Phase 3
N=793
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT01262365 ↗Enrolled (actual)
793
Serious AEs
17.4%
Results posted
Jun 2018
Primary outcome: Primary: The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index — 34.1; 39.8; 37.5 percentage of participants — p==0.175
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Epratuzumab (Drug); Placebo (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 |
34.1; 39.8; 37.5 | =0.175 |
| SECONDARY The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index |
33.7; 43.0; 39.1 | — |
| SECONDARY The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index |
31.3; 42.2; 39.9 | — |
| SECONDARY The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index |
33.3; 41.8; 35.1 | — |
| SECONDARY Change From Baseline in Daily Corticosteroid Dose at Week 24 |
9.2; 8.2; 6.9; 10.8; 16.4; 14.9 | — |
| SECONDARY Change From Baseline in Daily Corticosteroid Dose at Week 48 |
14.1; 11.9; 10.1; 10.4; 14.3; 12.5 | — |
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 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 (NCT01262365). 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.