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

Lilly

Status and phase: Completed; Phase 3

Conditions: Axial Spondyloarthritis

Treatments: Drug: Ixekizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03129100

16181

2016-002634-69 (EudraCT Number)

I1F-MC-RHBY (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 773 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have completed the final study visit in Study RHBV (NCT02696785), RHBW (NCT02696798), or RHBX (NCT02757352).

(Note: Participants from Study RHBX are not eligible if they permanently discontinued ixekizumab and were receiving a tumor necrosis factor [TNF] inhibitor).

• Must agree to use a reliable method of birth control.

Exclusion criteria

• Have significant uncontrolled disorders or abnormal laboratory values that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered.
• Have a known hypersensitivity to ixekizumab or any component of this investigational product.
• Had investigational product permanently discontinued during a previous ixekizumab study.
• Had temporary investigational product interruption at any time during or at the final study visit of a previous ixekizumab study and, in the opinion of the investigator, restarting ixekizumab poses an unacceptable risk for the participant's participation in the study.
• Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol.
• Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

773 participants in 3 patient groups, including a placebo group

Ixekizumab (IXE) 80Q4W

Experimental group

Description:

Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every four weeks (Q4W).

Treatment:

Drug: Ixekizumab

Ixekizumab (IXE) 80Q2W

Experimental group

Description:

Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every two weeks (Q2W).

Treatment:

Drug: Ixekizumab

Placebo

Placebo Comparator group

Description:

Participants received subcutaneous dose of placebo.

Treatment:

Drug: Placebo