Phase 3 study of Baricitinib in patients with SLE
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled,Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus
IRAS ID
249357
Contact name
David D'Cruz
Contact email
david.d'cruz@kcl.ac.uk
Sponsor organisation
Eli Lilly and Company
Eudract number
2017-005026-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 10 days
Research summary
This is a clinical research study of a potential new treatment called baricitinib in participants with Systemic Lupus Erythematosus (SLE).\n\nSystemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that damages the body’s cells and tissues. Baricitinib is a drug that blocks the effects of certain proteins in the body that may cause SLE. The reason for this study is to see how effective and safe baricitinib is in participants with SLE.\n\nThis study will include a total of 750 participants, with approximately 15 participants from 3 sites expected in the UK. Study participation will last up to 62 weeks, which is approximately 14 months. The study is divided into three separate periods: Screening period – lasting up to 6 weeks, study treatment period lasting 52 weeks and short-term follow-up period lasting up to 4 weeks.\n\nStudy participants will be placed into one of three treatment groups in a 1:1:1 ratio:\t\n•\tBaricitinib 2mg once daily\n•\tBaricitinib 4mg once daily\n•\tPlacebo once daily\nParticipants will have a 2 in 3 chance of receiving baricitinib.\n\nThe study involves procedures including: physical examination, vital signs, blood tests, electrocardiogram (ECG), chest X-ray and questionnaires.\t\n\nThis study is sponsored by Eli Lilly and Company.\n\n
REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/1946
Date of REC Opinion
24 Dec 2018
REC opinion
Further Information Favourable Opinion