Clinical Trials ONO is carrying out clinical trials in oncology and neurology in the United States.* Breadcrumb Our Pipeline Clinical Trials 5 Projects Underway 6 Diseases Researching U.S. Clinical Trials Study of Tirabrutinib in Patients With Primary Central Nervous System Lymphoma: The PROSPECT Trial Oncology Disease / Condition: Primary central nervous system lymphoma (PCNSL) Requirements: 18+ | All Recruiting Study of Tirabrutinib in Patients With Primary Central Nervous System Lymphoma: The PROSPECT Trial Posted on 07/01/2021 Recruiting Go to ClinicalTrials.gov Copy Link to Clipboard Medical area of focus Oncology Disease / Condition: Primary central nervous system lymphoma (PCNSL) Study Summary Current treatment options for primary central nervous system lymphoma (PCNSL) are limited, and there are currently no medications approved specifically for the treatment of PCNSL in the United States. The PROSPECT Study, sponsored by ONO, is evaluating an investigational therapeutic option for the treatment of both newly diagnosed and relapsed/refractory PCNSL. The investigational product, tirabrutinib, is approved and is currently marketed in Japan for relapsed/refractory PCNSL. Tirabrutinib is currently not FDA-approved for any use in the United States. The PROSPECT study is enrolling approximately 112 participants at study sites across the U.S. Find out more about the PROSPECT study. Study Design Overview This study has two parts. Part A evaluates tirabrutinib monotherapy in patients with relapsed or refractory PCNSL with at least one prior high-dose methotrexate (HD-MTX) based therapy for PCNSL. Part B evaluates tirabrutinib in combination with one of two different HD-MTX-based regimens (methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first-line therapy in patients with newly diagnosed, treatment-naïve PCNSL. For full study details, visit Clinicaltrials.gov *This molecule is not FDA approved for any use. Close tab Study of ONO-4685 in Patients With Relapsed or Refractory T-Cell Lymphoma Oncology Disease / Condition: Relapsed/refractory t-cell lymphoma Requirements: 18+ | All Recruiting Study of ONO-4685 in Patients With Relapsed or Refractory T-Cell Lymphoma Posted on 10/15/2021 Recruiting Go to ClinicalTrials.gov Copy Link to Clipboard Medical area of focus Oncology Disease / Condition: Relapsed/refractory t-cell lymphoma Study Summary This Phase 1 study investigates the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T-cell Lymphoma. Study Design Overview This study evaluates ONO-4685 in people with peripheral T-cell lymphomas or cutaneous T-cell lymphomas who have received at least two prior systemic therapies. The trial is enrolling approximately 217 patients across 11 locations throughout the United States. For full study details, visit Clinicaltrials.gov *This molecule is not approved by any regulatory authority for any use. Close tab Study of ONO-7018 in Patients With R/R Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia Oncology Disease / Condition: Non-Hodgkin lymphoma Chronic lymphocytic leukemia Requirements: 18+ | All Recruiting Study of ONO-7018 in Patients With R/R Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia Posted on 08/25/2022 Recruiting Go to ClinicalTrials.gov Copy Link to Clipboard Medical area of focus Oncology Disease / Condition: Non-Hodgkin lymphoma Chronic lymphocytic leukemia Study Summary This is a Phase 1, open-label, multi-center study to evaluate ONO-7018 in people with patients with relapsed or refractory non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL). Study Design Overview The trial is in two phases. Part 1: Dose Escalation Phase, in which eligible patients will be assigned to a dose level cohort according to a traditional 3+3 dose escalation design. Part 2: Dose Expansion Phase, in which eligible patients will be assigned to the recommended dose level(s) selected from Part 1. The study will recruit approximately 54 participants at 10 trial sites across the Unites States. For full study details, visit Clinicaltrials.gov *This molecule is not approved by any regulatory authority for any use. Close tab A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy Neurology Disease / Condition: Multiple system atrophy (MSA) Requirements: 30-80 years | All Recruiting A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy Posted on 06/28/2023 Recruiting Go to ClinicalTrials.gov Copy Link to Clipboard Medical area of focus Neurology Disease / Condition: Multiple system atrophy (MSA) Study Summary The purpose of the study is to evaluate three doses of ONO-2808 compared to placebo in MSA patients, including: 1) safety and tolerability, 2) pharmacokinetics, and 3) changes in clinical outcome assessments and biomarkers considered to be related to the pharmacodynamics and potential efficacy of ONO-2808. Study Design Overview The study will include oral administration of ONO-2808 at low, middle, or high doses once a day for 24 weeks or oral administration of placebo once a daily for 24 weeks. It aims to recruit approximately 80 participants. For full study details, visit Clinicaltrials.gov *This molecule is not approved by any regulatory authority for any use. Close tab A Phase 1 Study of ONO-2020 in Healthy Participants Neurology Disease / Condition: Neurodegenerative disease Requirements: 18+ | All Recruiting A Phase 1 Study of ONO-2020 in Healthy Participants Posted on 08/19/2022 Recruiting Go to ClinicalTrials.gov Copy Link to Clipboard Medical area of focus Neurology Disease / Condition: Neurodegenerative disease Study Summary The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ONO-2020 in healthy adult participants. Study Design Overview The study consists of five parts (Parts A-E) to study single or multiple doses of ONO-2020 in healthy participants, including elderly and Japanese participants, as well as the food effect on the pharmacokinetics of ONO-2020. These data will support the clinical development program and help inform dose selection in future studies. The trial is currently recruiting approximately 138 participants. For full study details, visit Clinicaltrials.gov *This molecule is not approved by any regulatory authority for any use. Close tab Expanded Access to Investigational Products Read our EAP policy. Our Science Learn more about Our Science. *None of the listed molecules are FDA approved for any use.
