A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE-BRAVE I)

Lilly

Status and phase: Terminated; Phase 3

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Placebo; Drug: Baricitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03616912

I4V-MC-JAHZ (Other Identifier)

16676

2017-005026-37 (EudraCT Number)

Details and patient eligibility

About

The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).

Enrollment: 830 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a clinical diagnosis of SLE at least 24 weeks prior to screening.

• Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization.

• Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening.

• Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 during screening.

• Have a clinical SLEDAI-2K score ≥4 at randomization.

• Have at least 1 British Isles Lupus Assessment Group (BILAG) A score or 2 BILAG B scores during screening.

• Are receiving at least one of the following standard of care medications for SLE:

  • A single antimalarial at a stable dose for at least 8 weeks prior to screening
  • A single immunosuppressant at a stable dose for at least 8 weeks prior to screening
  • An oral corticosteroid, initiated at least 4 weeks prior to screening, at a stable dose ≤40 milligrams/day prednisone (or equivalent) for at least 2 weeks prior to screening. If the participant is not receiving an antimalarial or immunosuppressant, the dose of corticosteroid must be ≥7.5 milligrams/day prednisone (or equivalent)

Exclusion criteria

• Have severe active lupus nephritis.
• Have active 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.
• Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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830 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received two placebo tablets: one matching baricitinib 4 milligram (mg) and one matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.

Treatment:

Drug: Placebo

2 mg Baricitinib

Experimental group

Description:

Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.

Treatment:

Drug: Baricitinib

Drug: Placebo

4 mg Baricitinib

Experimental group

Description:

Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.

Treatment:

Drug: Baricitinib

Drug: Placebo

Placebo Maximum Extended Enrollment (MEE)

Placebo Comparator group

Description:

Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.

Treatment:

Drug: Placebo

2 mg Baricitinib (MEE)

Experimental group

Description:

Participants received one Baricitinib 2 mg tablet and 1 placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.

Treatment:

Drug: Baricitinib

Drug: Placebo

4 mg Baricitinib (MEE)

Experimental group

Description:

Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.

Treatment:

Drug: Baricitinib

Drug: Placebo