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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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United States of America
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Dorset
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Greater London
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London

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 efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in participants with active SLE.
Trial website
https://clinicaltrials.gov/study/NCT01205438
Trial related presentations / publications
Toro-Dominguez D, Martorell-Marugan J, Martinez-Bueno M, Lopez-Dominguez R, Carnero-Montoro E, Barturen G, Goldman D, Petri M, Carmona-Saez P, Alarcon-Riquelme ME. Scoring personalized molecular portraits identify Systemic Lupus Erythematosus subtypes and predict individualized drug responses, symptomatology and disease progression. Brief Bioinform. 2022 Sep 20;23(5):bbac332. doi: 10.1093/bib/bbac332.
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Li Y, Higgs RE, Hoffman RW, Dow ER, Liu X, Petri M, Wallace DJ, Dorner T, Eastwood BJ, Miller BB, Liu Y. A Bayesian gene network reveals insight into the JAK-STAT pathway in systemic lupus erythematosus. PLoS One. 2019 Dec 2;14(12):e0225651. doi: 10.1371/journal.pone.0225651. eCollection 2019.
Kalunian KC, Urowitz MB, Isenberg D, Merrill JT, Petri M, Furie RA, Morgan-Cox MA, Taha R, Watts S, Silk M, Linnik MD. Clinical trial parameters that influence outcomes in lupus trials that use the systemic lupus erythematosus responder index. Rheumatology (Oxford). 2018 Jan 1;57(1):125-133. doi: 10.1093/rheumatology/kex368.
Rovin BH, Dooley MA, Radhakrishnan J, Ginzler EM, Forrester TD, Anderson PW. The impact of tabalumab on the kidney in systemic lupus erythematosus: results from two phase 3 randomized, clinical trials. Lupus. 2016 Dec;25(14):1597-1601. doi: 10.1177/0961203316650734. Epub 2016 May 24.
Hoffman RW, Merrill JT, Alarcon-Riquelme MM, Petri M, Dow ER, Nantz E, Nisenbaum LK, Schroeder KM, Komocsar WJ, Perumal NB, Linnik MD, Airey DC, Liu Y, Rocha GV, Higgs RE. Gene Expression and Pharmacodynamic Changes in 1,760 Systemic Lupus Erythematosus Patients From Two Phase III Trials of BAFF Blockade With Tabalumab. Arthritis Rheumatol. 2017 Mar;69(3):643-654. doi: 10.1002/art.39950.
Merrill JT, van Vollenhoven RF, Buyon JP, Furie RA, Stohl W, Morgan-Cox M, Dickson C, Anderson PW, Lee C, Berclaz PY, Dorner T. Efficacy and safety of subcutaneous tabalumab, a monoclonal antibody to B-cell activating factor, in patients with systemic lupus erythematosus: results from ILLUMINATE-2, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016 Feb;75(2):332-40. doi: 10.1136/annrheumdis-2015-207654. Epub 2015 Aug 20.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01205438