A study in Lupus
- Conditions
- Patients with Systemic Lupus Erythematosus (SLE)MedDRA version: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-004404-35-RO
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 314
[1] Are at least 18 years of age.
[2] Have a positive ANA (HEp-2 ANA titer =1:80) and/or a positive anti-dsDNA (= 30 IU) as assessed by a central laboratory at screening.
[3] Have a SLEDAI-2K score =4 based on clinical symptoms (not including lab values) at randomization.
[4] Have active arthritis and/or active rash as defined by the SLEDAI-2K at randomization.
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 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
[1] Have active severe lupus nephritis
[2] Have active severe central nervous system (CNS) lupus
[3] 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 unaccepatable risk when taking investigational product or interfere with the interpretation of data.
[4] Have a current or recent (<4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection.
[5] Are currently receiving oral corticosteroids at doses >20-mg per day of prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks of planned randomization.
[6] Have started treatment with or adjusted the dose of NSAIDs (for which the NSAID use is intended for treatment of signs and symptoms of SLE) within 2 weeks of screening or within 4 weeks of planned randomization.
[7] Have started treatment with or adjusted the dose of an antimalarial within 10 weeks of screening or within 12 weeks of planned randomization.
[8] Have started treatment with or adjusted the dose of an immunosuppressant within 10 weeks of screening or within 12 weeks of planned randomization.
[9] Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method