A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.

Official Title
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A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: Dapirolizumab pegol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapirolizumab pegol<br>Subjects will receive dapriolizumab pegol throughout the Treatment Period. | Drug: Dapirolizumab pegol<br>* Subjects will receive dapirolizumab pegol at prespecified time-points.<br>* Other names: CDP7657;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events (TEAEs) during the study | 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. | From Baseline (Day 1) until Safety Follow-Up (up to Week 110) | 
| Incidence of serious treatment-emergent adverse events during the study | 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 | From Baseline (Day 1) until Safety Follow-Up (up to Week 110) | 
| Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation | 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. | From Baseline (Day 1) until Safety Follow-Up (up to Week 110) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through 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). | Week 24 | 
| Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through 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). | Week 52 | 
| Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through 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). | Week 104 | 
| Achievement of LLDAS at ≥50% of all visits | 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 | From Baseline (Day 1) until End of Treatment (Week 104) | 
| Achievement of BICLA response at 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. | Week 24 | 
| Achievement of BICLA response at 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. | Week 52 | 
| Achievement of BICLA response at 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. | Week 104 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLE, Systemic lupus erythematosus, Dapirolizumab pegol, DZP