Systemic lupus erythematosus (SLE) MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Study participant must be =16 years of age, unless restricted by local regulation, at the time of signing the Informed Consent form (ICF) - Study participants who have moderate to severe disease activity due to either persisting active systemic lupus erythematosus (SLE) or due to an acute worsening of SLE in the scope of frequent flaring/relapsing-remitting SLE despite stable standard of care(SOC) medication defined as: a. Diagnosed with SLE at least 24 weeks before the Screening Visit by a qualified physician b. Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE c. With serological evidence for SLE at Screening as demonstrated by at least 1 of the following: i) Evidence for anti-dsDNA (defined as evidence for anti-dsDNA antibodies in central laboratory) ii) Either complement C3 =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: - 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 - 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 - 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 - 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 - Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE - Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study - Study participant has clinically significant active or latent infection - Study participant had a reactivated latent infection (eg, cytomegalovirus, herpes simplex virus, or herpes zoster infection) or opportunistic infection (including but not limited to, pneumocystis, cytomegalovirus, or severe herpes zoster infection) within 12 weeks prior to the first study medication infusion (Visit 2) or is currently receiving suppressive therapy for an opportunistic infection - Study participants who have received live/live attenuated vaccines within 6 weeks prior to the first study medication infusion - Study participant has used the prohibited medications defined in the Protocol - Study participant has previously been randomized within this study or has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP - Study participant has participated in another study of an investigational medicinal product (IMP) within the previous 12 weeks or 5 half-lives of the IMP whatever is longer, or is currently participating in another study of an IMP - Study participant has chronic kidney failure stage 4, manifested by estimated glomerular filtration rate (eGFR) 2.5 mg/dL, or participant has proteinuria >3g/day, or protein:creatinine ratio >340 mg/mmol at the Screening Visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long-term improvement of moderate to severe disease activity ;Secondary Objective: Evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication: - to achieve fast, clinically relevant improvement of moderate to severe disease activity - to achieve long-term control of disease activity - to achieve and maintain the treat-to-target goal: low disease activity with low/acceptable corticosteroid dose over time - to achieve improvement of disease activity as measured by numerical disease state score commonly used in clinical practice - to achieve components of the composite primary endpoints - to achieve alternative responder endpoint - to achieve endpoints supporting other key secondary endpoints To evaluate the safety and tolerability of DZP as add-on treatment to SOC medication ;Primary end point(s): Achievement of BICLA response at Week 48 ;Timepoint(s) of evaluation of this end point: Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Achievement of BICLA response at Week 24 2. Achievement of BICLA response at Week 12 3. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48 4. Achievement of LLDAS in =50% of post Baseline visits through Week 48 5. Change from Baseline in SLEDAI-2K at Week 48 6. Achievement of BILAG 2004 improvement without worsening at Week 48 7. Change from Baseline in PGA at Week 48 8. Achievement of SRI 4 response at Week 48 9. Achievement of prevention of moderate/severe BILAG flares (moderate/severe BILAG flarefree) through Week 48 10. Time to severe BILAG flare through Week 48 11. Time to moderate/severe BILAG flare through Week 48 12. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study 13. Percentage of participants with serious treatment-emergent adverse events during the study 14. Percentage of participants with treatment-emergent adverse events of special interest during the study 15. Percentage of participants with treatment-emergent adverse events of special monitoring during the study ;Timepoint(s) of evaluation of this end point: 1: Week 24 2: Week 12 3, 4: During Treatment Period up to Week 48 5: From Baseline (Day 1) to Week 48 6: Week 48 7: From Baseline (Day 1) to Week 48 8: Week 48 9, 10, 11: During Treatment Period up to Week 48 12, 13, 14, 15: From Baseline (Day 1) until Safety Follow-Up (up to Week 54) | — |
Countries
Austria, Belgium, Bulgaria, Canada, China, Czechia, Denmark, France, Germany, Greece, Hong Kong, Italy, Japan, Poland, Portugal, Serbia, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed