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) - ND

• Register: EUCTR
• Last refreshed on: 14 September 2015
• Main ID: EUCTR2010-022099-29-IT
• Date of registration: 07/02/2011
• Prospective Registration: Yes
• Primary sponsor: ELI LILLY
• Public 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) - ND
• 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) - ND
• Date of first enrolment: 01/06/2011
• Target sample size: 1140
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022099-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: 3 arm study to investigate dosing intervals (2 weeks vs 4 weeks vs placebo) If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, Bulgaria, Germany, Italy

Key inclusion & exclusion criteria

Inclusion criteria:
Main Inclusion Criteria: [1] Are males or females =18 years of age. [2] Have a clinical diagnosis of SLE defined as meeting 4 of the 11 American College of Rheumatology (ACR) criteria. [3] Have a positive ANA (HEp-2 ANA titer =1:80) as assessed by a central laboratory at screening. Patients with a negative ANA test result but positive anti-dsDNA test result at screening will have ANA repeated 1 time during the Screening Period. If the repeat ANA is also negative, the patient will be excluded from the study. [4] Have a screening SELENA-SLEDAI score =6. (The patient must be actively exhibiting all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Main Exclusion Criteria: [5] Have active lupus nephritis as assessed by the investigator or urine protein/creatinine ratio of >200 mg/mmol or estimated creatinine clearance <30 mL/min. If urine protein/creatinine ratio or estimated creatinine clearance are inconsistent with the investigator’s clinical assessment of a patient’s renal function, these tests may be repeated 1 time during the Screening Period. If the repeat tests are also outside the stated values, the patient will be excluded from the study. [6] Have active CNS or peripheral neurologic disease including seizure, psychosis, stroke, cerebritis or isolated CNS vasculitis, myelopathy, Guillain-Barre Syndrome, or other severe neurologic involvement requiring treatment within 90 days prior to screening. Fr the complete list of the esclusion criteria, please refer to the protocol.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus (SLE)
MedDRA version: 9.1 Level: PT Classification code 10042945

Intervention(s)

Product Name: LY2127399
Product Code: LY2127399
Pharmaceutical Form: Solution for injection
Current Sponsor code: LY2127399
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: The primary objective of this study is to demonstrate the efficacy LY2127399 versus placebo, as assessed by the proportion of patients with SLE who achieve a response at 52 weeks (as measured on a composite disease activity index). Please refer to the Protocol for the complete description of the Main objective.

Primary end point(s): Proportion of patients achieving an SLE Responder Index response at week 52.

Secondary Objective: The secondary objectives of the study are as follows: - To demonstrate the corticosteroid sparing effects of LY2127399 compared to placebo over 52 weeks - To demonstrate the effect of LY2127399 on serum markers of SLE including anti-double stranded DNA (antidsDNA) compared to placebo over 52 weeks - To demonstrate the efficacy of LY2127399 on disease activity in patients with SLE compared to placebo over 52 weeks - To demonstrate the efficacy of LY2127399 on reducing time to flare in patients with SLE compared to placebo over 52 weeks - To demonstrate the effect of LY2127399 on fatigue in patients with SLE compared to placebo over 52 weeks - To demonstrate the effect of LY2127399 on quality of life in patients with SLE compared to placebo over 52 weeks. Please refer to the Protocol for the complete description of the secondary objective.

Secondary ID(s)

H9B-MC-BCDS

2010-022099-29-DE