Phase 2
N=432
A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT01283139 ↗Enrolled (actual)
432
Serious AEs
18.1%
Results posted
Jul 2016
Primary outcome: Primary: Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) — 45.4; 58.3; 56.5; 59.8 percentage of participants — p=0.057
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sifalimumab 200 mg (Biological); Sifalimumab 600 mg (Biological); Sifalimumab 1,200 mg (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) |
45.4; 58.3; 56.5; 59.8 | 0.057 |
| PRIMARY Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants |
42.0; 57.5; 50.0; 57.5 | 0.042 sig |
| 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 |
6.5; 8.2; 9.4; 6.2; 93.5; 91.8 | 0.808 |
| 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 |
48.6; 72.7; 57.6; 73.1; 51.4; 27.3 | 0.044 sig |
| SECONDARY Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale |
30.5; 38.1; 42.2; 35.6; 69.5; 61.9 | 0.270 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) |
94; 97; 97; 93; 19; 16 | — |
| SECONDARY Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) |
1; 4; 4; 2; 3; 1 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) |
3; 2; 6; 7; 7; 4 | — |
| SECONDARY Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs |
2; 0; 1; 0 | — |
Summary
To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01283139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.