ATACICEPT (VT-001)
Research type
Research Study
Full title
A Phase 3 Randomized, Double-blind, Placebo-Controlled Multicenter, Multinational, 52-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with Active Lupus Nephritis.
IRAS ID
1005466
Contact name
Celia Lin
Contact email
Sponsor organisation
Vera Therapeutics, Inc
Eudract number
2022-000257-83
Clinicaltrials.gov Identifier
Research summary
This is a placebo-controlled, double-blind study. Placebo-controlled provides a way to measure the actual effect of the investigational drug (atacicept). Double-blind means that the participant and the study doctor will not know if they are getting atacicept or placebo.
In this research study, an investigational drug called atacicept is being tested for the treatment of active lupus nephritis. Atacicept works by blocking two proteins in the immune system that may improve symptoms and/or signs of lupus nephritis. Atacicept has not been approved for use by government agencies in any county, as a treatment for any condition.
In this study, participants will either receive atacicept or placebo (which looks like the investigational drug, but does not contain any active ingredients).
The main purpose of this study is to see if weekly injections of atacicept can decrease the damage to kidneys and improve kidney function, compared to placebo after 52 weeks of treatment. Another purpose of the study is to measure how well atacicept works on kidneys and whether it improves quality of life after 104 weeks compared to placebo.
This study will include approximately 360 participants across North America, Latin America, Europe, and Asia.
Participants will take part in the study up to 156 weeks broken down into 4 time periods – Screening Period, Double-Blind Treatment Period, Open-Label Treatment Period, and Follow-Up Period.
The total study duration for each participant will be up to 186 weeks.REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0461
Date of REC Opinion
21 Jun 2023
REC opinion
Further Information Favourable Opinion