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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024069-30 | EudraCT Number |
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To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).
This is a Phase 2b, multinational, multicenter, randomized, double-blind, placebo controlled, parallel group study to evaluate the efficacy and safety of three intravenous (IV) treatment regimens of sifalimumab (200, 600, or 1,200 mg) in adult subjects with chronic moderately-to-severely active SLE with an inadequate response to standard of care (SOC) for SLE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sifalimumab 200 milligram (mg) | Experimental | Sifalimumab 200 milligram (mg) will be administered intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses. |
|
| Sifalimumab 600 mg | Experimental | Sifalimumab 600 mg will be administered intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses. |
|
| Sifalimumab 1,200 mg | Experimental | Sifalimumab 1,200 mg will be administered intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses. |
|
| Placebo | Placebo Comparator | Placebo matching to sifalimumab will be administered intravenously at a fixed dose every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sifalimumab 200 mg | Biological | Sifalimumab 200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) | SRI (4) responder is defined as: 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points (with increased deoxyribonucleic acid [DNA] binding item of SLEDAI-2K score based on the ANA Multi-Lyte® ANA-II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in British Isles Lupus Assessment Group (BILAG-2004) (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline). | Day 365 |
| Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants | SRI (4) responder is defined as: 1) a reduction in baseline SLEDAI-2K disease activity score of >=4 points (with increased DNA binding item of SLEDAI-2K score based on the ANA Multi-Lyte® ANA-II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in BILAG-2004 (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline). | Day 365 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day | Percentage of participants on >=10 mg/day oral corticosteroids (OCS) at baseline who were able to taper it to <=7.5 mg/day by Day 365 were recorded. | Day 365 |
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Inclusion Criteria: - Fulfills at least 4 of American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA) or elevated ds-deoxyribonucleic acid (DNA) or Sm antibody at screening - Disease history of SLE greater than or equal to (>=) 24 weeks at screening - Weight more than (>) 40 kilogram (kg) - Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives - Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment - No evidence of cervical malignancy on PAP within 6 months of randomization - Female subjects must be willing to avoid pregnancy - Negative TB test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization. Exclusion Criteria: - Active severe SLE-driven renal disease or unstable renal disease prior to screening - Active severe or unstable neuropsychiatric SLE - Clinically significant active infection including ongoing and chronic infections - History of human immunodeficiency virus (HIV) - Confirmed Positive tests for Hepatitis B or positive test for hepatitis C - History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes - Herpes Zoster within 3 months of screening - History of cancer other than basal cancer or cervical cancer treated with apparent success >=1 year prior to randomization - Receipt of a biologic agent within 5 half-lives or prior to loss of pharmacodynamic and/or clinical effect (whichever is longer) prior to screening - Live or attenuated vaccine within 4 weeks prior to screening - Subjects with substance abuse - Subjects with significant hematologic abnormalities.
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| Name | Affiliation | Role |
|---|---|---|
| Gabor Illei, MD | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | La Jolla | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27009916 | Background | Khamashta M, Merrill JT, Werth VP, Furie R, Kalunian K, Illei GG, Drappa J, Wang L, Greth W; CD1067 study investigators. Sifalimumab, an anti-interferon-alpha monoclonal antibody, in moderate to severe systemic lupus erythematosus: a randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016 Nov;75(11):1909-1916. doi: 10.1136/annrheumdis-2015-208562. Epub 2016 Mar 23. | |
| 33687069 |
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A total of 834 participants were screened out of which 402 participants did not meet eligibility criteria and were considered screen failures, and 432 participants were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
| FG001 | Sifalimumab 200 Milligram (mg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Sifalimumab 600 mg | Biological | Sifalimumab 600 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses. |
|
|
| Sifalimumab 1,200 mg | Biological | Sifalimumab 1,200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses. |
|
|
| Placebo | Other | IV Placebo every 2 weeks for 4 weeks and then monthly for 44 weeks |
|
| Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction |
The CLASI consists of two scores, the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. The percentage of participants with a CLASI activity score >=10 at baseline who achieved a clinically significant (>=4-point) reduction at Day 365 were reported. |
| Day 365 |
| Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). | Day 365 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of investigational product, for the period extending until the end of participant participation in the study. | Day 1 up to Week 74 |
| Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Laboratory investigations included hematology, serum chemistries and urinalysis parameters. Participants with clinically significant abnormalities in these laboratory investigations recorded as TEAEs were reported. | Day 1 up to Week 61 |
| Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiratory rate. Vital signs abnormalities recorded as TEAEs were reported. | Day 1 up to Week 61 |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs | The 12-lead ECG data were summarized and evaluated. Number of participants with clinically significant abnormal ECG findings as assessed by cardiologist were recorded and reported as TEAEs. | Day 1 up to Week 56 |
| Palm Desert |
| California |
| United States |
| Research Site | San Leandro | California | United States |
| Research Site | Fort Lauderdale | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Stockbridge | Georgia | United States |
| Research Site | Idaho Falls | Idaho | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Lansing | Michigan | United States |
| Research Site | Brooklyn | New York | United States |
| Research Site | Manhasset | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Charlotte | North Carolina | United States |
| Research Site | Raleigh | North Carolina | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Seattle | Washington | United States |
| Research Site | Buenos Aires | Argentina |
| Research Site | Ciudad Autonoma de Buenos Aire | Argentina |
| Research Site | Ciudad de Buenos Aires | Argentina |
| Research Site | La Plata | Argentina |
| Research Site | Quilmes | Argentina |
| Research Site | San Miguel de Tucumán | Argentina |
| Research Site | Curitiba | Brazil |
| Research Site | Goiânia | Brazil |
| Research Site | Juiz de Fora | Brazil |
| Research Site | Porto Alegre | Brazil |
| Research Site | Salvador | Brazil |
| Research Site | São Paulo | Brazil |
| Research Site | Plovdiv | Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Québec | Quebec | Canada |
| Research Site | Sherbrooke | Quebec | Canada |
| Research Site | Osorno | Chile |
| Research Site | Santiago | Chile |
| Research Site | Viña del Mar | Chile |
| Research Site | Bordeaux | France |
| Research Site | Le Kremlin-Bicêtre | France |
| Research Site | Paris | France |
| Research Site | Strasbourg | France |
| Research Site | Berlin | Germany |
| Research Site | Cologne | Germany |
| Research Site | Dresden | Germany |
| Research Site | Frankfurt | Germany |
| Research Site | Kiel | Germany |
| Research Site | Leipzig | Germany |
| Research Site | Mainz | Germany |
| Research Site | Münster | Germany |
| Research Site | Regensburg | Germany |
| Research Site | Würzburg | Germany |
| Research Site | Budapest | Hungary |
| Research Site | Debrecen | Hungary |
| Research Site | Miskolc | Hungary |
| Research Site | Zalaegerszeg | Hungary |
| Research Site | Bangalore | India |
| Research Site | Secunderabad | India |
| Research Site | Brescia | Italy |
| Research Site | Florence | Italy |
| Research Site | Milan | Italy |
| Research Site | Padova | Italy |
| Research Site | Pisa | Italy |
| Research Site | Roma | Italy |
| Research Site | Kingston | Jamaica |
| Research Site | Chihuahua City | Mexico |
| Research Site | Guadalajara | Mexico |
| Research Site | México | Mexico |
| Research Site | San Luis Potosà City | Mexico |
| Research Site | Amsterdam | Netherlands |
| Research Site | Lima | Peru |
| Research Site | San Borja | Peru |
| Research Site | Cebu City | Philippines |
| Research Site | Iloilo City | Philippines |
| Research Site | Manila | Philippines |
| Research Site | Bialystok | Poland |
| Research Site | Bydgoszcz | Poland |
| Research Site | Katowice | Poland |
| Research Site | Krakow | Poland |
| Research Site | Lublin | Poland |
| Research Site | Olsztyn | Poland |
| Research Site | Poznan | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Brasov | Romania |
| Research Site | Bucharest | Romania |
| Research Site | Cluj-Napoca | Romania |
| Research Site | Tg Mures | Romania |
| Research Site | Cape Town | South Africa |
| Research Site | Durban | South Africa |
| Research Site | Johannesburg | South Africa |
| Research Site | Pinelands | South Africa |
| Research Site | Soweto | South Africa |
| Research Site | Barcelona | Spain |
| Research Site | Guadalajara | Spain |
| Research Site | La Laguna (Tenerife) | Spain |
| Research Site | Madrid | Spain |
| Research Site | Majadahonda | Spain |
| Research Site | Málaga | Spain |
| Research Site | Mérida | Spain |
| Research Site | Santiago de Compostela | Spain |
| Research Site | Seville | Spain |
| Research Site | Bangkok | Thailand |
| Research Site | Brighton | United Kingdom |
| Research Site | Cambridge | United Kingdom |
| Research Site | Cannock | United Kingdom |
| Research Site | Guildford | United Kingdom |
| Research Site | Leeds | United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | Manchester | United Kingdom |
| Derived |
| Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2. |
| 31660791 | Derived | Brohawn PZ, Streicher K, Higgs BW, Morehouse C, Liu H, Illei G, Ranade K. Type I interferon gene signature test-low and -high patients with systemic lupus erythematosus have distinct gene expression signatures. Lupus. 2019 Nov;28(13):1524-1533. doi: 10.1177/0961203319885447. Epub 2019 Oct 29. |
Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
| FG002 | Sifalimumab 600 mg | Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
| FG003 | Sifalimumab 1,200 mg | Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all participants who were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
| BG001 | Sifalimumab 200 Milligram (mg) | Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
| BG002 | Sifalimumab 600 mg | Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
| BG003 | Sifalimumab 1,200 mg | Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) | SRI (4) responder is defined as: 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points (with increased deoxyribonucleic acid [DNA] binding item of SLEDAI-2K score based on the ANA Multi-Lyte® ANA-II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in British Isles Lupus Assessment Group (BILAG-2004) (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline). | The modified intent-to-treat (mITT) population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. | Posted | Number | percentage of participants | Day 365 |
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| Primary | Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants | SRI (4) responder is defined as: 1) a reduction in baseline SLEDAI-2K disease activity score of >=4 points (with increased DNA binding item of SLEDAI-2K score based on the ANA Multi-Lyte® ANA-II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in BILAG-2004 (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline). | The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, "N" signifies number of participants with positive diagnostic test. | Posted | Number | percentage of participants | Day 365 |
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| Secondary | Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day | Percentage of participants on >=10 mg/day oral corticosteroids (OCS) at baseline who were able to taper it to <=7.5 mg/day by Day 365 were recorded. | The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, "N" signifies number of participants on >=10 mg/day oral prednisone (or equivalent) at baseline. | Posted | Number | percentage of participants | Day 365 |
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| Secondary | Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction | The CLASI consists of two scores, the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. The percentage of participants with a CLASI activity score >=10 at baseline who achieved a clinically significant (>=4-point) reduction at Day 365 were reported. | The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, "N" signifies number of participants with a CLASI activity score >=10 at baseline. | Posted | Number | percentage of participants | Day 365 |
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| Secondary | Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). | The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, "N" signifies number of participants with a FACIT-fatigue score <49 at baseline. | Posted | Number | percentage of participants | Day 365 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of investigational product, for the period extending until the end of participant participation in the study. | The safety population included all participants who received any investigational product. | Posted | Number | participants | Day 1 up to Week 74 |
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| Secondary | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Laboratory investigations included hematology, serum chemistries and urinalysis parameters. Participants with clinically significant abnormalities in these laboratory investigations recorded as TEAEs were reported. | The safety population included all participants who received any investigational product. | Posted | Number | participants | Day 1 up to Week 61 |
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| Secondary | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiratory rate. Vital signs abnormalities recorded as TEAEs were reported. | The safety population included all participants who received any investigational product. | Posted | Number | participants | Day 1 up to Week 61 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs | The 12-lead ECG data were summarized and evaluated. Number of participants with clinically significant abnormal ECG findings as assessed by cardiologist were recorded and reported as TEAEs. | The safety population included all participants who received any investigational product. | Posted | Number | participants | Day 1 up to Week 56 |
|
Day 1 up to Week 74
TEAE defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of investigational product, for the period extending until the end of participant participation in the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo matching to sifalimumab administered intravenously for 48 weeks (Day 337). | 19 | 108 | 93 | 108 | ||
| EG001 | Sifalimumab 200 mg | Sifalimumab 200 milligram (mg) administered intravenously for 48 weeks (Day 337). | 16 | 108 | 94 | 108 | ||
| EG002 | Sifalimumab 600 mg | Sifalimumab 600 mg administered intravenously for 48 weeks (Day 337). | 22 | 108 | 96 | 108 | ||
| EG003 | Sifalimumab 1200 mg | Sifalimumab 1,200 mg administered intravenously for 48 weeks (Day 337). | 21 | 107 | 92 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diverticulum oesophageal | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Lip ulceration | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Salivary gland calculus | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Tongue oedema | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Corneal infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Encephalitis viral | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Enterocolitis bacterial | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Ludwig angina | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Septic embolus | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Stab wound | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Simple partial seizures | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vasculitis cerebral | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Abortion spontaneous incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Laryngeal polyp | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ischaemic limb pain | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabor Illei, MD, Senior Director, Clinical Development | MedImmune, LLC | 301-398-0000 | IlleiG@Medimmune.com |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C568334 | sifalimumab |
Not provided
Not provided
Not provided
| Male |
|
| Odds Ratio (OR) |
| 1.60 |
| 2-Sided |
| 90 |
| 1.01 |
| 2.54 |
| Superiority or Other |
| Regression, Logistic | 0.031 | Odds Ratio (OR) | 1.84 | 2-Sided | 90 | 1.16 | 2.94 | Superiority or Other |
| OG002 | Sifalimumab 600 mg | Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
| OG003 | Sifalimumab 1,200 mg | Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
|
|
|
| OG003 | Sifalimumab 1,200 mg | Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
|
|
|
| OG002 | Sifalimumab 600 mg | Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
| OG003 | Sifalimumab 1,200 mg | Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
|
|
|
| OG002 | Sifalimumab 600 mg | Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
| OG003 | Sifalimumab 1,200 mg | Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
|
|
|
| OG002 | Sifalimumab 600 mg | Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
| OG003 | Sifalimumab 1,200 mg | Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
|
|
| OG003 | Sifalimumab 1,200 mg | Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
|
|
| OG003 | Sifalimumab 1,200 mg | Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
|
|
| OG003 | Sifalimumab 1,200 mg | Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. |
|
|