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Monoclonal Antibodies

RO7303509 for Systemic Sclerosis

Phase 1

Recruiting

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

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

Must have

Weight of 45-150 kg at screening

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 17 months

Awards & highlights

Study Summary

This trial will evaluate the safety and tolerability of RO7303509 in people with systemic sclerosis. The MAD stage will last 12 weeks, with a 9-week safety follow-up or 52-week open-label safety extension.

Who is the study for?

This trial is for adults weighing 45-150 kg with systemic sclerosis diagnosed within the last 10 years. They must not have severe lung, liver, kidney, heart or other major health issues and agree to use effective contraception. Excluded are those with significant pulmonary disease, positive tests for certain viruses like HIV or hepatitis B/C, recent or upcoming major surgery, pregnancy/breastfeeding women, and those with other active autoimmune diseases.Check my eligibility

What is being tested?

The study is testing RO7303509's safety and how the body processes it in people with systemic sclerosis over a period of up to 65 weeks. Participants will receive increasing doses of RO7303509 or placebo during a first phase (12 weeks), followed by an optional long-term safety extension where everyone gets RO7303509.See study design

What are the potential side effects?

Potential side effects aren't specified but may include reactions related to immune system activation such as allergic responses due to the drug being a monoclonal antibody. Regular monitoring will assess any adverse effects on organ function and general health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My weight is between 45 and 150 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 17 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 17 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 17 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Test Results

Electrocardiogram

Number of Participants With Clinically Significant Change From Baseline in Vital Signs

+1 more

Secondary outcome measures

MAD Stage: Area Under the Concentration vs Time Curve (AUC) of RO7303509

MAD Stage: Half-Life (t1/2) of RO7303509

MAD Stage: Maximum Serum Concentration (Cmax) of RO7303509

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: OSE StageExperimental Treatment1 Intervention

Every participant in the OSE stage will receive study drug and no participant will receive placebo. Participants will receive RO7303509 as SC injection at the same dose as that administered during the MAD stage, one time per month for up to a year.

Group II: MAD StageExperimental Treatment2 Interventions

Participants will be randomized in a ratio of 4:1 to receive RO7303509 or placebo, as subcutaneous (SC) injection, one time per month for 3 months. You have a 20% chance of getting placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,541 Previous Clinical Trials

568,043 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,840 Total Patients Enrolled

Media Library

RO7303509 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05462522 — Phase 1

Systemic Sclerosis Research Study Groups: OSE Stage, MAD Stage

Systemic Sclerosis Clinical Trial 2023: RO7303509 Highlights & Side Effects. Trial Name: NCT05462522 — Phase 1

RO7303509 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05462522 — Phase 1

Frequently Asked Questions

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

Has RO7303509 been verified by the Federal Drug Administration?

"Our team assigned RO7303509 a score of 1, as there is scant evidence supporting its safety and efficacy since this is only a Phase 1 trial."

Answered by AI

Does this research accept volunteers of advanced age?

"According to the study's inclusion criteria, only those between 18 and 75 years old can apply. There are 46 separate trials for individuals under 18, while 374 different clinical studies accept participants over 65."

Answered by AI

How many participants can this trial accommodate?

"Affirmative. On clinicaltrials.gov, the information indicates that this investigation is currently recruiting patients. The trial was first made available on October 31st 2022 and has recently been revised on October 19th 2022; it seeks to enlist 100 volunteers across 2 sites for further participation."

Answered by AI

Am I eligible to register for this experiment?

"To be eligible for this scleroderma trial, applicants must have diffuse form of the condition and should fall between 18 - 75 years old. Roughly 100 persons are needed to partake in this study."

Answered by AI

Is enrollment for this research experiment still ongoing?

"Clinicaltrials.gov reveals that, since its initial posting on October 31st 2022, this trial has been actively recruiting participants. The research was most recently modified by the team of investigators on October 19th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis

2023. "A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05462522.

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