JAIM - Phase 3 extension study of Baricitinib in patients with SLE
Research type
Research Study
Full title
A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)
IRAS ID
261027
Contact name
David D'Cruz
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2017-005028-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 5 months, 29 days
Research summary
Summary of Research
This is a clinical research study of a potential new treatment called baricitinib in participants with Systemic Lupus Erythematosus (SLE).Systemic 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 safe and effective long-term treatment with baricitinib is in participants with SLE. Participants who completed the treatment period in the I4V-MC-JAHZ/JAIA studies (UK is taking part in the JAHZ study only) will be invited to take part in this extension study (I4V-MC-JAIM).
This study will include a total of approximately 1100 participants, with approximately 15 participants from 3 sites expected in the UK. Study participation will last up to 3 years, with a total of up to 16 visits to the study site. The study is divided into two separate periods: Treatment Period – lasting up to 156 weeks, followed by a short-term follow-up period lasting up to 4 weeks. Visit 1 of JAIM study will be performed on the same day as the last visit for the JAHZ study, and assessments/procedures for both visit 1 of JAIM and the final visit of JAHZ should only be performed once.
Participants who received active treatment, baricitinib 4mg or 2mg daily during JAHZ study will continue on the same blinded dose of baricitinib in the JAIM study. Participants who were randomised to placebo during study JAHZ will be randomised 1:1 to receive either baricitinib 4mg or 2mg daily during in study JAIM.
The study involves procedures including: physical examination, vital signs, blood and urine tests, and questionnaires.
This study is sponsored by Eli Lilly and Company.
Summary of Results
For JAIA, the primary endpoint (SRI-4 at Week 52) was not met; for JAHZ, The primary endpoint (SRI-4 at Week 52) was met for the baricitinib 4 mg group (p=0.016), however no major secondary endpoints were met at either dose.
Due to the results of these two main studies, JAHZ and JAIA, Eli Lilly and Company decided not to continue with the long term study, JAIM. In addition, no new safety concerns were discovered.REC name
East of Scotland Research Ethics Service REC 2
REC reference
19/ES/0100
Date of REC Opinion
24 Oct 2019
REC opinion
Further Information Favourable Opinion