RO7303509 for Systemic Sclerosis

Recruiting at 46 trial locations

Overseen By Reference Study ID Number: GA43360 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Genentech, Inc.

Must not be taking: Disease-modifying therapy

Disqualifiers: Pulmonary disease, Metabolic disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called RO7303509 in people with systemic sclerosis. The study will give patients increasing doses of the drug to see how their bodies react and to make sure it is safe. The trial includes a treatment period followed by a safety check or an extended safety phase.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an active rheumatic autoimmune disease other than systemic sclerosis that requires treatment with disease-modifying therapy, you may be excluded from participating.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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.

Inclusion Criteria

I completed the initial study phase and can start the next phase within 5 days.

No clinically significant change in eligibility status

My weight is between 45 and 150 kg.

Exclusion Criteria

I am being treated for an autoimmune disease other than systemic sclerosis.

I do not have any serious medical conditions or abnormal lab test results.

My lung function is less than half of what it should be.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RO7303509 or placebo as subcutaneous injection once a month for 12 weeks in the MAD phase

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment with RO7303509 for long-term safety assessment

52 weeks

Treatment Details

Interventions

• RO7303509

Trial Overview 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.

Participant Groups

Group I: OSE Stage Experimental Treatment 1 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 Stage Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD