Systemic Lupus Erythematosus
Conditions
Keywords
Systemic lupus erythematosus, Dapirolizumab pegol, SLE, DZP
Brief summary
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
Interventions
Subjects will receive dapirolizumab pegol at prespecified time-points.
Sponsors
UCB Biopharma SRL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The participant could, in the opinion of the Investigator, benefit from long-term dapirolizumab pegol (DZP) treatment * The participant completed one of the parent studies within 4 weeks prior to entry to this study
Exclusion criteria
\- Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition or ongoing malignancies at the start of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) during the study | From Baseline (Day 1) until Safety Follow-Up (up to Week 110) | Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment. |
| Incidence of serious treatment-emergent adverse events during the study | From Baseline (Day 1) until Safety Follow-Up (up to Week 110) | A serious treatment-emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalisation or prolongation of existing hospitalisation * Results in persistent disability/incapacity * Is a congenital anomaly or birth defect * Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above |
| Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation | From Baseline (Day 1) until Safety Follow-Up (up to Week 110) | Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, and leading to permanent drug discontinuation whether or not these events are related to study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24 | Week 24 | BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010). |
| Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52 | Week 52 | BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010). |
| Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104 | Week 104 | BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010). |
| Achievement of LLDAS at ≥50% of all visits | From Baseline (Day 1) until End of Treatment (Week 104) | Low lupus disease activity state (LLDAS) is defined as: * No significant disease activity as per SLEDAI-2K and BILAG 2004 (SLEDAI-2K score ≤4 with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) * No new and/or worsening disease activity defined as no SLEDAI-2K component documented as present that was not documented present at previous visit * PGA ≤33 mm * Prednisone equivalent systemic dose for systemic lupus erythematosus (SLE) indication ≤7.5 mg per day * Stable standard maintenance doses of immunosuppressive drugs as allowed by protocol |
| Achievement of BICLA response at Week 24 | Week 24 | A study participant is considered to be a BILAG 2004-based Composite Lupus Assessment (BICLA) responder if all of the following is fulfilled: 1. British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and 2. No worsening in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and 3. No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale The parent studies Baseline will be used as reference point. |
| Achievement of BICLA response at Week 52 | Week 52 | A study participant is considered to be a BICLA responder if all of the following is fulfilled: 1. BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and 2. No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and 3. No worsening in the PGA compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale The parent studies Baseline will be used as reference point. |
| Achievement of BICLA response at Week 104 | Week 104 | A study participant is considered to be a BICLA responder if all of the following is fulfilled: 1. BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and 2. No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and 3. No worsening in the PGA compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale The parent studies Baseline will be used as reference point. |
Countries
Argentina, Belgium, Bulgaria, Canada, Chile, China, Colombia, Czechia, Germany, Greece, Hungary, Italy, Mexico, Peru, Philippines, Poland, Romania, Serbia, South Korea, Spain, Taiwan, United States
Contacts
STUDY_DIRECTORUCB Cares
001 844 599 2273 (UCB)
Outcome results
None listed