7 completed, 3 active not recruiting, 2 recruiting, 1 terminated. 6 Phase 1, 6 Phase 2, 2 Phase 3.
By phase and status
Follow tirabrutinib: new trials by email Literature Review of tirabrutinib trials Research Report on tirabrutinib
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
IGNITE: Study of Tirabrutinib vs Rituximab and Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) Tirabrutinib, Rituximab, Temozolomide - Relapsed/Refractory Primary Central Nervous System Lymphoma Phase 3 Recruiting Ono Pharmaceutical Co., Ltd. 132 2026-06-12 2026-10-20 A Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants Tirabrutinib - Primary Central Nervous System Lymphoma (PCNSL) Phase 1 Completed Ono Pharmaceutical Co., Ltd. 40 2025-10-01 2026-06-26 Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL ONO-4059, Rituximab, Methotrexate - Primary Central Nervous System Lymphoma Phase 1 Active not recruiting Ono Pharmaceutical Co., Ltd. 20 2024-05-17 2026-10-06 Tirabrutinib Maintenance Versus Placebo in Patients With Primary CNS Lymphoma in Complete Remission (JCOG2104) Tirabrutinib, Placebo - Primary Central Nervous System Lymphoma Phase 2 Recruiting Kyorin University 92 2023-10-06 2026-08-05 ONO-4059 Study in Patients With Steroid-resistant Pemphigus ONO-4059, ONO-4059 placebo - Pemphigus, Steroid-resistant Pemphigus Phase 3 Active not recruiting Ono Pharmaceutical Co., Ltd. 34 2022-08-15 2026-07-20 Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study) Tirabrutinib - Refractory Primary Central Nervous System Lymphoma, Primary CNS Lymphoma Phase 2 Active not recruiting Ono Pharmaceutical Co., Ltd. 119 2021-12-29 2026-03-30 Study to Evaluate the Efficacy, Safety, and Tolerability of Tirabrutinib in Participants With Antihistamine-Resistant Chronic Spontaneous Urticaria Tirabrutinib, Placebo - Chronic Spontaneous Urticaria Phase 2 Withdrawn Gilead Sciences 2021-07-01 2021-07-28 Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome Lanraplenib, Filgotinib, Tirabrutinib - Sjogren's Syndrome Phase 2 Completed Gilead Sciences 152 2017-05-01 2020-10-23 Safety and Efficacy of the Combination of Tirabrutinib and Entospletinib With and Without Obinutuzumab in Adults With Chronic Lymphocytic Leukemia (CLL) Tirabrutinib, Entospletinib, Obinutuzumab - Chronic Lymphocytic Leukemia Phase 2 Completed Gilead Sciences 36 2017-04-06 2021-12-21 Study to Evaluate the Safety and Efficacy of the Combination of Tirabrutinib and Idelalisib With and Without Obinutuzumab in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Tirabrutinib, Idelalisib, Obinutuzumab - Chronic Lymphocytic Leukemia Phase 2 Completed Gilead Sciences 35 2016-12-13 2022-01-21 Study to Evaluate Safety and Pharmacokinetics of GS-4059 (Tirabrutinib) in Healthy Volunteers and Participants With Rheumatoid Arthritis (RA) Tirabrutinib, Placebo - Rheumatoid Arthritis Phase 1 Completed Gilead Sciences 42 2016-01-26 2020-09-09 Study to Assess the Long-term Safety and Efficacy of Tirabrutinib in Adults With Relapsed/Refractory B-cell Malignancies Tirabrutinib - Relapsed/Refractory B-cell Malignancies Phase 1 Completed Gilead Sciences 29 2015-09-10 2022-03-24 Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies Tirabrutinib, Idelalisib, Entospletinib - B-cell Malignancies Phase 1 Terminated Gilead Sciences 203 2015-06-16 2025-06-17 Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL Tirabrutinib - Non Hodgkins Lymphoma, Chronic Lymphocytic Leukaemia Phase 1 Completed Gilead Sciences 90 2012-08-17 2021-03-16
Conditions studied Leukemia, Lymphocytic, Chronic, B-Cell (2) · Recurrence (2) · Arthritis, Rheumatoid (1) · Chronic Urticaria (1) · Leukemia, B-Cell (1) · Lymphoma, Non-Hodgkin (1) · Pemphigus (1) · Sjogren's Syndrome (1)
Sponsors Gilead Sciences (8) · Ono Pharmaceutical Co., Ltd. (5) · Kyorin University (1)
Countries United States (6) · France (4) · United Kingdom (4) · Japan (3) · Germany (2) · Spain (2) · Australia (1) · Brazil (1) · Czechia (1) · Italy (1) · Poland (1)
Top investigators Project Leader (4)
Results publications PMID 26542378 , PMID 27248633 , PMID 28178345 , PMID 28377400 , PMID 31827243 , PMID 35377447 , PMID 42317052 , PMID 42821736
NIH funding 2015 (4), 2016 (2), 2025 (1)