Lilly Announces Initiation of IXORA-R Head-to-Head Trial Comparing Taltz and Tremfya in Patients with Moderate-to-Severe Plaque Psoriasis

日期:2018-09-14 来源:Eli Lilly and Company

Eli Lilly and Company (NYSE: LLY) announced 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.


"Lilly is committed to minimizing the burden for people with immune-mediated inflammatory diseases, including moderate-to-severe plaque psoriasis," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "Head-to-head trials can provide robust evidence that helps advance clinical practice. We hope the results of this new study will provide valuable insights to patients and their providers."


The IXORA-R 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.


"The primary endpoint of this study is PASI 100, which emphasizes that the goal of treatment should be complete skin clearance," said Alice Gottlieb, M.D., Ph.D., Professor of Dermatology at New York Medical College. "This study could help raise awareness of treatment goals for moderate-to-severe plaque psoriasis that patients can explore with their doctors."


IXORA-R is part of the expansive clinical development program for Taltz in psoriatic disease. In addition to IXORA-R, SPIRIT-H2H 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.1,2,3


reference

1.Data on File [t_tea1ptex_safety_aps]. Eli Lilly and Company 2017.

2.Data on File [t_teaesocex_safety_aps]. Eli Lilly and Company 2016.

3.Philippe Goupille, Euthalia Roussou, Gerd-Rüdiger Burmester, Philip Mease, Alice Gottlieb, Sandra Garces, Olivier Benichou,David H. Adams, Wen Xu, Peter Nash. Safety of Ixekizumab in Patients with Psoriatic Arthritis: Results from a Pooled Analysis of Three Clinical Trials. Ann Rheum Dis. 2018;77(Suppl 2):1039-1040.

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