Clinical Trials List
Protocol NumberI1F-MC-RHBY
NCT Number(ClinicalTrials.gov Identfier)NCT03129100
Completed
2017-05-09 - 2021-05-27
Phase III
Terminated5
ICD-10M48.8X9
Other specified spondylopathies, site unspecified
ICD-9720.0
Ankylosing spondylitis
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
-
Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
-
Sponsor
Eli Lilly and Company
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Po-Hao Huang 風濕免疫科
- 洪偉哲 風濕免疫科
- 黃建中 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- CHENG-HAN WU Division of General Internal Medicine
- CHIH-WEI YU Division of Radiology
- KO-JEN LI Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Axial Spondyloarthritis
Objectives
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.
Test Drug
Ixekizumab (LY2439821)
Active Ingredient
Ixekizumab (LY2439821)
Dosage Form
injection
Dosage
80
Endpoints
The proportion of patients in the randomized-withdrawal population who do not experience a flare during the randomized
withdrawal-retreatment period
withdrawal-retreatment period
Inclution Criteria
Inclusion Criteria
The study population for Study RHBY will include patients from any of the originating studies
(RHBV, RHBW, or RHBX), and will therefore include patients with rad-axSpA and patients
with nonrad-axSpA, with or without prior use of TNF inhibitors.
For most patients, Week 52 of the originating study (RHBV, RHBW, or RHBX) will coincide
with Week 0 (Visit 1) for Study RHBY. Study investigator(s) will review patient data from
Week 52 in the respective originating study to determine if the patient meets all inclusion and
none of the exclusion criteria to qualify for participation in Study RHBY. If, at Week 52 in the
originating study, a patient is not able to enter Study RHBY (for example, due to unresolved
safety concerns), investigational product will be temporarily interrupted and the patient will be
evaluated in the originating study for up to 12 weeks beyond Week 52 (that is, Visit 802 in the
originating study) to determine whether treatment with investigational product can resume. If, in
the opinion of the investigator, restarting ixekizumab does not pose an unacceptable risk, the
patient can begin participation in Study RHBY (Visit 1 [Week 0]).
Patients are eligible to be included in the study only if they meet the following 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.
If a male patient, patient agrees to use a reliable method of birth control
during the study and for at least 12 weeks following the last dose of
investigational product, whichever is longer. If a female patient, patient is
a woman of childbearing potential who tests negative for pregnancy and
agrees to use a reliable method of birth control or remain abstinent during
the study and for at least 12 weeks following the last dose of
investigational product, whichever is longer. Methods of birth control
include, but are not limited to, condoms with spermicide, male
sterilization, oral contraceptives, contraceptive patch, injectable or
implantable contraceptives, intrauterine device, vaginal ring, or diaphragm
with contraceptive gel.
(Note: Where required by regulation, a highly effective method of birth
control is required. A highly effective method of birth control is defined
as one that results in a low failure rate [that is, <1% per year] when used
consistently and correctly, such as male sterilization, oral contraceptives,
contraceptive patch, injectable or implantable contraceptives, intrauterine
device, or vaginal ring).
OR
If a female patient is a woman of nonchildbearing potential she is not
required to use any method of birth control. Nonchildbearing potential is
defined as:
Women who have had surgical sterilization (hysterectomy, bilateral
oophorectomy, or tubal ligation).
- or -
Women who are ≥60 years of age.
- or -
Women ≥40 and <60 years of age who have had a cessation of menses for
≥12 months and a follicle stimulating hormone (FSH) test confirming
nonchildbearing potential (≥40 mIU/mL or ≥40 IU/L).
[3.] Have given written informed consent approved by Lilly or its designee, and
the Investigational Review Board (IRB)/Ethical Review Board (ERB)
governing the site.
The study population for Study RHBY will include patients from any of the originating studies
(RHBV, RHBW, or RHBX), and will therefore include patients with rad-axSpA and patients
with nonrad-axSpA, with or without prior use of TNF inhibitors.
For most patients, Week 52 of the originating study (RHBV, RHBW, or RHBX) will coincide
with Week 0 (Visit 1) for Study RHBY. Study investigator(s) will review patient data from
Week 52 in the respective originating study to determine if the patient meets all inclusion and
none of the exclusion criteria to qualify for participation in Study RHBY. If, at Week 52 in the
originating study, a patient is not able to enter Study RHBY (for example, due to unresolved
safety concerns), investigational product will be temporarily interrupted and the patient will be
evaluated in the originating study for up to 12 weeks beyond Week 52 (that is, Visit 802 in the
originating study) to determine whether treatment with investigational product can resume. If, in
the opinion of the investigator, restarting ixekizumab does not pose an unacceptable risk, the
patient can begin participation in Study RHBY (Visit 1 [Week 0]).
Patients are eligible to be included in the study only if they meet the following 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.
If a male patient, patient agrees to use a reliable method of birth control
during the study and for at least 12 weeks following the last dose of
investigational product, whichever is longer. If a female patient, patient is
a woman of childbearing potential who tests negative for pregnancy and
agrees to use a reliable method of birth control or remain abstinent during
the study and for at least 12 weeks following the last dose of
investigational product, whichever is longer. Methods of birth control
include, but are not limited to, condoms with spermicide, male
sterilization, oral contraceptives, contraceptive patch, injectable or
implantable contraceptives, intrauterine device, vaginal ring, or diaphragm
with contraceptive gel.
(Note: Where required by regulation, a highly effective method of birth
control is required. A highly effective method of birth control is defined
as one that results in a low failure rate [that is, <1% per year] when used
consistently and correctly, such as male sterilization, oral contraceptives,
contraceptive patch, injectable or implantable contraceptives, intrauterine
device, or vaginal ring).
OR
If a female patient is a woman of nonchildbearing potential she is not
required to use any method of birth control. Nonchildbearing potential is
defined as:
Women who have had surgical sterilization (hysterectomy, bilateral
oophorectomy, or tubal ligation).
- or -
Women who are ≥60 years of age.
- or -
Women ≥40 and <60 years of age who have had a cessation of menses for
≥12 months and a follicle stimulating hormone (FSH) test confirming
nonchildbearing potential (≥40 mIU/mL or ≥40 IU/L).
[3.] Have given written informed consent approved by Lilly or its designee, and
the Investigational Review Board (IRB)/Ethical Review Board (ERB)
governing the site.
Exclusion Criteria
Exclusion Criteria
Patients will be excluded from study enrollment if they meet any of the following criteria:
[4.] Have significant uncontrolled cerebro-cardiovascular (for example,
myocardial infarction [MI],unstable angina, unstable arterial hypertension,
severe heart failure, or cerebrovascular accident), 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.
[5.] Have a known hypersensitivity to ixekizumab or any component of this
investigational product.
[6.] Had investigational product permanently discontinued during a previous
ixekizumab study.
[7.] 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.
[8.] 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
[9.] 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.
Patients will be excluded from study enrollment if they meet any of the following criteria:
[4.] Have significant uncontrolled cerebro-cardiovascular (for example,
myocardial infarction [MI],unstable angina, unstable arterial hypertension,
severe heart failure, or cerebrovascular accident), 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.
[5.] Have a known hypersensitivity to ixekizumab or any component of this
investigational product.
[6.] Had investigational product permanently discontinued during a previous
ixekizumab study.
[7.] 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.
[8.] 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
[9.] 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.
The Estimated Number of Participants
-
Taiwan
60 participants
-
Global
773 participants
