Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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21 March 2022 |
Main ID: |
EUCTR2016-002634-69-ES |
Date of registration:
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18/11/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Phase 3, multicenter, long-term extension study of 104 weeks in patients with axial spondyloarthritis
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Scientific title:
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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:
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31/01/2017 |
Target sample size:
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750 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002634-69 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Austria
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Brazil
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Canada
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Czech Republic
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Finland
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France
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Germany
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Hungary
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Israel
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Italy
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Japan
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Korea, Democratic People's Republic of
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Mexico
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Netherlands
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Poland
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Puerto Rico
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Romania
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Russian Federation
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Spain
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Taiwan
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Operations
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Address:
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Avda de la Industria nº 30
28108
Alcobendas (Madrid)
Spain |
Telephone:
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34916635327 |
Email:
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alonsoaj@lilly.com |
Affiliation:
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Lilly |
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Name:
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Clinical Operations
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Address:
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Avda de la Industria nº 30
28108
Alcobendas (Madrid)
Spain |
Telephone:
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34916635327 |
Email:
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alonsoaj@lilly.com |
Affiliation:
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Lilly |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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Axial Spondyloarthritis MedDRA version: 19.0
Level: LLT
Classification code 10041672
Term: Spondylitis ankylosing
System Organ Class: 100000004859
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Intervention(s)
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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
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Primary Outcome(s)
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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
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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
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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
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Timepoint(s) of evaluation of this end point: Week 64
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Week 104
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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
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Secondary ID(s)
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I1F-MC-RHBY
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Source(s) of Monetary Support
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Eli Lilly and Company
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Ethics review
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Status: Approved
Approval date: 25/01/2017
Contact:
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