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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01205438




Registration number
NCT01205438
Ethics application status
Date submitted
17/09/2010
Date registered
20/09/2010
Date last updated
17/07/2018

Titles & IDs
Public title
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
Scientific title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients With Systemic Lupus Erythematosus (SLE)
Secondary ID [1] 0 0
H9B-MC-BCDT
Secondary ID [2] 0 0
13653
Universal Trial Number (UTN)
Trial acronym
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 every 2 weeks
Treatment: Drugs - Placebo every 4 weeks

Experimental: LY2127399 every 2 weeks -

Experimental: LY2127399 every 4 weeks - During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.

Placebo comparator: Placebo -


Treatment: Drugs: LY2127399
120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug

Treatment: Drugs: Placebo every 2 weeks
Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.

Treatment: Drugs: Placebo every 4 weeks
Administered via subcutaneous injection for 52 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving an SLE Responder Index Response at Week 52
Timepoint [1] 0 0
52 weeks
Secondary outcome [1] 0 0
Percentage of Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52
Timepoint [1] 0 0
52 weeks
Secondary outcome [2] 0 0
Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level
Timepoint [2] 0 0
Baseline, 52 weeks
Secondary outcome [3] 0 0
Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score
Timepoint [3] 0 0
Baseline, 52 weeks
Secondary outcome [4] 0 0
Time to First Severe SLE Flare (SFI)
Timepoint [4] 0 0
Baseline through 52 weeks
Secondary outcome [5] 0 0
Change From Baseline to 52 Week Endpoint in Physician's Global Assessment (PGA)
Timepoint [5] 0 0
Baseline, 52 weeks
Secondary outcome [6] 0 0
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores
Timepoint [6] 0 0
Baseline, 52 weeks
Secondary outcome [7] 0 0
Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks
Timepoint [7] 0 0
52 weeks
Secondary outcome [8] 0 0
Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores
Timepoint [8] 0 0
Baseline, 52 weeks
Secondary outcome [9] 0 0
Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares
Timepoint [9] 0 0
Baseline through 52 weeks
Secondary outcome [10] 0 0
Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks
Timepoint [10] 0 0
52 weeks
Secondary outcome [11] 0 0
Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score
Timepoint [11] 0 0
Baseline, 52 weeks
Secondary outcome [12] 0 0
Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline
Timepoint [12] 0 0
Baseline through 52 weeks
Secondary outcome [13] 0 0
Percentage of Participants Achieving a Response as Measured by Modified SRI With No BILAG A or No More Than 1 BILAG B Organ Domain Flares at 52 Weeks
Timepoint [13] 0 0
52 weeks

Eligibility
Key inclusion criteria
* Clinical diagnosis of SLE as defined by American College of Rheumatology (ACR) criteria
* Have positive antinuclear antibodies (ANA)
* Agree not to become pregnant throughout the course of the trial
* Have a screening SELENA-SLEDAI score =6. (The participant must be actively exhibiting all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have active severe Lupus kidney disease
* Have active Central Nervous System or peripheral neurologic disease
* Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
* Have active or recent infection within 30 days of screening
* Have had a serious infection within 90 days of randomization
* Have evidence or test positive for Hepatitis B
* Have Hepatitis C
* Are human immunodeficiency virus (HIV) positive
* Have evidence of active or latent tuberculosis (TB)
* Presence of significant laboratory abnormalities at screening
* Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
* Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
* Have changed your dose of antimalarial drug in the past 30 days
* Have changed your dose of immunosuppressive drug in the past 90 days
* Have previously received rituximab

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
1124
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - St Leonards
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Cairns
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Maroochydore
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Clayton
Recruitment hospital [5] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Heidelberg
Recruitment hospital [6] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Malvern East
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg
Recruitment postcode(s) [6] 0 0
3145 - Malvern East
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM 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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01205438