9 completed, 5 recruiting, 3 active not recruiting, 1 not yet recruiting. 8 Phase 2, 7 Phase 3, 4 Phase 1.
By phase and status
Follow rilzabrutinib: new trials by email Literature Review of rilzabrutinib trials Research Report on rilzabrutinib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
rilzabrutinib - Renal Impairment, Healthy Volunteers | Phase 1 | Not yet recruiting | Sanofi | 16 | 2026-10-09 | 2026-10-01 |
An Open-label DDI Study to Investigate the Effect of Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 Inhibition
Rilzabrutinib, Rosuvastatin, Digoxin - Healthy Volunteer | Phase 1 | Active not recruiting | Sanofi | 14 | 2026-10-01 | 2026-10-21 |
Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
rilzabrutinib - Immune Thrombocytopenia | Phase 3 | Recruiting | Sanofi | 60 | 2025-10-24 | 2026-06-22 |
Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan
rilzabrutinib - Immune Thrombocytopenia | Phase 3 | Active not recruiting | Sanofi | 4 | 2025-10-15 | 2025-11-06 |
A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease
Rilzabrutinib, Placebo, Glucocorticoid - Immunoglobulin G4 Related Disease | Phase 3 | Recruiting | Sanofi | 124 | 2025-09-26 | 2026-10-20 |
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
rilzabrutinib, placebo - Autoimmune Haemolytic Anaemia | Phase 3 | Recruiting | Sanofi | 90 | 2025-08-18 | 2026-10-20 |
The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease
Rilzabrutinib, Placebo - Sickle Cell Disease | Phase 3 | Recruiting | Sanofi | 192 | 2025-08-12 | 2026-10-15 |
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
frexalimab, brivekimig, rilzabrutinib - Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion | Phase 2 | Recruiting | Sanofi | 84 | 2024-12-19 | 2026-10-19 |
Proof of Concept Study of Rilzabrutinib in Adult Participants With Moderate-to-severe Asthma
Rilzabrutinib, placebo - Asthma | Phase 2 | Completed | Sanofi | 196 | 2021-12-12 | 2024-03-07 |
Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)
rilzabrutinib - Warm Autoimmune Hemolytic Anemia (wAIHA) | Phase 2 | Active not recruiting | Sanofi | 22 | 2021-12-07 | 2026-06-05 |
Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine
rilzabrutinib, placebo - Chronic Spontaneous Urticaria | Phase 2 | Completed | Sanofi | 160 | 2021-11-24 | 2026-08-06 |
Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis
Placebo, Rilzabrutinib - Atopic Dermatitis | Phase 2 | Completed | Sanofi | 124 | 2021-09-09 | 2026-07-13 |
Pharmacokinetics (PK) of Rilzabrutinib (PRN1008) in Healthy Japanese and Caucasian Subjects
Rilzabrutinib - Healthy Volunteers | Phase 1 | Completed | Principia Biopharma, a Sanofi Company | 23 | 2021-01-04 | 2024-06-05 |
Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)
Rilzabrutinib, Placebo - Immune Thrombocytopenia | Phase 3 | Completed | Principia Biopharma, a Sanofi Company | 232 | 2020-12-14 | 2026-10-07 |
A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)
Rilzabrutinib - Hepatic Function Abnormal, Healthy Volunteers | Phase 1 | Completed | Principia Biopharma, a Sanofi Company | 29 | 2020-11-02 | 2024-06-05 |
Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease Participants
rilzabrutinib, Glucocorticoids - Immunoglobulin G4 Related Disease | Phase 2 | Completed | Principia Biopharma, a Sanofi Company | 27 | 2020-08-22 | 2025-10-14 |
A Study of PRN1008 in Patients With Pemphigus
Rilzabrutinib, Placebo - Pemphigus | Phase 3 | Terminated | Principia Biopharma, a Sanofi Company | 131 | 2019-01-08 | 2023-08-02 |
A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)
Rilzabrutinib - Immune Thrombocytopenia | Phase 2 | Completed | Principia Biopharma, a Sanofi Company | 86 | 2018-03-22 | 2026-02-23 |
A Study of PRN1008 in Adult Patients With Pemphigus Vulgaris
PRN1008 - Pemphigus Vulgaris | Phase 2 | Completed | Principia Biopharma, a Sanofi Company | 42 | 2016-01-22 | 2023-02-13 |
Conditions studied
Purpura, Thrombocytopenic, Idiopathic (4) · Immunoglobulin G4-Related Disease (2) · Pemphigus (2) · Anemia, Hemolytic, Autoimmune (1) · Anemia, Sickle Cell (1) · Asthma (1) · Chronic Urticaria (1) · Dermatitis, Atopic (1) · Glomerulosclerosis, Focal Segmental (1) · Liver Diseases (1) · Nephrosis, Lipoid (1) · Renal Insufficiency (1)
Sponsors
Sanofi (12) · Principia Biopharma, a Sanofi Company (7)
Countries
United States (13) · Germany (11) · Spain (11) · Canada (10) · Italy (10) · Poland (9) · France (8) · Netherlands (8) · United Kingdom (8) · Argentina (7) · Chile (6) · Greece (6) · Hungary (6) · Israel (6) · Australia (5)
Top investigators
Olga Bandman, MD (1)
Results publications
PMID 39899371, PMID 34922648, PMID 35417637, PMID 37869360, PMID 38386978, PMID 39844469, PMID 40090011, PMID 40266575, PMID 41936356, PMID 42106923, PMID 42753771, PMID 42822477
NIH funding
2023 (3), 2015 (1), 2018 (1), 2025 (1)