Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01488708
Registration number
NCT01488708
Ethics application status
Date submitted
6/12/2011
Date registered
8/12/2011
Date last updated
17/05/2018
Titles & IDs
Public title
On Open-Label Study in Participants With Systemic Lupus Erythematosus
Query!
Scientific title
A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE) (Illuminate-X)
Query!
Secondary ID [1]
0
0
H9B-MC-BCDX
Query!
Secondary ID [2]
0
0
13811
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Illuminate-X
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus
0
0
Query!
Connective Tissue Disease
0
0
Query!
Autoimmune Disease
0
0
Query!
Condition category
Condition code
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Autoimmune diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - LY2127399
Treatment: Drugs - Placebo
Experimental: LY 2127399 Q2W - If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.
Experimental: LY2127399 Q4W - If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.
Treatment: Drugs: LY2127399
120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.
Treatment: Drugs: Placebo
Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With Adverse Events (AEs)
Query!
Assessment method [1]
0
0
A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Query!
Timepoint [1]
0
0
Baseline through 4 years
Query!
Secondary outcome [1]
0
0
Proportion of Participants With a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Week 48
Query!
Secondary outcome [2]
0
0
Proportion of Participants With a Reduction in Steroid Dose
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Baseline through 4 years
Query!
Secondary outcome [3]
0
0
Change in SLE Disease Activity Index
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Baseline, 4 years
Query!
Secondary outcome [4]
0
0
Occurrence of New Severe SLE Flares
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Baseline through 4 years
Query!
Secondary outcome [5]
0
0
Proportion of Participants With Improvement in Lupus Quality of Life
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
4 years
Query!
Secondary outcome [6]
0
0
Change in Anti-double-stranded Deoxyribonucleic Acid Level
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Baseline, 4 years
Query!
Eligibility
Key inclusion criteria
- Have completed 52 weeks of treatment in core studies (NCT01196091) (NCT01205438)
- Given written informed consent
- Test negative for pregnancy at the time of enrollment
- Agree to use a reliable method of birth control
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Unwilling to comply with study procedures
- Any condition that renders the participants unable to understand the nature and scope
and possible consequences of the study
- Any condition that in the opinion of the investigator poses an unacceptable risk to
the participants if study drug would be administered
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/01/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/10/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1518
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Texas
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Eli Lilly and Company
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this SLE study is to evaluate the long-term safety and efficacy of LY2127399
in eligible SLE participants who have completed the core studies (NCT01196091) (NCT01205438).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01488708
Query!
Trial related presentations / publications
Query!
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
Query!
Contacts
Principal investigator
Name
0
0
Call 1-877-CTLILLY(1-877-285-4559 or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT-5 hours, EST
Query!
Address
0
0
Eli Lilly and Company
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01488708
Download to PDF