A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus

Phase 3

Active, not recruiting

Conditions: Systemic lupus erythematosus withorgan or system involvement,

Registration Number: CTRI/2019/04/018378

Lead Sponsor: Eli Lilly and Company

Brief Summary: 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 750

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 grater than or equal to 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 grater than or equal to 6 during screening.
Have a clinical SLEDAI-2K score grater than or equal to 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.
A single antimalarial at a stable dose for at least 8 weeks prior to screening b.
A single immunosuppressant at a stable dose for at least 8 weeks prior to screening c.
An oral corticosteroid, initiated at least 4 weeks prior to screening, at a stable dose less than or equal to 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 grater than or equal to 7.5 milligrams/day prednisone (or equivalent).

Exclusion Criteria

Have severe active lupus nephritis.
Have active central nervous system lupus.
Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, haematological, 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of baricitinib 4 mg QD and background standard of care therapy compared with placebo and background standard of care therapy on SLE disease activity.	Proportion of patients achieving an SRI 4 response at Week 52, defined as: \| - Reduction of grater than or equal to 4 points from baseline in SLEDAI 2K score; and \| - No new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity score; and \| - No worsening (defined as an increase of grater than or equal to 0.3 points [10 mm] from baseline) in the Physicianâ€™s Global Assessment of Disease Activity.

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of baricitinib 4 mg QD compared to placebo on SLE flares.	- Time to first severe flare over 52 weeks.
To evaluate the corticosteroid sparing effect of baricitinib 2 mg QD compared to placebo.	- Proportion of patients receiving 7.5 mg prednisone (or equivalent) at baseline able to decrease dose by grater than or equal to 25% to a prednisone equivalent dose of less than or equal to 7.5 mg/day maintained between Week 40 and Week 52.
To evaluate the effect of baricitinib 2 mg QD compared to placebo on SLE disease activity.	- Proportion of patients achieving an SRI 4 response at Week 52.
To evaluate the corticosteroid sparing effect of baricitinib 4 mg QD compared to placebo.	- Proportion of patients receiving 7.5 mg prednisone (or equivalent) at baseline able to decrease dose by grater than equal to 25% to a prednisone equivalent dose of less than or equal to 7.5 mg/day maintained between Week 40 and Week 52.
To evaluate the effect of baricitinib 4 mg QD compared to placebo on patient reported outcomes (PROs).	- Change from baseline in Worst Pain NRS at Week 52.
To evaluate the effect of baricitinib 2 mg QD compared to placebo on SLE flares.	- Time to first severe flare over 52 weeks.
To evaluate the effect of baricitinib 2 mg QD compared to placebo on patient reported outcomes (PROs).	- Change from baseline in Worst Pain NRS at Week 52.
To evaluate the effect of baricitinib 4 mg QD compared to placebo on SLE disease activity.	- Proportion of patients achieving an SRI 4 response at Week 24.

Trial Locations

Locations (15): Care Institute of Medical Science CIMS Hospital
🇮🇳
Ahmadabad, GUJARAT, India
ChanRe Rheumatology & Immunology Center & Research
🇮🇳
Bangalore, KARNATAKA, India
Fortis Escorts Hospital
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Jaipur, RAJASTHAN, India
Jasleen Hospital
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Nagpur, MAHARASHTRA, India
Kasturba Medical College and Hospital
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Udupi, KARNATAKA, India
Krishna Institute of Medical Sciences ( KIMS Hospital )
🇮🇳
Hyderabad, TELANGANA, India
Nirmal Hospitals Pvt. Ltd
🇮🇳
Surat, GUJARAT, India
Panchshil Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Post Graduate Institute of Medical Education and Research (PGIMER)
🇮🇳
Chandigarh, CHANDIGARH, India
Shree Giriraj Multispeciality Hospital
🇮🇳
Rajkot, GUJARAT, India
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Care Institute of Medical Science CIMS Hospital
🇮🇳Ahmadabad, GUJARAT, India
Dr Reena Sharma
Principal investigator
919978662400
reena141@gmail.com