Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic, Lupus Vasculitis, Central Nervous System, Lupus Nephritis
Conditions
Keywords
systemic lupus erythematoses, lupus, SLE
Brief summary
Milatuzumab will be given subcutaneously at different dose levels once (depending on the dose level) for 4 weeks to determine if milatuzumab helps to control lupus (SLE).
Detailed description
Milatuzumab or placebo will be given subcutaneously once weekly for 4 weeks to determine if milatuzumab helps to control lupus (SLE). The treatment portion of the study lasts 4 weeks. Then patients are followed for disease activity for at least 12 weeks. If patients respond to the study drug, they may be eligible for one course of retreatment, again followed by 12 weeks of follow-up. Patients who showed a response will continue to be followed at timepoints up to one year after treatment to assess how long the response lasts.
Interventions
DRUGmilatuzumab
Milatuzumab has been used in clinical trials for multiple myeloma, non-Hodgkin's lymphoma and leukemia in the intravenous dosing form. In this study, milatuzumab is being given subcutaneously in patients with lupus.
DRUGPlacebo
Placebo will be administered subcutaneously once weekly for 4 weeks.
Sponsors
United States Department of Defense
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 18 years old * Signed written informed consent before study entry * Diagnosis of SLE by American College of Rheumatology revised criteria (meets ≥ 4 criteria) * Positive ANA (titer ≥ 1:80) at study entry * At least 1 BILAG A or 2 BILAG B scores in any organ/body system and ≥ 6 SELENA-SLEDAI score * Receiving at least 5.0 mg/day oral prednisone (or equivalent) at stable doses for at least 4 weeks prior to study entry * If receiving immunosuppressives or antimalarial agents, at stable doses for at least 4 weeks prior to study entry
Exclusion criteria
* Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test. * Women of childbearing potential and fertile men not practicing or unwilling to practice birth control during the study * Rituximab, belimumab, other prior antibody, investigational or experimental therapy within 6 months * Allergic to murine, chimeric, humanized or human antibodies * Hematologic abnormalities not attributed to lupus: hemoglobin \< 8.0 mg/dL, WBC \< 2000/L, ANC \< 1500/L, platelets \< 50,000/L, * AST, ALT or alkaline phosphatase \> 3 times upper limit of normal and not attributed to lupus * Serum creatinine \> 2.5 mg/dL, proteinuria \> 3.5 g/day * Received live vaccine within 4 weeks * Thrombosis, spontaneous or induced abortion, stillbirth or live birth within 4 weeks * Antiphospholipid antibodies AND a history of thromboembolic events * On oral anticoagulants (not including NSAIDs) within 4 weeks * Active infection with antibiotics within 7 days * Infection requiring hospitalization or herpes zoster treatment within 4 weeks * Long-term infectious diseases (tuberculosis, fungal infections) active within 2 years * Malignancy (except squamous or basal cell carcinoma, cervical CIS) within 3 years (unless approved by the medical monitor) * History of recurrent abortions (2 or more) * Known HIV, hepatitis B or C, other immunosuppressive states * Other concurrent medical conditions that, in the investigator's opinion, could affect the patient's ability to tolerate or complete the study will not be eligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | up to 2 years | Will be assessed using laboratory and clinical data comparing baseline lab results and clinical condition to the lab results and clinical condition/adverse events during treatment and follow-up timepoints up to 2 years. |
| Obtain preliminary evidence of efficacy for patients with active disease. | up to 2 years | Will be assessed using the BILAG scoring model for lupus disease activity and symptoms by comparing baseline BILAG measurements against the BILAG measurements obtained during treatment and during follow-up for up to 2 years. |
Countries
United States
Outcome results
None listed