M32 Systemic lupus erythematosus Systemic lupus erythematosus
Conditions
Interventions
Name: Dapirolizumab Pegol Infusion 24mg/kg every 4 weeks + Standard of Care Pharmaceutical form: Lyophilized powder for solution for infusion Dose: 24mg/kg Route of administration: IV Infusion Duratio
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Study participant must be =16 years of age. 2. Study participants who have moderate to severe disease activity due to either persisting active SLE or due to an acute worsening of SLE in the scope of frequent flaring/relapsing-remitting SLE despite stable SOC medication. 3. Body weight =40kg and =160kg 4. Female and/or male 5. Study participant is capable of giving signed informed consent as described in Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
Exclusion criteria
Exclusion criteria: 1. Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study. 2. Study participant has moderate to severe disease activity (as defined per inclusion criterion 2.d) at the Screening Visit (V1) due to an acute flare but does not fulfill at least one of the following criteria in addition to the Screening Visit: - =1 additional disease flare within the last 24 weeks prior to Screening (as per medical record) OR - Anti-dsDNA positivity in combination with C3 <LLN as per central laboratory OR - Complement C4 <LLN as per central laboratory OR - African-American OR - Age <25 years 3. Study participant has a history of chronic alcohol or drug abuse within the previous 24 weeks. 4. Study participant has a known hypersensitivity to any components of DZP including PEG or comparative drugs (and/or an investigational device) as stated in this protocol. 5. Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies. This includes systemic reactions due to latex allergy. 6. Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ (after complete resection [eg, curettage, electrodesiccation] not later than 4 weeks prior to the Screening Visit [V1]), basal cell carcinoma, or dermatological squamous cell carcinoma (after complete resection not later than 24 weeks prior to the Screening Visit [V1]). 7. Study participants who have had major surgery (including joint surgery) within the 24 weeks prior to Screening, or planned surgery within 24 weeks after entering the study. 8. Study participants who have had significant blood loss or have donated or received 1 or more units (450mL) of blood within 30 days prior to the Screening Visit (V1) or have donated plasma or platelets within 14 days prior to the Screening Visit (V1). 9. Study participants with a history of thromboembolic events within 52 weeks of the Screening Visit (V1), including but not limited to the following: deep venous thrombosis, pulmonary embolism, cortical sinus thrombosis, myocardial infarction, stroke, transient ischemic attack, or arterial insufficiency causing digital gangrene or tissue necrosis. 10. Study participants with a history of catastrophic APS or saddle pulmonary embolism. 11. Study participant has an increased risk for thromboembolic events due to an ongoing heart disease or due to a medical device, including but not limited to vascular graft, valvular heart disease, atrial fibrillation, or a heart rhythm disorder. 12. Study participant has a BILAG 2004 Grade A in the musculoskeletal system due to severe arthritis only AND no BILAG 2004 Grade A or B in any other organ system AND no current (within the past 4 weeks) evidence for synovitis based on imaging methods such as magnetic resonance imaging or doppler-sonography. 13. Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of BICLA response at Week 48 NAME OF THE RESULT: To evaluate the ability of DZP as an add-on treatment to SOC medication to achieve clinically relevant long-term improvement of moderate to severe disease activity PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Achievement of BICLA response at Week 48 NAME OF THE RESULT: To evaluate the ability of DZP as an add-on treatment to SOC medication to achieve clinically relevant long-term improvement of moderate to severe disease activity PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 48;"Achievement of BICLA response at Week 24 Achievement of BICLA response at Week 12" NAME OF THE RESULT: To evaluate the ability of DZP as an add-on treatment to SOC medication to achieve fast, clinically relevant improvement of moderate to severe disease activity PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Weeks 12 and 24;Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48 NAME OF THE RESULT: To evaluate the ability of DZP as an add-on treatment to SOC medication to achieve long-term control of disease activity PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 48;Achievement of LLDAS in =50% of post Baseline visits through Week 48 NAME OF THE RESULT: To evaluate the ability of DZP as an add-on treatment to SOC medication to achieve and maintain the treat-to-target goal: low disease activity with low/acceptable corticosteroid dose over time PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 48;Change from Baseline in SLEDAI-2K at Week 48 NAME OF THE RESULT: To evaluate the ability of DZP as an add-on treatment to SOC medication to achieve improvement of disease activity as measured by numerical disease state score commonly used in clinical practice PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 48 | — |
Countries
Argentina, Austria, Belgium, Canada, Chile, China, Denmark, France, Germany, Greece, Italy, Japan, Korea South, Peru, Poland, Portugal, Serbia, Spain, Taiwan, United Kindgdom, United States
Contacts
Public ContactBERTHA DEL PILAR CABRERA
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed