Phase 2
N=314
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT02708095 ↗Enrolled (actual)
314
Serious AEs
8.3%
Results posted
Nov 2018
Primary outcome: Primary: Percentage of Participants Who Achieve Remission of Arthritis and/or Rash Defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) — 53.3; 58.1; 67.3 Percentage of Participants — p=0.392
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Baricitinib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieve Remission of Arthritis and/or Rash Defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) |
53.3; 58.1; 67.3 | 0.392 |
| SECONDARY Percentage of Participants Who Achieve SLE Responder Index 4 (SRI-4) Response |
47.6; 51.4; 64.4 | 0.440 |
| SECONDARY Change From Baseline in SLEDAI-2K Score |
-3.82; -4.07; -4.39 | 0.600 |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity |
-0.67; -0.83; -1.00 | 0.285 |
| SECONDARY Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss) |
265; 569 | — |
| SECONDARY Population Pharmacokinetics (PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) |
29.0; 59.2 | — |
Summary
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as baricitinib in participants with systemic lupus erythematosus.
Eligibility Criteria
Inclusion Criteria
- Have received a diagnosis of SLE at least 24 weeks prior to screening, meeting the American College of Rheumatology (ACR) 1982 revised criteria OR the 2012 Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria.
- Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA) as assessed by a central laboratory at screening.
- Have a SLEDAI-2K score ≥4 based on clinical symptoms (not including lab values) at randomization.
- Have active arthritis and/or active rash as defined by the SLEDAI-2K at randomization.
Exclusion Criteria
- Have active severe lupus nephritis.
- Have active severe central nervous system (CNS) lupus.
- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
- Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
- Are currently receiving oral corticosteroids at doses >20-milligrams per day of prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks of planned randomization.
- Have started treatment with or adjusted the dose of nonsteroidal anti-inflammatory drugs (NSAIDs) (for which the NSAID use is intended for treatment of signs and symptoms of SLE) within 4 weeks of planned randomization.
- Have started treatment with or adjusted the dose of an antimalarial within 12 weeks of planned randomization.
- Have started treatment with or adjusted the dose of an immunosuppressant within 12 weeks of planned randomization.
- Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.
Data sourced from ClinicalTrials.gov (NCT02708095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.