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Phase Ib Study of SC Milatuzumab in SLE

This study is currently recruiting participants.
Verified October 2015 by Immunomedics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01845740
First Posted: May 3, 2013
Last Update Posted: October 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Immunomedics, Inc.
  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
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)

Resource links provided by NLM:


Further study details as provided by Immunomedics, Inc.:

Primary Outcome Measures:
  • safety [ Time Frame: up to 2 years ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Frölich D, Blassfeld D, Reiter K, Giesecke C, Daridon C, Mei HE, Burmester GR, Goldenberg DM, Salama A, Dörner T. The anti-CD74 humanized monoclonal antibody, milatuzumab, which targets the invariant chain of MHC II complexes, alters B-cell proliferation, migration, and adhesion molecule expression. Arthritis Res Ther. 2012 Mar 9;14(2):R54. doi: 10.1186/ar3767.
Gupta P, Goldenberg DM, Rossi EA, Cardillo TM, Byrd JC, Muthusamy N, Furman RR, Chang CH. Dual-targeting immunotherapy of lymphoma: potent cytotoxicity of anti-CD20/CD74 bispecific antibodies in mantle cell and other lymphomas. Blood. 2012 Apr 19;119(16):3767-78. doi: 10.1182/blood-2011-09-381988. Epub 2012 Jan 23.
Alinari L, Mahoney E, Patton J, Zhang X, Huynh L, Earl CT, Mani R, Mao Y, Yu B, Quinion C, Towns WH, Chen CS, Goldenberg DM, Blum KA, Byrd JC, Muthusamy N, Praetorius-Ibba M, Baiocchi RA. FTY720 increases CD74 expression and sensitizes mantle cell lymphoma cells to milatuzumab-mediated cell death. Blood. 2011 Dec 22;118(26):6893-903. doi: 10.1182/blood-2011-06-363879. Epub 2011 Oct 31.
Santana JM, Grellier P, Rodier MH, Schrevel J, Teixeira A. Purification and characterization of a new 120 kDa alkaline proteinase of Trypanosoma cruzi. Biochem Biophys Res Commun. 1992 Sep 30;187(3):1466-73.
Alinari L, Yu B, Christian BA, Yan F, Shin J, Lapalombella R, Hertlein E, Lustberg ME, Quinion C, Zhang X, Lozanski G, Muthusamy N, Prætorius-Ibba M, O'Connor OA, Goldenberg DM, Byrd JC, Blum KA, Baiocchi RA. Combination anti-CD74 (milatuzumab) and anti-CD20 (rituximab) monoclonal antibody therapy has in vitro and in vivo activity in mantle cell lymphoma. Blood. 2011 Apr 28;117(17):4530-41. doi: 10.1182/blood-2010-08-303354. Epub 2011 Jan 12.
Hertlein E, Triantafillou G, Sass EJ, Hessler JD, Zhang X, Jarjoura D, Lucas DM, Muthusamy N, Goldenberg DM, Lee RJ, Byrd JC. Milatuzumab immunoliposomes induce cell death in CLL by promoting accumulation of CD74 on the surface of B cells. Blood. 2010 Oct 7;116(14):2554-8. doi: 10.1182/blood-2009-11-253203. Epub 2010 Jun 23.
Berkova Z, Tao RH, Samaniego F. Milatuzumab - a promising new immunotherapeutic agent. Expert Opin Investig Drugs. 2010 Jan;19(1):141-9. doi: 10.1517/13543780903463854. Review.
Stein R, Smith MR, Chen S, Zalath M, Goldenberg DM. Combining milatuzumab with bortezomib, doxorubicin, or dexamethasone improves responses in multiple myeloma cell lines. Clin Cancer Res. 2009 Apr 15;15(8):2808-17. doi: 10.1158/1078-0432.CCR-08-1953. Epub 2009 Apr 7.
Mark T, Martin P, Leonard JP, Niesvizky R. Milatuzumab: a promising new agent for the treatment of lymphoid malignancies. Expert Opin Investig Drugs. 2009 Jan;18(1):99-104. doi: 10.1517/13543780802636162 . Review.
Stein R, Mattes MJ, Cardillo TM, Hansen HJ, Chang CH, Burton J, Govindan S, Goldenberg DM. CD74: a new candidate target for the immunotherapy of B-cell neoplasms. Clin Cancer Res. 2007 Sep 15;13(18 Pt 2):5556s-5563s. Review.

Responsible Party: Immunomedics, Inc.
ClinicalTrials.gov Identifier: NCT01845740     History of Changes
Other Study ID Numbers: IMMU-115-04
First Submitted: April 17, 2013
First Posted: May 3, 2013
Last Update Posted: October 5, 2015
Last Verified: October 2015

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

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Nephritis
Vasculitis
Lupus Nephritis
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Discoid
Vasculitis, Central Nervous System
Lupus Vasculitis, Central Nervous System
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases
Glomerulonephritis
Skin Diseases
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Meningoencephalitis
Encephalitis
Central Nervous System Viral Diseases
Central Nervous System Infections
Meningitis


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