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

Part of paid clinical trials in Stanford, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT05704361
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • RO7121932 IV — DRUG
    Participants will receive RO7121932, as an IV infusion, per the schedule specified in the treatment arms.
  • RO7121932 SC — DRUG
    Participants will receive RO7121932, as SC injection, per the schedule specified in the treatment arms.

Study Details

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).

Key Dates

Start date
Aug 11, 2021
Status verified
May 2026
Primary completion
Jul 8, 2027
Completion
Jul 8, 2027

Study Design

Enrollment
129 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Single Ascending Dose (SAD) IV: RO7121932- Dose Escalation Cohorts 1 to 6 and Later Cohorts
    Participants will receive a single IV dose of RO7121932 on treatment Day 1. The planned starting dose of RO7121932 is 7 milligrams (mg) and will be escalated up to 2000 mg. The maximum dose will not exceed 4000 mg . Doses may be repeated, adjusted downwards, or intermediate doses may be investigated based on emerging data.
  • Experimental: Part 2: SAD SC: RO7121932- Dose Escalation Cohorts 1 to 2
    Participants will receive a single SC dose of RO7121932 on treatment Day 1. The planned starting dose of RO7121932 is 70 mg and will be escalated up to 200 mg. Doses may be repeated, adjusted downwards, or intermediate doses may be investigated based on emerging data.
  • Experimental: Part 3: Multiple Ascending Dose (MAD) SC: RO7121932- Dose Escalation Cohorts 1 to 3
    Participants will receive multiple SC doses of RO7121932, once weekly on treatment Day 1 through Day 22. The planned starting dose of RO7121932 is 70 mg and will be escalated up to 700 mg. Doses may be repeated, adjusted downwards, or intermediate doses may be investigated based on emerging data.

Primary Outcome Measure

Parts 1, 2, and 3: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) With Severity of AEs Measured According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE V5) [ Time Frame: Day 1 to Day 169 for Part 1 and Part 2; Day 1 to Day 197 for Part 3 ]

Central Contacts

  • Reference Study ID Number: BP42230 https://forpatients.roche.com/
    888-662-6728 (U.S. Only)
    [email protected]

Locations (5)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterStanfordCalifornia94305-
Yale University Multiple Sclerosis CenterNew HavenConnecticut06473-
University of South FloridaTampaFlorida33612-
University of Massachusetts Medical SchoolWorcesterMassachusetts01655-
UC Health, LLC.CincinnatiOhio45267-

Find similar trials in Stanford, CA

By condition
Multiple sclerosis
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By research site
Stanford University Medical Center· Stanford, CAYale University Multiple Sclerosis Center· New Haven, CTUniversity of South Florida· Tampa, FLUniversity of Massachusetts Medical School· Worcester, MAUC Health, LLC.· Cincinnati, OH

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