A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
Study Purpose
The purpose of this study is to 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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 16 Years and Over |
| Gender | All |
Inclusion Criteria:
- - Rescreening will be allowed once during the study in case there is new evidence for an inclusion criterion that was not fulfilled at the first screening or in case a study participant no longer meets an exclusion criterion or screening period exceeded the maximum duration due to delays in screening processes.
- - 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 SLE or due to an acute worsening of SLE in the scope of frequent flaring/relapsing-remitting systemic lupus erythematosus (SLE) despite stable standard of care (SOC) medication defined as: a.
- - Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 at Screening Visit AND.
- - SLEDAI-2K without labs ≥4 at Baseline Visit.
- - Antimalarial treatment in combination with corticosteroids and/or immunosuppressants or as stand-alone treatment if justified OR Treatment with corticosteroids and/or immunosuppressants if anti-malarial treatment is not possible.
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.
- - Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies.
- - Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ, 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 evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection.
- - Study participant had a reactivated latent infection (example, 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 clinically significant active or latent infection.
- - Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE.
- - Study participant takes any protocol defined prohibited concomitant medication.
- - Study participant has previously been randomized within this study or participant has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP.
- - Study participant has participated in another study of an IMP within the previous 12 weeks or 5 half-lives of the investigational medicinal product (IMP) whatever is longer or is currently participating in another study of an IMP.
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04294667 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
UCB Biopharma SRL |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
UCB Cares |
| Principal Investigator Affiliation | 001 844 599 2273 (UCB) |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Active, not recruiting |
| Countries | Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Mexico, Peru, Philippines, Poland, Romania, Serbia, Spain, Taiwan, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Systemic Lupus Erythematosus |
Arms
Experimental: Dapirolizumab pegol
Subjects will receive dapriolizumab pegol througout the Treatment Period.
Placebo Comparator: Placebo
Subjects will receive placebo througout the Treatment Period.
Interventions
Drug: - DZP
Subjects will receive dapirolizumab pegol at prespecified time-points.
Other: - Placebo
Subjects will receive placebo at prespecified time-points.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
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Birmingham, Alabama, 35205
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Phoenix, Arizona, 85032
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Tucson, Arizona, 85704
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Beverly Hills, California, 90211
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La Jolla, California, 92037
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La Palma, California, 90623-1730
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Loma Linda, California, 92354
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Los Angeles, California, 90022
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Orange, California, 92868
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Poway, California, 92064
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San Diego, California, 92108
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San Leandro, California, 94578
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Denver, Colorado, 80230
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New Haven, Connecticut, 06519
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Washington, District of Columbia, 20060
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Brandon, Florida, 33511
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Gainesville, Florida, 32610
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Miami, Florida, 33136
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Ormond Beach, Florida, 32174
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Plantation, Florida, 33324
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Tampa, Florida, 33606
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Tampa, Florida, 33613
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Atlanta, Georgia, 30303
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Atlanta, Georgia, 30309
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Idaho Falls, Idaho, 83404
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Chicago, Illinois, 60612
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Skokie, Illinois, 60076
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Hopkinsville, Kentucky, 42240-1746
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Lake Charles, Louisiana, 70605
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Cumberland, Maryland, 21502
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Hagerstown, Maryland, 21740
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Detroit, Michigan, 48201
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Grand Blanc, Michigan, 48439
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Las Vegas, Nevada, 89128
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New York, New York, 10021
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Syracuse, New York, 13210
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Spokane, Washington, 99204
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Beckley, West Virginia, 25801
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Morgantown, West Virginia, 26505
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