A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01196091
• Date of registration: 03/09/2010
• 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 Participants With Systemic Lupus Erythematosus (SLE)
• Date of first enrolment: December 2010
• Target sample size: 1164
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01196091
• 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

Argentina, Austria, Belarus, Bulgaria, Canada, Chile, Colombia, Croatia, Egypt, Germany, Guatemala, Italy, Japan, Korea, Republic of, Macedonia, The Former Yugoslav Republic of, Peru, Philippines, Poland, Puerto Rico, Singapore, Thailand, Turkey, Ukraine, 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 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

Connective Tissue Disease

Systemic Lupus Erythematosus

Autoimmune Disease

Intervention(s)

Drug: Standard of Care

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 Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score [Time Frame: Baseline, 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]

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

Change From Baseline to 52 Week Endpoint in PGA [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]

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

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

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

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

Secondary ID(s)

H9B-MC -BCDS

13656

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/06/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01196091