Phase Ib Study of SC Milatuzumab in SLE

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences; Immunomedics, Inc.
• Collaborator: United States Department of Defense

Criteria

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.