BP44315 Open-label Dose Escalation Phase 1 study of RO7507062 for Safety, PK, PD in SLE
Research type
Research Study
Full title
An Open-Label, Multicenter, Dose Escalation, First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered RO7507062 in Participants with Systemic Lupus Erythematosus
IRAS ID
1008472
Contact name
Head of Regulatory Management
Contact email
Sponsor organisation
F. Hoffman-La Roche AG
Eudract number
2022-502632-39
Research summary
Systemic Lupus Erythematosus (SLE is an autoimmune disease that occurs more commonly in women as compared to men (approximately 8.5:1;. It is a chronic disease characterized by flare-ups. SLE is a disease in which the immune system of the body mistakenly attacks healthy tissue. In SLE, auto-antibodies can be produced by a type of immune cell called B cells and these can cause harm to the skin, joints, kidneys, brain, and/or other organs of the body. RO7507062 is a man-made antibody that attaches to B cells and another type of immune cell at the same time, called T cells (which are a type of cell that protects the body from infection). RO7507062 is designed to activate T cells to reduce B cells, therefore decreasing the auto-antibody production by the B cells and associated damage.
The principle aim of this first in human Phase I study is to assess the safety, tolerability, and the pharmacokinetic (PK) and pharmacodynamics (PD) effects of subcutaneously (SC) administered RO7507062 in patients with SLE. The results of this trial will be used to support further clinical development of RO7507062 with possible expansions to other indications.
This study of RO7507062 will be conducted in two parts: Part 1 is a single ascending dose part to define the dose to be given on Day 1 of Part 2. Part 2 is a dose-escalation part of RO7507062. The total duration of the study for each participant, whether enrolled into Part 1 or Part 2 of the study, is expected to be a minimum of approximately 14 months (from Screening and including the safety and follow-up [SFU] period).
RO7507062 is an experimental drug and the Health Authorities (U.S. Food and Drug Administration and European Medicines Agency) have not approved RO7507062 for the treatment of SLE.
Approximately 70 people with SLE will take part in this study.The study is sponsored by F. Hoffman La Roche
Research Summary; Version Number 1 dated 13th February 2023
REC name
Wales REC 1
REC reference
23/WA/0245
Date of REC Opinion
8 Nov 2023
REC opinion
Further Information Favourable Opinion