A Study of GDC-0853 in Patients With Resistant B-Cell Lymphoma or Chronic Lymphocytic Leukemia.
Active, not recruiting
Genentech, Inc.
Phase 1
This open-label, Phase I study will evaluate the safety, tolerability, and pharmacokinetics
of increasing doses of GDC-0853 in patients with relapsed or refractory B-cell non-Hodgkin's
lymphoma or chronic lymphocytic leukemia. In a dose-expansion part, GDC-0853 will be assessed
in subsets of patients.
A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study
Terminated
Genentech, Inc.
Phase 2
This is a Phase II, multicenter, open-label extension (OLE) study to evaluate the long-term
safety and efficacy of fenebrutinib in participants with Chronic Spontaneous Urticaria (CSU)
who have completed the treatment period in a fenebrutinib CSU parent study. Participants may
enroll in this OLE study at any time after completing the treatment period of the parent
study. Participants will receive open-label fenebrutinib at a dose of 200 milligram (mg)
orally twice a day. Treatment may continue until the end of the study.
A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Participants With Primary Progressive Multiple Sclerosis
Recruiting
Hoffmann-La Roche
Phase 3
A study to evaluate the efficacy and safety of fenebrutinib on disability progression in
adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible
participants will be randomized 1:1 to either daily oral fenebrutinib (or placebo) or
intravenous (IV) ocrelizumab (or placebo) in a blinded fashion through an interactive voice
or web-based response system (IxRS). Approximately 946 participants will be enrolled and will
be recruited globally. Participants who discontinue study medication early or discontinue
from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a
positive benefit-risk result in the Primary Analysis of the study.
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