Clinical Trials

Date: 2018-09-10

Type of information: Initiation of the trial

phase: 4

Announcement: initiation of the trial

Company: Eli Lilly (USA - IN)

Product: Taltz® (ixekizumab) and Tremfya® (guselkumab)

Action mechanism:

monoclonal antibody. Tremfya® (guselkumab) is a human monoclonal antibody that targets interleukin (IL)-23, a cytokine that plays a key role in plaque psoriasis. This antibody was generated utilizing the HuCAL antibody library technology licensed from MorphoSys.
Taltz® (ixekizumab) is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Taltz® inhibits the release of pro-inflammatory cytokines and chemokines.

Disease: moderate to severe chronic plaque psoriasis

Therapeutic area: Autoimmune diseases - Dermatological diseases

Country:

Trial details:

The purpose of the IXORA-R study is to compare the efficacy and safety of ixekizumab to guselkumab in participants with moderate-to-severe plaque psoriasis. The study, which is set to be completed by the end of 2019, aims to enroll 960 patients and is a 24-week multicenter, randomized, blinded, parallel-group study comparing the efficacy and safety of Taltz® to Tremfya® in patients with moderate-to-severe plaque psoriasis.
The primary endpoint of the study is the proportion of patients who achieve 100% improvement from their baseline as measured by PASI 100 at week 12.
Secondary endpoints include: the proportion of patients achieving PASI 75 as early as week 2 and PASI 100 at weeks 4, 8 and 24; and the proportion of patients achieving a Static Physician Global Assessment (sPGA) score of 0 at week 12.
(NCT03573323)

Latest news:

• On September 10, 2018, Eli Lillyannounced the initiation of the IXORA-R head-to-head (H2H) clinical trial, designed to evaluate superiority between Taltz® (ixekizumab) and Tremfya® (guselkumab) in adult patients with moderate-to-severe plaque psoriasis.
The IXORA-R study will be the first H2H trial between an IL-17 and IL-23 using the Psoriasis Area Severity Index (PASI) 100 score as the primary endpoint. This study is part of the expansive clinical development program for Taltz in psoriatic disease. In addition to IXORA-R, SPIRIT-H2H (NCT03151551)is a head-to-head clinical trial comparing Taltz to Humira® (adalimumab) in adult patients with psoriatic arthritis, which is scheduled to be completed in early 2019.
The Taltz safety profile has been studied in 12 clinical trials in moderate-to-severe plaque psoriasis with a total exposure of more than 15,000 patient-years and four clinical trials in psoriatic arthritis with more than 1,300 patient-years as part of the Taltz clinical trial program.