Systemic Lupus Erythematosus
Conditions
Keywords
Lupus, Antibody, B-Cell Immunotherapy
Brief summary
Epratuzumab is an investigational antibody designed to help treat Systemic Lupus Erythematosus (SLE). The purpose of the study is to obtain additional long-term information regarding the safety and efficacy of continued maintenance-cycle administrations of Epratuzumab.
Detailed description
Due to the logistical considerations, UCB has decided to consolidate the Phase II and Phase III open-label extension trials. Subjects completing this study will be offered the option of continuing to receive epratuzumab through participation in Phase III open-label extension study SL0012 (NCT01408576).
Interventions
BIOLOGICALEpratuzumab
360 mg/m\^2 four consecutive 12-week maintenance cycles beginning with 2 consecutive weekly administrations each lasting ≤ 1 hour
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have participated in SL0003 or SL0004 and benefitted from participation in those studies
Exclusion criteria
* Development of toxicity to epratuzumab * Significant protocol deviations during the SL0003 or SL0004 studies * Evidence of significant infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects reporting at least 1 serious adverse event (SAE) from entry Visit 1 through end of treatment (approximately 6 years) | From Entry Visit 1 through end of treatment (approximately 6 years) |
| Number of subjects prematurely discontinuing due to a treatment emergent adverse event (TEAE) from entry Visit 1 through end of treatment (approximately 6 years) | From Entry Visit 1 through end of treatment (approximately 6 years) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with anti-epratuzumab antibody in plasma at Week 240 | Week 240 | — |
| Time to treatment failure from First Visit through end of treatment (approximately 6 years) | From the first infusion of the first treatment cycle and continuing through end of treatment (approximately 6 years) | Treatment failure is defined as initiation of a protocol specified prohibited medication. |
| Epratuzumab plasma concentration levels at Week 0 | Week 0 | — |
| Epratuzumab plasma concentration levels at Week 48 | Week 48 | — |
| Epratuzumab plasma concentration levels at Week 96 | Week 96 | — |
| Epratuzumab plasma concentration levels at Week 144 | Week 144 | — |
| Epratuzumab plasma concentration levels at Week 192 | Week 192 | — |
| Epratuzumab plasma concentration levels at Week 240 | Week 240 | — |
| Number of subjects with anti-epratuzumab antibody in plasma at Week 288 | Week 288 | — |
| Number of subjects with anti-epratuzumab antibody in plasma at Week 0 | Week 0 | — |
| Number of subjects with anti-epratuzumab antibody in plasma at Week 48 | Week 48 | — |
| Number of subjects with anti-epratuzumab antibody in plasma at Week 96 | Week 96 | — |
| Number of subjects with anti-epratuzumab antibody in plasma at Week 144 | Week 144 | — |
| Number of subjects with anti-epratuzumab antibody in plasma at Week 192 | Week 192 | — |
| Change from Baseline in Short Form 36-items Health Survey (SF-36) Mental Composite Summary (MCS) Score | Baseline, Last Visit | — |
| Change from Baseline in Patient's Global Assessment of Disease Activity (PtGADA) | Baseline, Last Visit | Five point scale where 1 = very poor and 5 = very good. |
| Change from Baseline in Physician's Global Assessment of Disease Activity (PGADA) | Baseline, Last Visit | Five point scale where 1 = very poor and 5 = very good. |
| Subject Epratuzumab plasma concentration levels at Week 288 | Week 288 | — |
| Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Score | Baseline, Last Visit | — |
Countries
United States
Outcome results
None listed