A Study of Ixekizumab in Participants With Active Psoriatic Arthritis

Conditions

Arthritic Psoriasis MedDRA version: 15.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859

Vinod Chandran, Désirée van der Heijde, Roy Fleischmann, Éric Lespessailles, Philip Helliwell et al. (13 authors)

Lara D. Veeken2020-01-0251 citations

10.1093/rheumatology/kez684

Ixekizumab improves patient-reported outcomes up to 52 weeks in bDMARD-naïve patients with active psoriatic arthritis (SPIRIT-P1)

Alice B. Gottlieb, Vibeke Strand, Mitsumasa Kishimoto, Philip J. Mease, Diamant Thaçi et al. (10 authors)

Lara D. Veeken2018-05-2231 citations

10.1093/rheumatology/key161

Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis: 52-week Results from a Phase III Study (SPIRIT-P1)

Désirée van der Heijde, Dafna D. Gladman, Mitsumasa Kishimoto, Masato Okada, Suchitrita S. Rathmann et al. (10 authors)

The Journal of Rheumatology2017-12-15122 citations

10.3899/jrheum.170429

Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1.

Mease PJ, van der Heijde D, Ritchlin CT, Okada M, Cuchacovich RS, Shuler CL, Lin CY, Braun DK, Lee CH, Gladman DD, SPIRIT-P1 Study Group.

2016-08-23404 citations

10.1136/annrheumdis-2016-209709

Interventions

Product Name: Ixekizumab Product Code: LY2439821 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Ixekizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Presents with established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria • Active psoriatic arthritis (PsA) defined as the presence of at least 3 tender and at least 3 swollen joints • Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps) • Men must agree to use a reliable method of birth control or remain abstinent during the study • Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 392 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: • Current or prior use of biologic agents for treatment of Ps or PsA • Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDs) • Current use of more than one conventional DMARD • Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA • Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab • Serious disorder or illness other than psoriatic arthritis • Serious infection within the 3 months prior to randomization • Breastfeeding or nursing (lactating) women

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on ACR20 at 24 Weeks; Secondary Objective: · Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on modified Total Sharp Score (mTSS) through 24 weeks · Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on ACR20 through 24 Weeks · Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on Non-Arthritic Disease Assessments through 24 Weeks · Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on Patient Reported Outcomes (PROs) through 24 Weeks ;Primary end point(s): American College of Rheumatology 20 Index (ACR20);Timepoint(s) of evaluation of this end point: At 24 Weeks	—

Measure

Time frame

Main Objective: Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on ACR20 at 24 Weeks; Secondary Objective: · Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on modified Total Sharp Score (mTSS) through 24 weeks · Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on ACR20 through 24 Weeks · Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on Non-Arthritic Disease Assessments through 24 Weeks · Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on Patient Reported Outcomes (PROs) through 24 Weeks ;Primary end point(s): American College of Rheumatology 20 Index (ACR20);Timepoint(s) of evaluation of this end point: At 24 Weeks

—

Secondary

Measure	Time frame
Secondary end point(s): · modified Total Sharp Score (mTSS) · ACR20 · Non-Arthritic Disease Assessments · Patient Reported Outcomes (PRO) ;Timepoint(s) of evaluation of this end point: Baseline through 24 Weeks	—

Countries

Argentina, Belgium, Bulgaria, Canada, Czech Republic, Estonia, France, Hungary, Ireland, Japan, Mexico, Netherlands, Poland, Russian Federation, South Africa, Spain, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactClinical Trial Information

Eli Lilly

EU_Lilly_clinical_Trials@Lilly.com

Outcome results

None listed