A Phase 1b Study to Evaluate the Safety of RO7303509 in Patients with Systemic Sclerosis
Research type
Research Study
Full title
PHASE Ib, DOUBLE-BLIND, RANDOMIZED,PLACEBO-CONTROLLED, MULTICENTERSTUDY TO EVALUATE THE SAFETY,TOLERABILITY, AND PHARMACOKINETICS OFMULTIPLE-ASCENDING DOSES OF RO7303509IN PATIENTS WITH SYSTEMIC SCLEROSIS
IRAS ID
1005141
Contact name
Eric Olson
Contact email
Sponsor organisation
Genentech InC
Eudract number
2021-004578-68
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to test new potential treatments for systematic sclerosis. The study is testing a clinical treatment with experimental drug RO7303509 at different doses to find out if it is safe and to understand the way your body processes the drug. Another purpose of this clinical research is to study the long-term safety and effects of RO7303509. The goal is to find a safe and accepted dose of RO7303509 in people with systemic sclerosis.
RO7303509 is an experimental drug that is being developed for treating people with systemic sclerosis.
The study has two stages: The multiple-ascending dose (MAD) stage and an optional long-term open-label safety extension (OSE) stage. All participants who qualify and agree to be in this study will enter the MAD stage.For full details of the study in lay language please refer to the Main Participant Information Sheet and Informed Consent Form.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
22/EE/0212
Date of REC Opinion
17 Nov 2022
REC opinion
Further Information Favourable Opinion