NCT05462522

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

A Phase Ib, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of RO7303509 in Participants With Systemic Sclerosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RO7303509 treatment in participants with systemic sclerosis (SSc) during a multiple-ascending-dose (MAD) portion of the trial. In the MAD phase, increasing doses of study drug will be tested sequentially. For each dose tested, the MAD stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 13 weeks or continued treatment in an optional open-label safety extension (OSE) stage of 52 weeks to assess the long-term safety. All patients in the OSE stage will receive RO7303509 and no patient will receive placebo.

Conditions

• Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	RO7303509	RO7303509 will be administered as SC injection monthly, as specified in each treatment group.
DRUG	Placebo	RO7303509 matching placebo will be administered as SC injection monthly, during the MAD stage.

Timeline

• Start date: 2023-01-16
• Primary completion: 2025-07-11
• Completion: 2025-07-11
• First posted: 2022-07-18
• Last updated: 2025-07-20

Locations

25 sites across 11 countries: United States, Argentina, Belgium, France, Israel, Poland, Portugal, Puerto Rico, Serbia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study