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

• Register: EUCTR
• Last refreshed on: 7 June 2021
• Main ID: EUCTR2016-002634-69-HU
• Date of registration: 22/11/2016
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: Phase 3, multicenter, long-term extension study of 104 weeks in patients with axial spondyloarthritis
• Scientific title: 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
• Date of first enrolment: 19/01/2017
• Target sample size: 750
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002634-69
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 6
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

Key inclusion & exclusion 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:
-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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

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
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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

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

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

Timepoint(s) of evaluation of this end point: Week 64

Secondary Outcome(s)

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

Timepoint(s) of evaluation of this end point: Week 104

Secondary ID(s)

I1F-MC-RHBY

2016-002634-69-ES

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 11/01/2017
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