Phase Ib Study of SC Milatuzumab in SLE

Completed · Phase 1 · Has a placebo group

Conditions studied: Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic, Lupus Vasculitis, Central Nervous System, Lupus Nephritis

In brief

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).

Key facts

Study ID

NCT01845740

Run by

Gilead Sciences

People needed

22

Starts

2007-01-01

Expected to finish

2009-06-01

Last updated by the study team

2021-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Cedars Sinai Medical Center-Wallace Rheumatic Study Center — West Hollywood, California, United States

Full record on ClinicalTrials.gov

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