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A Study of Ixekizumab (LY2439...

A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

Last Updated: 2020-11-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

566 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-24

Study Completion Date

2019-09-04

Brief Summary

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The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.

Detailed Description

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Conditions

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Psoriatic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ixekizumab

160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline for all participants.

80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.

80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.

Group Type EXPERIMENTAL

Ixekizumab

Intervention Type DRUG

Administered SC

Adalimumab

80 mg adalimumab given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.

40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.

Group Type ACTIVE_COMPARATOR

Adalimumab

Intervention Type DRUG

Administered SC

Interventions

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Ixekizumab

Administered SC

Intervention Type DRUG

Adalimumab

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY2439821

Eligibility Criteria

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Inclusion Criteria

* Presence of established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
* Active PsA defined as the presence of at least 3 (out of 68) tender and at least 3 (out of 66) swollen joints
* Presence of active plaque psoriasis with a BSA ≥3%
* 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
* Have had an inadequate response when treated with 1 or more conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)

Exclusion Criteria

* Current or prior use of biologic agents for treatment of Ps or PsA
* 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 last 3 months
* Active Crohn's disease or active ulcerative colitis
* Active vasculitis or uveitis
* Diagnosis of or history of malignant disease \<5 years prior to randomization
* Women who are breastfeeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Atencion Integral en Reumatología

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Site Status

Clinica Adventista de Belgrano

Ciudad de Buenos Aires, Buenos Aires, Argentina

Site Status

CER Instituto Medico

Quilmes, Buenos Aires, Argentina

Site Status

Instituto de Asist Reumatologica Integral

San Fernando, Buenos Aires, Argentina

Site Status