1008 in Patients With Pemphigus

NCT03762265
View directory record Official record
Conditions
Pemphigus
Interventions
Rilzabrutinib, Placebo
Drug
Lead sponsor
Principia Biopharma, a Sanofi Company
Industry
Eligibility
18 Years to 80 Years
Enrollment
131 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
14
States / cities
Boca Raton, Florida • Coral Gables, Florida • Atlanta, Georgia + 9 more
Source: ClinicalTrials.gov public record
Updated Aug 1, 2023 · Synced Sep 17, 2026, 8:45 PM EDT
Completed Phase 2 Interventional Results available

Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis

NCT05018806
View directory record Official record
Conditions
Atopic Dermatitis
Interventions
Placebo, Rilzabrutinib
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
124 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
9
States / cities
Northridge, California • Colorado Springs, Colorado • Miami, Florida + 5 more
Source: ClinicalTrials.gov public record
Updated Jul 12, 2026 · Synced Sep 17, 2026, 8:45 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)

NCT06444204
View directory record Official record
Conditions
Hepatic Function Abnormal, Healthy Volunteers
Interventions
Rilzabrutinib
Drug
Lead sponsor
Principia Biopharma, a Sanofi Company
Industry
Eligibility
18 Years to 75 Years
Enrollment
29 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2021
U.S. locations
2
States / cities
Miami, Florida • Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Jun 4, 2024 · Synced Sep 17, 2026, 8:45 PM EDT
Recruiting Phase 3 Interventional

The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease

NCT06975865
View directory record Official record
Conditions
Sickle Cell Disease
Interventions
Rilzabrutinib, Placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
10 Years to 65 Years
Enrollment
192 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
16
States / cities
Birmingham, Alabama • Phoenix, Arizona • Fresno, California + 13 more
Source: ClinicalTrials.gov public record
Updated Jul 28, 2026 · Synced Sep 17, 2026, 8:45 PM EDT
Recruiting Phase 2 Interventional

A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease

NCT06500702
View directory record Official record
Conditions
Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
Interventions
frexalimab, brivekimig, rilzabrutinib, placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
16 Years to 75 Years
Enrollment
84 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
16
States / cities
Birmingham, Alabama • Orange, California • San Francisco, California + 13 more
Source: ClinicalTrials.gov public record
Updated Jul 19, 2026 · Synced Sep 17, 2026, 8:45 PM EDT
Completed Phase 2 Interventional

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

NCT04520451
View directory record Official record
Conditions
Immunoglobulin G4 Related Disease
Interventions
rilzabrutinib, Glucocorticoids
Drug
Lead sponsor
Principia Biopharma, a Sanofi Company
Industry
Eligibility
18 Years and older
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
5
States / cities
Stanford, California • Boston, Massachusetts • Detroit, Michigan + 2 more
Source: ClinicalTrials.gov public record
Updated Oct 13, 2025 · Synced Sep 17, 2026, 8:45 PM EDT
Recruiting Phase 3 Interventional

Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment

NCT07007962
View directory record Official record
Conditions
Immune Thrombocytopenia
Interventions
rilzabrutinib
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
12
States / cities
Clovis, California • Los Angeles, California • New Orleans, Louisiana + 8 more
Source: ClinicalTrials.gov public record
Updated Jun 21, 2026 · Synced Sep 17, 2026, 8:45 PM EDT
Recruiting Phase 3 Interventional

A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Participants 18 Years of Age and Older With Warm Autoimmune Hemolytic Anemia

NCT07086976
View directory record Official record
Conditions
Autoimmune Haemolytic Anaemia
Interventions
rilzabrutinib, placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
23
States / cities
Phoenix, Arizona • Tucson, Arizona • Duarte, California + 20 more
Source: ClinicalTrials.gov public record
Updated Aug 20, 2026 · Synced Sep 17, 2026, 8:45 PM EDT
Recruiting Phase 3 Interventional

A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease

NCT07190196
View directory record Official record
Conditions
Immunoglobulin G4 Related Disease
Interventions
Rilzabrutinib, Placebo, Glucocorticoid
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
124 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
17
States / cities
Fontana, California • San Jose, California • Tustin, California + 14 more
Source: ClinicalTrials.gov public record
Updated Jul 27, 2026 · Synced Sep 17, 2026, 8:45 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Pharmacokinetics (PK) of Rilzabrutinib (PRN1008) in Healthy Japanese and Caucasian Subjects

NCT06444191
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Rilzabrutinib
Drug
Lead sponsor
Principia Biopharma, a Sanofi Company
Industry
Eligibility
18 Years to 75 Years
Enrollment
23 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021
U.S. locations
1
States / cities
Glendale, California
Source: ClinicalTrials.gov public record
Updated Jun 4, 2024 · Synced Sep 17, 2026, 8:45 PM EDT