A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01205438
• Date of registration: 17/09/2010
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• 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)
• Date of first enrolment: January 2011
• Target sample size: 1124
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01205438
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Brazil, Canada, Ecuador, France, Hungary, India, Israel, Latvia, Malaysia, Mexico, New Zealand, Romania, Russian Federation, Serbia, South Africa, Spain, Taiwan, Tunisia, United Kingdom, United States

Contacts

• Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT -5 hours, EST)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

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.)

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Autoimmune Disease

Connective Tissue Disease

Systemic Lupus Erythematosus

Intervention(s)

Drug: Placebo every 2 weeks

Drug: LY2127399

Drug: Placebo every 4 weeks

Primary Outcome(s)

Percentage of Participants Achieving an SLE Responder Index Response at Week 52 [Time Frame: 52 weeks]

Secondary Outcome(s)

Change From Baseline to 52 Week Endpoint in Physician's Global Assessment (PGA) [Time Frame: Baseline, 52 weeks]

Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores [Time Frame: Baseline, 52 weeks]

Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares [Time Frame: Baseline through 52 weeks]

Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score [Time Frame: Baseline, 52 weeks]

Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score [Time Frame: Baseline, 52 weeks]

Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level [Time Frame: Baseline, 52 weeks]

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 [Time Frame: 52 weeks]

Percentage of Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52 [Time Frame: 52 weeks]

Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline [Time Frame: Baseline through 52 weeks]

Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks [Time Frame: 52 weeks]

Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks [Time Frame: 52 weeks]

Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores [Time Frame: Baseline, 52 weeks]

Time to First Severe SLE Flare (SFI) [Time Frame: Baseline through 52 weeks]

Secondary ID(s)

13653

H9B-MC-BCDT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/06/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01205438