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Clinical Trials/EUCTR2015-004404-35-RO
EUCTR2015-004404-35-ROActive, not recruitingPhase 1

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)

Eli Lilly and Company0 sites314 target enrollmentStarted: June 22, 2016Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
314
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •[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

Exclusion Criteria

  • •[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.

Investigators

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