Phase Ib Study of SC Milatuzumab in SLE

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Immunomedics, Inc.
Department of Defense
Information provided by (Responsible Party):
Immunomedics, Inc. Identifier:
First received: April 17, 2013
Last updated: January 12, 2015
Last verified: January 2015

Milatuzumab will be given subcutaneously at different dose levels once or twice weekly (depending on the dose level) for 4 weeks to determine if milatuzumab helps to control lupus (SLE).

Condition Intervention Phase
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Discoid
Lupus Erythematosus, Systemic
Lupus Vasculitis, Central Nervous System
Lupus Nephritis
Drug: milatuzumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib Study of Milatuzumab Administered Subcutaneously in Patients With Active Systemic Lupus Erythematosus (SLE)

Resource links provided by NLM:

Further study details as provided by Immunomedics, Inc.:

Primary Outcome Measures:
  • safety [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    Safety of the subcutaneously administered milatuzumab 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.

  • Efficacy [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Efficacy 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.

Estimated Enrollment: 30
Study Start Date: January 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Milatuzumab SC
Milatuzumab is the study drug that will be administered subcutaneously at 3 different dose levels once or twice 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 Name: Milatuzumab is a Cd74 targeted humanized monoclonal antibody.

Detailed Description:

Milatuzumab will be given subcutaneously at different dose levels once or twice weekly (depending on the dose level) 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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 2 BILAG B scores (but no A's) in any organ/body system
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01845740

Contact: Heather Horne 973-605-8200 ext 173
Contact: Fran Bozza 973-605-8200 ext 175

United States, California
Cedars Sinai Medical Center-Wallace Rheumatic Study Center Recruiting
West Hollywood, California, United States, 90048
Contact: Florence Figeruas    310-360-9197   
Sponsors and Collaborators
Immunomedics, Inc.
Department of Defense
Principal Investigator: William Wegener, PhD, MD Immunomedics, Inc.
  More Information


Responsible Party: Immunomedics, Inc. Identifier: NCT01845740     History of Changes
Other Study ID Numbers: IMMU-115-04
Study First Received: April 17, 2013
Last Updated: January 12, 2015
Health Authority: United States: Food and Drug Administration
US Department of Defense

Keywords provided by Immunomedics, Inc.:
systemic lupus erythematoses

Additional relevant MeSH terms:
Lupus Erythematosus, Discoid
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Systemic
Lupus Nephritis
Lupus Vasculitis, Central Nervous System
Vasculitis, Central Nervous System
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Central Nervous System Infections
Cerebrovascular Disorders
Connective Tissue Diseases
Immune System Diseases
Kidney Diseases
Nervous System Diseases
Skin Diseases
Urologic Diseases
Vascular Diseases processed this record on October 02, 2015