Phase Ib Study of SC Milatuzumab in SLE

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Immunomedics, Inc.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT01845740
First received: April 17, 2013
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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: August 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: August 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 ClinicalTrials.gov identifier: NCT01845740

Contacts
Contact: Heather Horne 973-605-8200 ext 173 hhorne@immunomedics.com
Contact: Fran Bozza 973-605-8200 ext 175 fbozza@immunomedics.com

Locations
United States, California
Cedars Sinai Medical Center-Wallace Rheumatic Study Center Not yet recruiting
West Hollywood, California, United States, 90048
Sponsors and Collaborators
Immunomedics, Inc.
Investigators
Principal Investigator: William Wegener, PhD, MD Immunomedics, Inc.
  More Information

Publications:

Responsible Party: Immunomedics, Inc.
ClinicalTrials.gov Identifier: NCT01845740     History of Changes
Other Study ID Numbers: IMMU-115-04
Study First Received: April 17, 2013
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Immunomedics, Inc.:
systemic lupus erythematoses
lupus
SLE

Additional relevant MeSH terms:
Lupus Erythematosus, Discoid
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Systemic
Lupus Nephritis
Nephritis
Vasculitis
Vasculitis, Central Nervous System
Lupus Vasculitis, Central Nervous System
Connective Tissue Diseases
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Meningoencephalitis
Encephalitis
Central Nervous System Infections
Meningitis
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014