Clinical Trials List
Protocol NumberI4V-MC-JAHH
NCT Number(ClinicalTrials.gov Identfier)NCT02708095
2016-03-25 - 2019-03-24
Phase II
Terminated4
ICD-10M32.9
Systemic lupus erythematosus, unspecified
ICD-9710.0
Systemic lupus erythematosus
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)
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Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
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Sponsor
Eli Lilly and Company
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Po-Hao Huang 風濕免疫科
- 黃建中 風濕免疫科
- Chung-Ming Huang 風濕免疫科
- 洪偉哲 風濕免疫科
- Jiunn-Horng Chen 風濕免疫科
- 蔡嘉哲 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- CHENG-HAN WU 風濕免疫科
- KO-JEN LI 風濕免疫科
- 郭佑民 風濕免疫科
- CHIEH-YU SHEN 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Systemic Lupus Erythematosus (SLE)
Objectives
主要
針對併用 24 週標準療法的 SLE 病患，評估每日一
次(QD) 4-mg 或每日一次 2-mg baricitinib 相較於安
慰劑，對於緩解 SLE 關節炎和/或皮疹的效果。
次要
1.針對併用 24 週標準療法的 SLE 病患，評估每日一
次(QD) 4-mg 或每日一次 2-mg baricitinib 相較於安
慰劑對於整體 SLE 疾病活動性的效果。
2.針對併用 24 週標準療法的 SLE 病患，評估每日一
次(QD) 4-mg 或每日一次 2-mg baricitinib 相較於安
慰劑對於病患疾病活動性整體評估的效果。
3.針對併用 24 週標準療法的 SLE 病患，探討每日一
次(QD) 4-mg 或每日一次 2-mg baricitinib 的藥物動
力學(pharmacokinetics，PK)。
Test Drug
Baricitinib (LY3009104)
Active Ingredient
Baricitinib (LY3009104)
Dosage Form
tablet
Dosage
2 , 4
Endpoints
Primary Outcome Measures :
1. Percentage of Participants Who Achieve Remission of Arthritis and/or Rash Defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) [ Time Frame: Week 24 ]
Participants were defined as responder as follows using SLEDAI-2K definitions of arthritis and rash. If only arthritis is present at baseline, then arthritis must be absent at Week 24 to meet the primary endpoint. If only rash is present at baseline, then rash must be absent at Week 24 to meet the primary endpoint. If both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24.
Secondary Outcome Measures :
1. Percentage of Participants Who Achieve SLE Responder Index 4 (SRI-4) Response [ Time Frame: Week 24 ]
SRI-4 response is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores; and 3) no worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in Physician's Global Assessment of Disease Activity. The SRI-4 is a composite index used to assess disease activity in SLE. SLEDAI-2K assessment consists of 24 items with total score of 0 to 105, with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe).
2. Change From Baseline in SLEDAI-2K Score [ Time Frame: Baseline, Week 24 ]
SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, region, baseline disease activity (SLEDAI-2K <10, >=10), baseline anti-dsDNA status (positive, negative), treatment, time, treatment*time (type III sum of squares).
3. Change From Baseline in Patient's Global Assessment of Disease Activity [ Time Frame: Baseline, Week 24 ]
The Patient's Global Assessment of Disease Activity is a single-item, patient reported scale developed for the assessment of the patient's overall rating of their disease activity due to SLE. The scale measures disease activity through a 5 point Likert scale ranging from 0 ("No disease activity") to 4 ("Severe disease activity") at its worst over the past 7 days. LS mean was determined by MMRM model with baseline of response, region, baseline disease activity (SLEDAI-2K <10, >=10), baseline anti-dsDNA status (positive, negative), treatment, time, treatment*time (type III sum of squares).
4. Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss) [ Time Frame: Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose ]
Plasma samples for pharmacokinetic (PK) analysis were obtained in week 0, week 4, week 8, week 16 and 24. AUC takes all time points post dose into account and one value is reported.
5. Population Pharmacokinetics (PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) [ Time Frame: Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose ]
Plasma samples for pharmacokinetic (PK) analysis were obtained in week 0, week 4, week 8, week 16 and 24. Cmax takes all time points post dose into account and one value is reported.
1. Percentage of Participants Who Achieve Remission of Arthritis and/or Rash Defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) [ Time Frame: Week 24 ]
Participants were defined as responder as follows using SLEDAI-2K definitions of arthritis and rash. If only arthritis is present at baseline, then arthritis must be absent at Week 24 to meet the primary endpoint. If only rash is present at baseline, then rash must be absent at Week 24 to meet the primary endpoint. If both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24.
Secondary Outcome Measures :
1. Percentage of Participants Who Achieve SLE Responder Index 4 (SRI-4) Response [ Time Frame: Week 24 ]
SRI-4 response is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores; and 3) no worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in Physician's Global Assessment of Disease Activity. The SRI-4 is a composite index used to assess disease activity in SLE. SLEDAI-2K assessment consists of 24 items with total score of 0 to 105, with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe).
2. Change From Baseline in SLEDAI-2K Score [ Time Frame: Baseline, Week 24 ]
SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, region, baseline disease activity (SLEDAI-2K <10, >=10), baseline anti-dsDNA status (positive, negative), treatment, time, treatment*time (type III sum of squares).
3. Change From Baseline in Patient's Global Assessment of Disease Activity [ Time Frame: Baseline, Week 24 ]
The Patient's Global Assessment of Disease Activity is a single-item, patient reported scale developed for the assessment of the patient's overall rating of their disease activity due to SLE. The scale measures disease activity through a 5 point Likert scale ranging from 0 ("No disease activity") to 4 ("Severe disease activity") at its worst over the past 7 days. LS mean was determined by MMRM model with baseline of response, region, baseline disease activity (SLEDAI-2K <10, >=10), baseline anti-dsDNA status (positive, negative), treatment, time, treatment*time (type III sum of squares).
4. Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss) [ Time Frame: Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose ]
Plasma samples for pharmacokinetic (PK) analysis were obtained in week 0, week 4, week 8, week 16 and 24. AUC takes all time points post dose into account and one value is reported.
5. Population Pharmacokinetics (PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) [ Time Frame: Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose ]
Plasma samples for pharmacokinetic (PK) analysis were obtained in week 0, week 4, week 8, week 16 and 24. Cmax takes all time points post dose into account and one value is reported.
Inclution 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.
• 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
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.
• 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.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
300 participants
