Status:
COMPLETED
Phase Ib Study of SC Milatuzumab in SLE
Lead Sponsor:
Gilead Sciences
Collaborating Sponsors:
United States Department of Defense
Conditions:
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Discoid
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01845740
Start Date
January 1 2007
End Date
June 1 2009
Last Update
August 19 2021
Active Locations (1)
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1
Cedars Sinai Medical Center-Wallace Rheumatic Study Center
West Hollywood, California, United States, 90048