Institutional Review Board, Hospital for Special Surgery
June 01, 2021
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
David R. Fernandez, MD,PhD
The purpose of this study is to evaluate the investigational drug Dapirolizumab Pegol in order to identify safety and efficacy of the drug for the treatment of active Systemic Lupus Erythematosus (SLE) in patients who are not responding to standard therapy. Dapirolizumab pegol is an antibody that targets CD40 ligand (CD40L), a protein in your immune system that affects T cell and B cell activity. Previous studies have shown that blocking CD40L is efficacious in treatment of inflammatory and autoimmune conditions. The results of early clinical studies have shown support for the use of Dapirolizumab Pegol for treatment of SLE.
Approximately 450 patients will be enrolled into this study worldwide, about 2 of whom will be at Hospital for Special Surgery. Study subjects who meet the study’s eligibility requirements and are enrolled will be randomized to receive either dapirolizumab pegol or placebo in a ratio of 2:1. Treatment will be administered every month via intravenous infusion, with the last dose at Week 48. Study duration for a single subject will be 48 weeks plus a 2-week screening period and a 6-week safety follow-up period. The research staff will provide a schedule of assessments that illustrates when study subjects will be expected to attend study visits.
Someone can participate in this study if they meet ALL of the following:
• At least 16 years of age and able to provide informed consent (if 16-17 years of age, then must be accompanied by a parent or guardian)
• SLE fulfilling 2019 EULAR/ACR criteria
• Moderate to severe SLE disease activity as defined by the SLEDAI-2K and BILAG 2004 assessments
o Serological evidence for SLE at screening visit
• Taking standard of care medications for minimal lengths of time and without changes in dose for at least 8-12 weeks
o Antimalarial treatment with corticosteroids and/or immunosuppressants
o Treatment with corticosteroids and/or immunosuppressants if antimalarial treatment is not possible
o ≤ 40 mg/day prednisone or other equivalent oral corticosteroid, stable ≥ 2 weeks prior to screening
Someone cannot participate in this study if they have ANY of the following:
• History of anaphylaxis to latex, contrast agents, antibodies, or other human or murine proteins. Or, allergy/hypersensitivity to any components of Dapirolizumab Pegol including pegol or comparative drugs
• Another medical or psychiatric condition (including neuropsychiatric SLE and infections) that may confound SLE disease assessment and/or poses a danger to the participant
• Any cancer except the following treated cancers: cervical carcinoma, basal cell carcinoma, or dermatological squamous cell carcinoma
• Major surgery within 24 weeks prior to screening
• Significant blood loss or have donated/received ≥450 mL of blood within 30 days of screening
• History of thromboembolic events within 52 weeks of screening
• Mixed connective tissue disease, scleroderma, and/or overlap of these diseases with SLE
• Excluded medication therapy:
o Needing SOC treatment exceeding that permitted by the study
o Rituximab, Ofatumumab, Obinutuzimab, Ocrelizumab, Veltruzumab within 12 months
o Cyclophosphamide, Vedolizumab, Ustekinumab, BIIB059 within 6 months
o Belimumab, Tabalumab, Anifrolumab, Sifalimumab within 4 months
o Abatacept, Eculizumab, ETI-201, Natalizumab, TACI-Ig, Tocilizumab, Rigerimod within 3 months
o Tacrolimus, Pimecrolimus, Sirolimus, IV IG, Minocycline, JAK inhibitors, TYK 2 inhibitors within 4 weeks
• Other investigational drug within 3 months of screening or within 5 half-lives of the last dose
• Received or plan to receive a live vaccine 6 weeks prior to/during the study
• Pregnant, planning to become pregnant, unwilling to use contraception through study and for 17 weeks after end of treatment in the study, or breastfeeding