A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
2 other identifiers
interventional
834
22 countries
107
Brief Summary
To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2011
Typical duration for phase_2
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2011
CompletedFirst Posted
Study publicly available on registry
January 25, 2011
CompletedStudy Start
First participant enrolled
March 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2014
CompletedResults Posted
Study results publicly available
July 11, 2016
CompletedApril 19, 2018
March 1, 2018
2.6 years
January 20, 2011
June 1, 2016
March 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (7)
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
Day 365
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
Day 365
Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
Day 365
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)
Day 1 up to Week 74
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Day 1 up to Week 61
- +2 more secondary outcomes
Study Arms (4)
Sifalimumab 200 milligram (mg)
EXPERIMENTALSifalimumab 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
EXPERIMENTALSifalimumab 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
EXPERIMENTALSifalimumab 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 COMPARATORPlacebo 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.
Interventions
Sifalimumab 200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.
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 intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (107)
Research Site
La Jolla, California, United States
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Palm Desert, California, United States
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San Leandro, California, United States
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Fort Lauderdale, Florida, United States
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Orlando, Florida, United States
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Stockbridge, Georgia, United States
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Idaho Falls, Idaho, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Lansing, Michigan, United States
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Brooklyn, New York, United States
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Manhasset, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Dallas, Texas, United States
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Seattle, Washington, United States
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Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aire, Argentina
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Ciudad de Buenos Aires, Argentina
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La Plata, Argentina
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Quilmes, Argentina
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San Miguel de Tucumán, Argentina
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Curitiba, Brazil
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Goiânia, Brazil
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Juiz de Fora, Brazil
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Porto Alegre, Brazil
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Salvador, Brazil
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São Paulo, Brazil
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Osorno, Chile
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Santiago, Chile
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Viña del Mar, Chile
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Bordeaux, France
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Le Kremlin-Bicêtre, France
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Paris, France
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Strasbourg, France
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Berlin, Germany
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Cologne, Germany
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Dresden, Germany
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Frankfurt, Germany
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Kiel, Germany
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Leipzig, Germany
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Mainz, Germany
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Münster, Germany
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Regensburg, Germany
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Würzburg, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Miskolc, Hungary
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Zalaegerszeg, Hungary
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Bangalore, India
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Secunderabad, India
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Brescia, Italy
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Florence, Italy
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Milan, Italy
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Padua, Italy
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Pisa, Italy
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Roma, Italy
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Kingston, Jamaica
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Chihuahua City, Mexico
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Guadalajara, Mexico
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México, Mexico
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San Luis Potosí City, Mexico
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Amsterdam, Netherlands
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Lima, Peru
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San Borja, Peru
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Cebu City, Philippines
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Iloilo City, Philippines
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Manila, Philippines
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Bialystok, Poland
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Bydgoszcz, Poland
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Katowice, Poland
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Krakow, Poland
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Lublin, Poland
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Olsztyn, Poland
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Poznan, Poland
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Warsaw, Poland
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Brasov, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Tg Mures, Romania
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Cape Town, South Africa
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Durban, South Africa
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Johannesburg, South Africa
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Pinelands, South Africa
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Soweto, South Africa
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Barcelona, Spain
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Guadalajara, Spain
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La Laguna (Tenerife), Spain
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Madrid, Spain
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Majadahonda, Spain
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Málaga, Spain
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Mérida, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Bangkok, Thailand
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Brighton, United Kingdom
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Cambridge, United Kingdom
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Cannock, United Kingdom
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Guildford, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
Related Publications (3)
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.
PMID: 27009916BACKGROUNDHannon 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.
PMID: 33687069DERIVEDBrohawn 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.
PMID: 31660791DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gabor Illei, MD, Senior Director, Clinical Development
- Organization
- MedImmune, LLC
Study Officials
- STUDY DIRECTOR
Gabor Illei, MD
MedImmune LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2011
First Posted
January 25, 2011
Study Start
March 31, 2011
Primary Completion
November 14, 2013
Study Completion
April 17, 2014
Last Updated
April 19, 2018
Results First Posted
July 11, 2016
Record last verified: 2018-03