A MULTICENTER, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TOEVALUATE THE EFFICACY AND SAFETY OFDAPIROLIZUMAB PEGOL IN STUDY PARTICIPANTS WITHMODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUSERYTHEMATOSUS
- Conditions
- -M32 Systemic lupus erythematosusSystemic lupus erythematosusM32
- Registration Number
- PER-046-20
- Lead Sponsor
- CB Biopharma SRL,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Age
1. Study participant must be ≥16 years of age, unless restricted by local regulation, at the time
of signing the Informed Consent form (ICF).
Type of participant and disease characteristics
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/relapsingremitting
SLE despite stable SOC medication defined as:Diagnosed with SLE at least 24
weeks before study entry by a qualified physician (eg, rheumatologist, internal medicine
expert, nephrologist, or dermatologist)
Weight
3. Body weight ≥40kg and ≤160kg.
Sex
4. Female and/or male
A male study participant must agree to use contraception, as detailed in Section 10.4, during
the Treatment Period and for at least 17 weeks after the final dose of study medication and
refrain from donating sperm during this period.
A female study participant is eligible to participate if she is not pregnant, not breastfeeding,
and at least 1 of the following conditions applies:
Not a woman of childbearing potential (WOCBP) as defined in Section 10.4 of the
protocol, or
A WOCBP who agrees to follow the contraceptive guidance in Section 10.4 of the final
protocol during the treatment period and for at least 17 weeks after the final dose of study
medication.
Informed consent
5. 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 this protocol.
Study participants are excluded from the study if any of the following criteria apply:
Medical conditions
General
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. This includes study
participants with a life threatening condition (eg, CTCAE grade 4 conditions, CAPS, acute
severe renal failure, acute severe central nervous system [CNS] manifestations)
2. Study participant has moderate to severe disease activity as defined per inclusion criterion 2d
at study entry due to an acute flare but does not fulfill at least one of the following criteria at
the Screening Visit:
≥1 additional disease flare within the last 24 weeks prior to Screening (as per medical
record) OR
Evidence for anti-dsDNA antibodies in combination with C3 Complement C4 African-American OR
Age <25
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 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 study entry), basal cell carcinoma, or dermatological squamous cell
carcinoma (after complete resection not later than 24 weeks prior to study entry).
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 or have donated plasma or
platelets within 14 days prior to the Screening Visit.
9. Study participants with a history of thromboembolic events within 52 weeks of Screening
(Visit 1), 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 a vascular graft, valvular heart disease, atrial fibrillation, or any other
heart rhythm disorder associated with an increased risk for thromboembolic events.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Achievement of response to BICLA at week 48<br>Measure:To assess the ability of DZP as a complementary treatment for SOC medication to achieve clinically relevant, long-term improvement in moderate to severe disease activity.<br>Timepoints:In week 48.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:• Achievement of the response to BICLA in week 24.<br>• Achievement of the response to BICLA in week 12.<br>Measure:. To evaluate the ability of DZP as an<br>add-on treatment to SOC medication to achieve fast, clinically relevant improvement of moderate to severe disease activity<br><br>. To evaluate the ability of DZP as an add-on treatment to SOC medication to achieve long term control of disease activity.<br><br>. 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.<br><br>. 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<br>commonly used in clinical practice.<br>Timepoints:Week 12 and 24.<br>