Phase 3 study to evaluate efficacy and safety of RO7434656 in patients with high risk IgAN
Research type
Research Study
Full title
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of RO7434656, an Antisense Inhibitor of Complement Factor B, in Patients with Primary IgA Nephropathy at High Risk of Progression
IRAS ID
1007821
Contact name
Head, EU / International Pharmaceuticals Division
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Clinicaltrials.gov Identifier
Research summary
This is a phase 3, multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of the study drug "RO7437656". The purpose of this study is to compare the effects either good or bad of the study drug and a placebo in participants with IgA Nephropathy (IgAN) who are at high risk of progressive kidney disease optimised supportive care.
IgAN is the most widespread long-term acute inflammation of the kidney, typically caused by an immune response and is an important cause of chronic kidney disease and kidney failure.
The study will last approximately 2 years and will have approximately 428 participants total worldwide, including the UK.
Participants will be put into either the study drug group or placebo group randomly, each participant will have an equal chance (1:1) of being assigned to the study drug group or placebo group. This assignment is also known as "blinded treatment" as neither participant nor the study site staff will know which treatment group the participant will be assigned to.
The study drug or placebo will be given as a subcutaneous (under the skin) injection every 2 weeks for the first 3 doses and then every 4 weeks for about 2 years. During this study, participants will need to visit the study site (hospital) approximately every 2 to 12 weeks while receiving treatment. Visits may last 1 to 10 hours. A typical visit will last approximately 2 to 3 hours.
During 6 months of close monitoring, the study doctor will assess whether there is improvement in the participant’s condition. The study doctor will then decide to either discontinue or continue the treatment for the participant. Each participant will return for a safety follow-up visit about 3 months after the final dose of the study drug.
Sponsor may decide to halt the study if the results indicate a lack of efficacy.REC name
West of Scotland REC 1
REC reference
23/WS/0140
Date of REC Opinion
12 Oct 2023
REC opinion
Further Information Favourable Opinion