A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis

NCT03129100 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 773

Last updated 2022-06-13

Study results available
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Summary

The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.

Conditions

  • Axial Spondyloarthritis

Interventions

DRUG

Ixekizumab

Administered SC

DRUG

Placebo

Administered SC

Sponsors & Collaborators

Principal Investigators

  • 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) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-09
Primary Completion
2020-05-26
Completion
2021-05-27
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Brazil
  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03129100 on ClinicalTrials.gov