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Trial record 12 of 18 for:    Vasculitis | Open Studies | NIH, U.S. Fed

Phase Ib Study of SC Milatuzumab in SLE

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Immunomedics, Inc.
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT01845740
First received: April 17, 2013
Last updated: October 1, 2015
Last verified: October 2015
  Purpose
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 Intervention Phase
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Discoid
Lupus Erythematosus, Systemic
Lupus Vasculitis, Central Nervous System
Lupus Nephritis
Drug: milatuzumab
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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 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 Name: 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 Name: 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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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.
  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

Locations
United States, California
Cedars Sinai Medical Center-Wallace Rheumatic Study Center Recruiting
West Hollywood, California, United States, 90048
Contact: Florence Figeruas    310-360-9197    ffigueras@wallacemedical.com   
Sponsors and Collaborators
Immunomedics, Inc.
United States Department of Defense
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: October 1, 2015
Health Authority: United States: Food and Drug Administration
United States: Department of Defense

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

Additional relevant MeSH terms:
Vasculitis
Vasculitis, Central Nervous System
Lupus Vasculitis, Central Nervous System
Lupus Erythematosus, Systemic
Lupus Nephritis
Nephritis
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Discoid
Connective Tissue 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
Skin Diseases
Meningoencephalitis
Encephalitis
Central Nervous System Viral Diseases
Central Nervous System Infections
Meningitis

ClinicalTrials.gov processed this record on December 02, 2016