A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01283139
• Date of registration: 20/01/2011
• Prospective Registration: Yes
• Primary sponsor: MedImmune LLC
• Public title: A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
• Scientific title: A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
• Date of first enrolment: March 31, 2011
• Target sample size: 834
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01283139
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Argentina, Brazil, Bulgaria, Canada, Chile, France, Germany, Hungary, India, Italy, Jamaica, Mexico, Netherlands, Peru, Philippines, Poland, Romania, South Africa, Spain, Thailand, United Kingdom, United States

Contacts

• Name: Gabor Illei, MD
• Affiliation: MedImmune LLC

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Biological: Sifalimumab 1,200 mg

Biological: Sifalimumab 200 mg

Other: Placebo

Biological: Sifalimumab 600 mg

Primary Outcome(s)

Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants [Time Frame: Day 365]

Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) [Time Frame: Day 365]

Secondary Outcome(s)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) [Time Frame: Day 1 up to Week 74]

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 [Time Frame: Day 365]

Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs [Time Frame: Day 1 up to Week 56]

Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Day 1 up to Week 61]

Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale [Time Frame: 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 [Time Frame: Day 365]

Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Day 1 up to Week 61]

Secondary ID(s)

2010-024069-30

CD-IA-MEDI-545-1067

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/07/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01283139