A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dapirolizumab pegol Subjects will receive dapriolizumab pegol throughout the Treatment Period. |
Drug: Dapirolizumab pegol
Subjects will receive dapirolizumab pegol at prespecified time-points.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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, whether or not these events are related to study treatment.
Secondary Outcome Measures
- 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: 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 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 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: 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 No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and 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: 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 No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and 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.
Eligibility Criteria
Criteria
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 placebo controlled (PBO-controlled) 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sl0046 50328 | Tucson | Arizona | United States | 85704 |
| 2 | Sl0046 50383 | Beverly Hills | California | United States | 90211 |
| 3 | Sl0046 50275 | La Palma | California | United States | 90623-1730 |
| 4 | Sl0046 50316 | San Leandro | California | United States | 94578 |
| 5 | Sl0046 50339 | Denver | Colorado | United States | 80230 |
| 6 | Sl0046 50059 | Ormond Beach | Florida | United States | 32174 |
| 7 | Sl0046 50329 | Tampa | Florida | United States | 33606 |
| 8 | Sl0046 50240 | Idaho Falls | Idaho | United States | 83404 |
| 9 | Sl0046 50015 | Hagerstown | Maryland | United States | 21740 |
| 10 | Sl0046 50238 | Charlotte | North Carolina | United States | 28210 |
| 11 | Sl0046 50001 | Jackson | Tennessee | United States | 38305 |
| 12 | Sl0046 50050 | Beckley | West Virginia | United States | 25801 |
| 13 | Sl0046 60014 | Tucuman | Argentina | ||
| 14 | Sl0046 40123 | Bruxelles | Belgium | ||
| 15 | Sl0046 40006 | Plovdiv | Bulgaria | ||
| 16 | Sl0046 40189 | Plovdiv | Bulgaria | ||
| 17 | Sl0046 40380 | Sofia | Bulgaria | ||
| 18 | Sl0046 50259 | Rimouski | Canada | ||
| 19 | Sl0046 50044 | Trois-rivieres | Canada | ||
| 20 | Sl0046 60015 | Santiago de Chile | Chile | ||
| 21 | Sl0046 40078 | Leipzig | Germany | ||
| 22 | Sl0046 40412 | Budapest | Hungary | ||
| 23 | Sl0046 40499 | Szekesfehervar | Hungary | ||
| 24 | Sl0046 40119 | Bydgoszcz | Poland | ||
| 25 | Sl0046 40398 | Katowice | Poland | ||
| 26 | Sl0046 40502 | Krakow | Poland | ||
| 27 | Sl0046 40151 | Lublin | Poland | ||
| 28 | Sl0046 40044 | Poznan | Poland | ||
| 29 | Sl0046 40090 | Poznan | Poland | ||
| 30 | Sl0046 40097 | Warszawa | Poland | ||
| 31 | Sl0046 40098 | Warszawa | Poland | ||
| 32 | Sl0046 40397 | Wroclaw | Poland | ||
| 33 | Sl0046 40393 | Belgrade | Serbia | ||
| 34 | Sl0046 40101 | Sabadell | Spain | ||
| 35 | Sl0046 40099 | Vigo | Spain | ||
| 36 | Sl0046 20113 | Taichung | Taiwan | ||
| 37 | Sl0046 20095 | Taipei | Taiwan |
Sponsors and Collaborators
- UCB Biopharma SRL
Investigators
- Study Director: UCB Cares, 001 844 599 2273 (UCB)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SL0046
- 2019-003409-83