I1F-MC-RHBF Ixekizumab in patients with active psoriatic arthritis
Research type
Research Study
Full title
A Phase 3, Multicenter Study with a 36-Week Open-Label Period Followed by a Randomized Double-Blind Withdrawal Period from Week 36 to Week 104 to Evaluate the Long Term Efficacy and Safety of Ixekizumab (LY2439821) 80 mg Every 2 Weeks in Biologic Disease-Modifying Antirheumatic Drug–Naive Patients with Active Psoriatic Arthritis
IRAS ID
188695
Contact name
Hasan Tahir
Contact email
Sponsor organisation
Eli Lilly & Company
Eudract number
2015-002433-22
Duration of Study in the UK
3 years, 0 months, 10 days
Research summary
Psoriatic Arthritis (PsA) is a form of Arthritis that people with Psoriasis (Ps) may get. Some people have swelling or tenderness in their joints, and others can also get it in their spine. This study initially is open label (period 2), this means that the investigator and the study participant are aware of the treatment being received during this part of the study. This is followed by a randomised double blind withdrawal (period 3), which a process of assigning patients to an experimental group on a random basis and in which one or more parties to the trial are kept unaware of the treatment assignment neither the patient nor any of the investigator or sponsor staff who are involved in the treatment or clinical evaluation of the subjects are aware of the treatment received. The patients selected for this study will be equal to or greater than 18 years old.
Interleukin17 (IL17) is a proinflammatory cytokine produced by a type of white blood cell called a T helper cell. IL17 is involved in defense against certain types of infections, but uncontrolled IL17 production may be involved in certain diseases including PsA and there are several pieces of evidence linking IL17 to the pathology in PsA.
Ixekizumab (LY2439821) is a humanized monocloncal antibody that is being developed for the treatment of patients with PsA. Ixekizumab has a high affinity for IL17 and blocks the activity of IL17 by preventing it from binding to the IL17 receptor (IL17R).
This multicentre study has an initial open label treatment period (2) of 36 weeks where all patients will be given the Ixekizumab and its effects will be examined in patients with active Psoriatic Arthritis (PsA). Then the main objective of this study is to compare Ixekizumab and placebo in maintenance of treatment response, as measured by the time to relapse during the randomised double blind withdrawal period (3) week 36 (visit 12) to week 64 (Visit 19) in conventional Disease-Modifying Antirheumatic Drug (cDMARD)-inadequate responder (IR) and biological bDMARD-naïve patients with active (PsA) who meet Coates criteria for Minimal Disease Activity (MDA) for 3 consecutive months over 4 consecutive visits. . The study lasts for 2 years consisting of 4 periods: Period 1 Screening (4 -30 days), period 2 treatment of study drug (36 week), period 3 the randomised double blind withdrawal period (week 36-104) treatment of study drug or placebo and Period 4 post treatment follow up (week 12 or 24).REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
15/YH/0484
Date of REC Opinion
27 Nov 2015
REC opinion
Further Information Favourable Opinion