Phase 3
N=1,250
Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT01408576 ↗Enrolled (actual)
1,250
Serious AEs
24.4%
Results posted
Oct 2018
Primary outcome: Primary: Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) — 26; 45; 25; 51 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Epratuzumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) |
26; 45; 25; 51; 96 | — |
| PRIMARY Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) |
10.7; 9.1; 4.9; 6.8; 7.7 | — |
| PRIMARY Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks) |
81; 119; 104; 185; 304 | — |
| PRIMARY Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks) |
33.2; 23.9; 20.5; 24.6; 24.4 | — |
| SECONDARY Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index |
74; 66; 78; 152; 218 | — |
| SECONDARY Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index |
35.7; 29.9; 27.1; 29.8; 29.9 | — |
| SECONDARY Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index |
74; 66; 78; 152; 218 | — |
| SECONDARY The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index |
39.8; 21.6; 26.2; 31.4; 27.6 | — |
Summary
The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)
Eligibility Criteria
Inclusion Criteria
- Subject has completed the double-blind study SL0009 (NCT01262365) or SL0010 (NCT01261793) or terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
- Subject has completed open-label study SL0006 (NCT00383513) or SL0008 (NCT00660881), and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
- Women of childbearing potential must agree to use an acceptable method of birth control
Exclusion Criteria
- Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A disease
- Subjects with active, severe SLE disease activity which involves the renal system
- Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
- Substance abuse or dependence
- History of malignant cancer
- Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion
Data sourced from ClinicalTrials.gov (NCT01408576). 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.