The main purpose of this study is to assess the efficacy and safety of LY3361237 in participants with at least moderately active systemic lupus erythematosus (SLE). Study will last up to 34 weeks and may include up to 15 visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
85
Percentage of Participants With Arthritis and/or Rash at Baseline Who Achieve Remission of Arthritis and/or Rash
Remission of arthritis and/or rash is defined by the following: if only arthritis is present at baseline, then the primary endpoint is met if arthritis is absent at Week 24; if only rash is present at baseline, then the primary endpoint is met if rash is absent at Week 24; if both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24.
Time frame: Week 24
Percentage of Participants Who Achieve Systemic Lupus Erythematosus Disease Activity Index-4 (SLEDAI-4) Response
Percentage of participants who achieved SLEDAI-4 response was assessed. A SLEDAI-4 response is defined as a ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score from baseline. The SLEDAI-2K score range is from a minimum of 0 to a maximum of 105 (higher scores represent higher disease activity).
Time frame: Week 24
Percentage of Participants Who Achieve Systemic Lupus Erythematosus Responder Index-4 (SRI-4 Response)
Percentage of participants who achieved SRI-4 response was assessed. SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.
Time frame: Week 24
Pharmacokinetics (PK): Steady-state Trough Serum Concentration of LY3361237 at Week 24
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Arizona Arthritis & Rheumatology Associates, P. C.
Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Associates
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Research - Sun City
Sun City, Arizona, United States
Newport Huntington Med Grp
Huntington Beach, California, United States
Desert Medical Advances
Rancho Mirage, California, United States
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, United States
Ezy Medical Research
Miami, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Atlanta Research Center for Rheumatology
Marietta, Georgia, United States
Qualmedica Research, LLC
Evansville, Indiana, United States
...and 40 more locations
PK: Steady-state trough serum concentration of LY3361237 at Week 24 was assessed.
Time frame: Week 24