Phase 3, multicenter, long-term extension study of 104 weeks in patients with axial spondyloarthritis

Protocol I1F-MC-RHBY A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients with Axial Spondyloarthritis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002634-69-ES

Enrollment

750

Registered

2016-11-18

Start date

2017-01-31

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axial Spondyloarthritis MedDRA version: 19.0 Level: LLT Classification code 10041672 Term: Spondylitis ankylosing System Organ Class: 100000004859

Interventions

Trade Name: Taltz Product Name: LY2439821 Product Code: IXEKIZUMAB Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ixekizumab Other descriptive name: LY2439821 C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Have completed the final study visit in Study RHBV, RHBW, or RHBX. (Note: Patients from Study RHBX are not eligible if they permanently discontinued ixekizumab and were receiving a TNF inhibitor). 2.Must agree to use a reliable method of birth control. 3.Have given written informed consent. 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 675 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75

Exclusion criteria

Exclusion criteria: -Have significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous ixekizumab study that, in the opinion of the investigator, pose an unacceptable risk to the patient 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 patient’s participation in the study. -Have any other condition that, in the opinion of the investigator, renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate in patients having achieved a state of sustained remission whether the ixekizumab treatment group is superior to the placebo group in maintaining response during the randomized-withdrawal period;Secondary Objective: -To compare the combined ixekizumab treatment group to historical control for 2-year radiographic progression in spine in patients with active radiographic axSpA -To evaluate in patients having achieved a state of sustained remission whether the ixekizumab 80 mg every 2 weeks (Q2W) treatment group or ixekizumab 80 mg every 4 weeks (Q4W) treatment group is superior to placebo in maintaining response -To evaluate in patients having achieved a state of sustained remission whether the combined ixekizumab treatment group is superior to the placebo group in maintaining response after treatment withdrawal -To evaluate in patients having achieved a state of sustained remission whether the ixekizumab 80 mg Q2W treatment group or ixekizumab 80 mg Q4W treatment group is superior to placebo in maintaining response after treatment withdrawal;Primary end point(s): The proportion of patients in the randomized withdrawal population who do not experience a flare during the randomized withdrawal retreatment period;Timepoint(s) of evaluation of this end point: Week 64	—

Measure

Time frame

Main Objective: To evaluate in patients having achieved a state of sustained remission whether the ixekizumab treatment group is superior to the placebo group in maintaining response during the randomized-withdrawal period;Secondary Objective: -To compare the combined ixekizumab treatment group to historical control for 2-year radiographic progression in spine in patients with active radiographic axSpA -To evaluate in patients having achieved a state of sustained remission whether the ixekizumab 80 mg every 2 weeks (Q2W) treatment group or ixekizumab 80 mg every 4 weeks (Q4W) treatment group is superior to placebo in maintaining response -To evaluate in patients having achieved a state of sustained remission whether the combined ixekizumab treatment group is superior to the placebo group in maintaining response after treatment withdrawal -To evaluate in patients having achieved a state of sustained remission whether the ixekizumab 80 mg Q2W treatment group or ixekizumab 80 mg Q4W treatment group is superior to placebo in maintaining response after treatment withdrawal;Primary end point(s): The proportion of patients in the randomized withdrawal population who do not experience a flare during the randomized withdrawal retreatment period;Timepoint(s) of evaluation of this end point: Week 64

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Week 104;Secondary end point(s): -Change in modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS score) -The proportion of patients in the randomized withdrawal population who do not experience a flare during the randomized withdrawal-retreatment period -Time to flare during the randomized withdrawal-retreatment period -Time to flare during the randomized withdrawal-retreatment period	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Week 104;Secondary end point(s): -Change in modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS score) -The proportion of patients in the randomized withdrawal population who do not experience a flare during the randomized withdrawal-retreatment period -Time to flare during the randomized withdrawal-retreatment period -Time to flare during the randomized withdrawal-retreatment period

—

Countries

Argentina, Austria, Brazil, Canada, Czech Republic, Finland, France, Germany, Hungary, Israel, Italy, Japan, Korea, Democratic People's Republic of, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russian Federation, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactClinical Operations

Lilly

alonsoaj@lilly.com34916635327

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026