Phase Ib Study of SC Milatuzumab in SLE

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT01845740

Collaborator

United States Department of Defense (U.S. Fed)

Enrollment

Location

Arms

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Lupus Erythematosus, Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus, Systemic Lupus Vasculitis, Central Nervous System Lupus Nephritis	Drug: milatuzumab Drug: Placebo	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase Ib Study of Milatuzumab Administered Subcutaneously in Patients With Active Systemic Lupus Erythematosus (SLE)

Actual Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Milatuzumab SC 250 mg Milatuzumab 250 mg will be administered subcutaneously once weekly for 4 weeks.	Drug: milatuzumab 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. Other Names: Milatuzumab is a Cd74 targeted humanized monoclonal antibody.
Experimental: Milatuzumab 150 mg SC Milatuzumab 150 mg will be administered subcutaneously once weekly for 4 weeks.	Drug: milatuzumab 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. Other Names: Milatuzumab is a Cd74 targeted humanized monoclonal antibody.
Placebo Comparator: Placebo SC Placebo will be administered subcutaneously once weekly for 4 weeks.	Drug: Placebo Placebo will be administered subcutaneously once weekly for 4 weeks.

Arm

Intervention/Treatment

Experimental: Milatuzumab SC 250 mg

Milatuzumab 250 mg will be administered subcutaneously once weekly for 4 weeks.

Drug: milatuzumab

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.

Other Names:

Milatuzumab is a Cd74 targeted humanized monoclonal antibody.

Experimental: Milatuzumab 150 mg SC

Milatuzumab 150 mg will be administered subcutaneously once weekly for 4 weeks.

Drug: milatuzumab

Other Names:

Milatuzumab is a Cd74 targeted humanized monoclonal antibody.

Placebo Comparator: Placebo SC

Placebo will be administered subcutaneously once weekly for 4 weeks.

Drug: Placebo

Placebo will be administered subcutaneously once weekly for 4 weeks.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.