fenebrutinib: Clinical Trials

10 completed, 4 active not recruiting, 2 terminated, 1 recruiting. 8 Phase 2, 6 Phase 1, 3 Phase 3.

By phase and status

Phase	Trials	Status
Phase 2	8	Completed 4, Terminated 2, Active not recruiting 1, Recruiting 1
Phase 1	6	Completed 6
Phase 3	3	Active not recruiting 3

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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
A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS) Fenebrutinib - Relapsing Multiple Sclerosis	Phase 2	Recruiting	Hoffmann-La Roche	12	2025-10-06	2026-10-13
A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS) Fenebrutinib, Placebo - Relapsing Multiple Sclerosis	Phase 2	Active not recruiting	Hoffmann-La Roche	109	2022-03-01	2026-09-25
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) Fenebrutinib, Teriflunomide, Placebo - Relapsing Multiple Sclerosis	Phase 3	Active not recruiting	Hoffmann-La Roche	751	2021-03-24	2026-09-17
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) Fenebrutinib, Teriflunomide, Placebo - Relapsing Multiple Sclerosis	Phase 3	Active not recruiting	Hoffmann-La Roche	746	2021-03-17	2026-09-21
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis Fenebrutinib, Ocrelizumab, Placebo matched to ocrelizumab - Multiple Sclerosis, Primary Progressive	Phase 3	Active not recruiting	Hoffmann-La Roche	985	2020-10-26	2026-09-17
A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study GDC-0853 - Urticaria	Phase 2	Terminated	Genentech, Inc.	31	2018-09-27	2020-09-25
Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers Fenebrutinib - Healthy Participants	Phase 1	Completed	Hoffmann-La Roche	8	2018-07-27	2018-12-06
An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus GDC-0853 - Lupus Erythematosus, Systemic	Phase 2	Terminated	Genentech, Inc.	160	2018-01-09	2020-12-19
A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU). GDC-0853, Placebo - Urticaria	Phase 2	Completed	Genentech, Inc.	134	2017-05-26	2020-09-29
A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants GDC-0853, Rabeprazole - Healthy Volunteers	Phase 1	Completed	Genentech, Inc.	63	2017-04-18	2019-09-11
A Drug-Drug Interaction Study Between GDC-0853 and Midazolam, Itraconazole, Rosuvastatin, and Simvastatin Midazolam, GDC-0853, Midazolam and GDC-0853 - Healthy Participants	Phase 1	Completed	Genentech, Inc.	63	2017-04-18	2019-09-24
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian Participants GDC-0853, Placebo - Healthy Volunteer	Phase 1	Completed	Hoffmann-La Roche	32	2017-01-24	2019-08-07
A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus GDC-0853, Placebo - Systemic Lupus Erythematosus	Phase 2	Completed	Genentech, Inc.	260	2017-01-19	2024-05-08
A Study to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Rheumatoid Arthritis Enrolled in Study GA29350 GDC-0853 - Rheumatoid Arthritis	Phase 2	Completed	Genentech, Inc.	496	2016-11-30	2020-08-03
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) GDC-0853, Adalimumab, Folic Acid - Rheumatoid Arthritis	Phase 2	Completed	Genentech, Inc.	578	2016-09-09	2020-06-12
Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects Folic Acid, GDC-0853, Methotrexate - Healthy Volunteer	Phase 1	Completed	Genentech, Inc.	50	2015-09-03	2020-03-02
A Study of GDC-0853 in Patients With Resistant B-Cell Lymphoma or Chronic Lymphocytic Leukemia. GDC-0853 - Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma	Phase 1	Completed	Genentech, Inc.	24	2013-12-16	2022-06-21

Conditions studied

Arthritis, Rheumatoid (2)  ·  Lupus Erythematosus, Systemic (2)  ·  Urticaria (2)  ·  Bronchiolitis Obliterans Syndrome (1)  ·  Leukemia, Lymphoid (1)  ·  Lymphoma, Large B-Cell, Diffuse (1)  ·  Multiple Sclerosis, Chronic Progressive (1)

Sponsors

Genentech, Inc. (10)  ·  Hoffmann-La Roche (7)

Countries

United States (14)  ·  Mexico (8)  ·  Argentina (7)  ·  Brazil (7)  ·  Bulgaria (6)  ·  Poland (6)  ·  United Kingdom (6)  ·  Colombia (5)  ·  Russia (5)  ·  Spain (5)  ·  Ukraine (5)  ·  Germany (4)  ·  Serbia (4)  ·  South Korea (4)  ·  Canada (3)

Results publications

PMID 34042314, PMID 40683275

NIH funding

2016 (4), 2017 (2), 2019 (2), 2015 (1), 2018 (1)