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Monoclonal Antibodies

RO7121932 for Multiple Sclerosis

Phase 1

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose and post dose at 0.5 hour, 1 hour (or end of infusion), 2 hour, 3 hour (or end of infusion), 8 hour on day 1, and on days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 169

Awards & highlights

Study Summary

This trial studies if a drug is safe and tolerable for people with multiple sclerosis (MS).

Who is the study for?

This trial is for adults with multiple sclerosis (MS) who haven't used any approved MS treatments at screening and won't start during the study. They should have an EDSS score ≤7.0, meet McDonald 2017 criteria for MS diagnosis, and use contraception if female. Excluded are those with recent MS activity, other neurological disorders that mimic MS, active infections including COVID-19 within 6 weeks prior to Day 1, history of cancer in the last 10 years (except certain skin cancers), or a history of severe allergies to biologic agents.Check my eligibility

What is being tested?

The trial is testing RO7121932 given through IV to see how safe it is and how well participants with MS tolerate it. The focus is on single ascending doses to determine reactions and body processing.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones from similar trials may include injection site reactions, flu-like symptoms such as fever or chills, potential allergic reactions, fatigue, headache or possible changes in liver function tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose and post dose at 0.5 hour, 1 hour (or end of infusion), 2 hour, 3 hour (or end of infusion), 8 hour on day 1, and on days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 169

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose and post dose at 0.5 hour, 1 hour (or end of infusion), 2 hour, 3 hour (or end of infusion), 8 hour on day 1, and on days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 169

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose and post dose at 0.5 hour, 1 hour (or end of infusion), 2 hour, 3 hour (or end of infusion), 8 hour on day 1, and on days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 169 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change From Baseline in Suicide Risk as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)

Percentage of Participants With Abnormal Laboratory Findings

Percentage of Participants With Abnormal Vital Signs and Electrocardiogram (ECG) Parameters

+1 more

Secondary outcome measures

AUC From Time 0 to Infinity (AUCinf)

Apparent Terminal Half-Life (T1/2) of RO7121932

Area Under the Serum Concentration-Time Curve From Time 0 to 168 Hours (h) (AUC0-168h) Postdose

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: RO7121932: Dose Escalation Cohorts 1 to 6Experimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,431 Previous Clinical Trials

1,090,005 Total Patients Enrolled

34 Trials studying Multiple Sclerosis

24,966 Patients Enrolled for Multiple Sclerosis

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,877 Total Patients Enrolled

35 Trials studying Multiple Sclerosis

18,293 Patients Enrolled for Multiple Sclerosis

Media Library

RO7121932 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05704361 — Phase 1

Multiple Sclerosis Clinical Trial 2023: RO7121932 Highlights & Side Effects. Trial Name: NCT05704361 — Phase 1

RO7121932 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05704361 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the trial open to young adults, or is there an age limit?

"Eligibility criteria for this clinical trial dictate that the lower age limit is 18 and the upper age limit is 65."

Answered by AI

How many sites are hosting this clinical inquiry?

"Currently, 5 distinct sites are recruiting patients for this clinical trial. These include New Haven, Tampa and Worcester as well as two other locations. To relieve any travel demands, individuals should select the nearest site to them before enrolling in this study."

Answered by AI

How many subjects are enrolled in this clinical experiment?

"Hoffmann-La Roche, the sponsor of this trial, requires a total enrollment of 63 compliant patients across multiple sites. Notably, Yale University Multiple sclerosis Center in New Haven and University of South Florida in Tampa will be hosting the research."

Answered by AI

Are there any vacancies left in this research study for participants?

"The research project, which was initially listed on August 11th 2021, is currently recruiting participants as noted by clinicaltrials.gov's records of the trial and the most recent update made on January 19th 2023."

Answered by AI

Has RO7121932: Dose Escalation Cohorts 1 to 6 been greenlighted by the FDA?

"The safety of RO7121932: Dose Escalation Cohorts 1 to 6 is rated a 1 due to the preliminary nature of this Phase 1 trial, as there is minimal data available in terms of efficacy and security."

Answered by AI

What criteria make an individual a suitable candidate for this experiment?

"This medical trial is open to 63 individuals with a Multiple sclerosis diagnosis between the ages of 18 and 65. Furthermore, applicants must satisfy Expanded Disability Status Scale (EDSS) score ≤7.0 at Screening, have non-active relapsing MS or progressive MS that fulfills international panel criteria for diagnosis as per revised McDonald 2017 criteria (Thompson 2018), Lublin et al 2014 (Lublin et al 2020) and other exclusion criterion 1 factors; not be on approved treatments during screening or planning to start any therapies during study period; female participants must practice abstinence or use contraception methods."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous RO7121932 in Participants With Multiple Sclerosis.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05704361.

All > Multiple Sclerosis