Phase 3
N=791
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT01261793 ↗Enrolled (actual)
791
Serious AEs
17.8%
Results posted
Jun 2018
Primary outcome: Primary: The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index — 33.5; 34.1; 35.2 Percentage of responders — p==0.899
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Epratuzumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index |
33.5; 34.1; 35.2 | =0.899 |
| SECONDARY The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index |
32.3; 33.0; 43.6 | — |
| SECONDARY The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index |
30.0; 32.2; 40.9 | — |
| SECONDARY The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index |
32.7; 33.0; 36.7 | — |
| SECONDARY Change From Baseline in Daily Corticosteroid Dose at Week 24 |
4.6; 10.0; 8.7; 20.9; 18.0; 18.2 | — |
| SECONDARY Change From Baseline in Daily Corticosteroid Dose at Week 48 |
6.5; 13.8; 14.8; 20.9; 13.4; 15.9 | — |
Summary
The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE).
Eligibility Criteria
Inclusion Criteria
- Positive antinuclear antibodies (ANA) at Screening (Visit 1)
- Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
- Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
- Active moderate to severe SLE disease as demonstrated by SLE disease activity index (SLEDAI) total score
- On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials
Exclusion Criteria
- Subjects who are breastfeeding, pregnant, or plan to become pregnant
- Subjects with active, severe SLE disease activity which involves the renal system
- Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
- Subjects with the evidence of an immunosuppressive state
- Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
- History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
- Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
- Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
- Subjects with substance abuse or dependence or other relevant concurrent medical condition
- Subjects with history of thromboembolic events within 1 year of screening Visit.
- Subjects with significant hematologic abnormalities
- Subject has received treatment with other anti- B cell antibodies within 12 months prior to screening (visit 1)
- Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
- Subject has previously participated in this study or has previously received epratuzumab treatment.
Data sourced from ClinicalTrials.gov (NCT01261793). 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.