RECRUITING

A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary purpose of the study is to evaluate the safety and tolerability of a single-ascending intravenous (IV) dose (Part 1), a single-ascending subcutaneous (SC) dose (Part 2), and multiple ascending SC doses (Part 3) of RO7121932 in participants with multiple sclerosis (MS).

Official Title

A Multiple-center, Non-randomized, Open-label, Adaptive, Single-ascending Dose (Part 1 and Part 2) and Multiple-ascending Dose (Part 3) Parallel, Phase IB Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of RO7121932 Following Intravenous (Parts 1) and Subcutaneous Administration (Parts 2 and 3) in Participants With Multiple Sclerosis

Quick Facts

Study Start:2021-08-11

Study Completion:2027-07-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05704361

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Expanded Disability Status Scale (EDSS) score ≤7.0 at Screening * Participants with relapsing multiple sclerosis (RMS) or progressive multiple sclerosis (PMS) who fulfil international panel criteria for diagnosis (McDonald 2017 criteria) * Participants not treated with any approved MS treatment at Screening and not planning to start on any MS therapy during the study (including follow-up) * Female participants must practice abstinence or otherwise use contraception	* Evidence of clinical disease activity as defined by any clinical relapse within 3 months prior to screening, or by \>1 clinical relapse within 12 months prior to screening * Evidence of magnetic resonance imaging (MRI) activity as defined by the presence of ≥ 1 Gadolinium (Gd)-enhancing T1 lesion in the screening MRI scan or by ≥ 4 new or enlarging T2 lesions in the screening scan as compared to a reference scan * Participants who have active progressive multifocal leukoencephalopathy (PML), have had confirmed PML, or have a high degree of suspicion for PML * Known presence of other neurological disorders that may mimic MS including but not limited to: neuromyelitis optica spectrum disease, Lyme disease, untreated Vitamin B12 deficiency, neurosarcoidosis, cerebrovascular disorders, and untreated hypothyroidism * Known active or uncontrolled bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds, including participants exhibiting symptoms consistent with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 6 weeks prior to Day 1 * Participants with a current diagnosis of epilepsy * Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, or other major diseases * History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening. Basal or squamous cell carcinoma of the skin that has been excised and is considered cured and in situ carcinoma of the cervix treated with apparent success by curative therapy \>1 year prior to screening is not exclusionary * Any concomitant disease that may require treatment with systemic corticosteroids or immunosuppressants during course of the study * History of currently active primary or secondary (non-drug-related) immunodeficiency * History of hypersensitivity to biologic agents or any of the excipients in the formulation * Only for cohorts where CSF samples are planned to be collected: Participants with a history of spinal cord compression, raised intra-cerebral pressure, clinically significant vertebral joint pathology or any other current abnormalities in the lumbar region which could prevent the lumbar puncture procedure. * Treatment with any approved MS treatment at Screening. Participants may become eligible after completion of a washout period prior to acquiring any screening laboratory tests but should not be withdrawn from therapies for the sole purpose of meeting eligibility for the trial * Previous treatment with RO7121932, alemtuzumab, cladribine, mitoxantrone, cyclophosphamide, total body irradiation, bone marrow transplantation, and hematopoietic stem cell transplantation. For the USA only, previous treatment with daclizumab * Previous treatment with anti-cluster of differentiation 20 (CD20) B-cell-depleting therapies (e.g., rituximab, ocrelizumab, or ofatumumab) * \<12 months prior to acquiring any screening laboratory tests, * ≥12 months prior to acquiring any screening laboratory tests, if B-cells are outside the normal range, or not back to individual baseline ± 20% (if data are available), * If discontinuation of a prior B-cell depletion therapy was motivated by safety reasons * Current or prior treatment with natalizumab (if \<24 months prior to acquiring any screening laboratory tests) * Positive result on human immunodeficiency virus (HIV1) and HIV2, hepatitis C, or hepatitis B * Participants with SI or behavior within 6 months prior to Screening or participants who, in the Investigator's judgment, pose a suicidal or homicidal risk * Vaccination with a live or live-attenuated vaccine within 6 weeks prior to Day 1

Inclusion Criteria

Exclusion Criteria

* Expanded Disability Status Scale (EDSS) score ≤7.0 at Screening
* Participants with relapsing multiple sclerosis (RMS) or progressive multiple sclerosis (PMS) who fulfil international panel criteria for diagnosis (McDonald 2017 criteria)
* Participants not treated with any approved MS treatment at Screening and not planning to start on any MS therapy during the study (including follow-up)
* Female participants must practice abstinence or otherwise use contraception

* Evidence of clinical disease activity as defined by any clinical relapse within 3 months prior to screening, or by \>1 clinical relapse within 12 months prior to screening
* Evidence of magnetic resonance imaging (MRI) activity as defined by the presence of ≥ 1 Gadolinium (Gd)-enhancing T1 lesion in the screening MRI scan or by ≥ 4 new or enlarging T2 lesions in the screening scan as compared to a reference scan
* Participants who have active progressive multifocal leukoencephalopathy (PML), have had confirmed PML, or have a high degree of suspicion for PML
* Known presence of other neurological disorders that may mimic MS including but not limited to: neuromyelitis optica spectrum disease, Lyme disease, untreated Vitamin B12 deficiency, neurosarcoidosis, cerebrovascular disorders, and untreated hypothyroidism
* Known active or uncontrolled bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds, including participants exhibiting symptoms consistent with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 6 weeks prior to Day 1
* Participants with a current diagnosis of epilepsy
* Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, or other major diseases
* History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening. Basal or squamous cell carcinoma of the skin that has been excised and is considered cured and in situ carcinoma of the cervix treated with apparent success by curative therapy \>1 year prior to screening is not exclusionary
* Any concomitant disease that may require treatment with systemic corticosteroids or immunosuppressants during course of the study
* History of currently active primary or secondary (non-drug-related) immunodeficiency
* History of hypersensitivity to biologic agents or any of the excipients in the formulation
* Only for cohorts where CSF samples are planned to be collected: Participants with a history of spinal cord compression, raised intra-cerebral pressure, clinically significant vertebral joint pathology or any other current abnormalities in the lumbar region which could prevent the lumbar puncture procedure.
* Treatment with any approved MS treatment at Screening. Participants may become eligible after completion of a washout period prior to acquiring any screening laboratory tests but should not be withdrawn from therapies for the sole purpose of meeting eligibility for the trial
* Previous treatment with RO7121932, alemtuzumab, cladribine, mitoxantrone, cyclophosphamide, total body irradiation, bone marrow transplantation, and hematopoietic stem cell transplantation. For the USA only, previous treatment with daclizumab
* Previous treatment with anti-cluster of differentiation 20 (CD20) B-cell-depleting therapies (e.g., rituximab, ocrelizumab, or ofatumumab)
* \<12 months prior to acquiring any screening laboratory tests,
* ≥12 months prior to acquiring any screening laboratory tests, if B-cells are outside the normal range, or not back to individual baseline ± 20% (if data are available),
* If discontinuation of a prior B-cell depletion therapy was motivated by safety reasons
* Current or prior treatment with natalizumab (if \<24 months prior to acquiring any screening laboratory tests)
* Positive result on human immunodeficiency virus (HIV1) and HIV2, hepatitis C, or hepatitis B
* Participants with SI or behavior within 6 months prior to Screening or participants who, in the Investigator's judgment, pose a suicidal or homicidal risk
* Vaccination with a live or live-attenuated vaccine within 6 weeks prior to Day 1

Contacts and Locations

Study Contact

Reference Study ID Number: BP42230 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Hoffmann-La Roche

Study Locations (Sites)

Stanford University Medical Center

Stanford, California, 94305

United States

Yale University Multiple Sclerosis Center

New Haven, Connecticut, 06473

United States

University of South Florida

Tampa, Florida, 33612

United States

University of Massachusetts Medical School

Worcester, Massachusetts, 01655

United States

UC Health, LLC.

Cincinnati, Ohio, 45267

United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-11

Study Completion Date2027-07-08

Study Record Updates

Study Start Date2021-08-11

Study Completion Date2027-07-08

Terms related to this study

Additional Relevant MeSH Terms

Multiple Sclerosis