Trial Review

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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
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)
Secondary ID [1] 0 0
H9B-MC-BCDX
Secondary ID [2] 0 0
13811
Universal Trial Number (UTN)
Trial acronym
Illuminate-X
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Connective Tissue Disease 0 0
Autoimmune Disease 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
Baseline through 4 years
Secondary outcome [1] 0 0
Proportion of Participants With a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Proportion of Participants With a Reduction in Steroid Dose
Timepoint [2] 0 0
Baseline through 4 years
Secondary outcome [3] 0 0
Change in SLE Disease Activity Index
Timepoint [3] 0 0
Baseline, 4 years
Secondary outcome [4] 0 0
Occurrence of New Severe SLE Flares
Timepoint [4] 0 0
Baseline through 4 years
Secondary outcome [5] 0 0
Proportion of Participants With Improvement in Lupus Quality of Life
Timepoint [5] 0 0
4 years
Secondary outcome [6] 0 0
Change in Anti-double-stranded Deoxyribonucleic Acid Level
Timepoint [6] 0 0
Baseline, 4 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
1518
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01488708
Trial related presentations / publications
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

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
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01488708