M23-699: SELECT-SLE
Research type
Research Study
Full title
SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Moderately to Severely Active SLE
IRAS ID
1008107
Contact name
David D'Cruz
Contact email
Sponsor organisation
Abbvie Deutschland GmbH & Co. KG
Eudract number
2023-503655-10
Clinicaltrials.gov Identifier
Research summary
Systemic Lupus Erythematosus (SLE) is an
immune-mediated disease associated with inflammation of
multiple organ systems. This study will assess how safe and
effective upadacitinib is in treating adult participants with
moderately to severely active SLE. Adverse events and
change in the disease activity will be assessed.
Upadacitinib is an approved drug for rheumatoid arthritis,
psoriatic arthritis, and axial spondylarthritis and is being
developed for the treatment of SLE. This study is
"double-blinded", which means that neither the trial
participants nor the study doctors will know who will be
given upadacitinib and who will be given placebo (does not
contain treatment drug) . This study comprised of 3 sub
studies. In Study 1 and Study 2, study doctors put the
participants in 1 of the 2 groups, called treatment arms.
Each group receives a different treatment. There is a 1 in 2
chance that participants will be assigned to placebo.
Eligible participants from Study 1 and Study 2 will enter
Study 3 at week 52 to receive specific doses of upadacitinib
based on their disease activity and their original treatment
assignment in Study 1 or 2. Approximately 500 participants
diagnosed with SLE will be enrolled in each of the Study 1
and Study 2 in approximately 320 sites across the world.
Participants will receive oral tablets of upadacitinib or
matching placebo once daily for 52 weeks in Study 1 and
Study 2. Eligible participants from Study 1 and Study 2 will
receive oral tablets of upadacitinib once daily for 52 weeks
in Study 3.REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0682
Date of REC Opinion
7 Dec 2023
REC opinion
Further Information Favourable Opinion