- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01845740
Phase Ib Study of SC Milatuzumab in SLE
August 12, 2021 updated by: Gilead Sciences
A Phase Ib Study of Milatuzumab Administered Subcutaneously in Patients With Active Systemic Lupus Erythematosus (SLE)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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West Hollywood, California, United States, 90048
- Cedars Sinai Medical Center-Wallace Rheumatic Study Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Milatuzumab SC 250 mg
Milatuzumab 250 mg will be administered subcutaneously once weekly for 4 weeks.
|
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:
|
EXPERIMENTAL: Milatuzumab 150 mg SC
Milatuzumab 150 mg will be administered subcutaneously once weekly for 4 weeks.
|
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:
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PLACEBO_COMPARATOR: Placebo SC
Placebo will be administered subcutaneously once weekly for 4 weeks.
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Placebo will be administered subcutaneously once weekly for 4 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability
Time Frame: up to 2 years
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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.
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up to 2 years
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Obtain preliminary evidence of efficacy for patients with active disease.
Time Frame: up to 2 years
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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.
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up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: William Wegener, PhD, MD, Gilead Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1158/1078-0432.CCR-07-1167.
- Frolich D, Blassfeld D, Reiter K, Giesecke C, Daridon C, Mei HE, Burmester GR, Goldenberg DM, Salama A, Dorner 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. doi: 10.1016/0006-291x(92)90467-y.
- Alinari L, Yu B, Christian BA, Yan F, Shin J, Lapalombella R, Hertlein E, Lustberg ME, Quinion C, Zhang X, Lozanski G, Muthusamy N, Praetorius-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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2007
Primary Completion (ACTUAL)
June 1, 2009
Study Completion (ACTUAL)
June 1, 2009
Study Registration Dates
First Submitted
April 17, 2013
First Submitted That Met QC Criteria
May 1, 2013
First Posted (ESTIMATE)
May 3, 2013
Study Record Updates
Last Update Posted (ACTUAL)
August 19, 2021
Last Update Submitted That Met QC Criteria
August 12, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Skin Diseases
- Infections
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Kidney Diseases
- Urologic Diseases
- Connective Tissue Diseases
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Glomerulonephritis
- Meningoencephalitis
- Encephalitis
- Meningitis
- Lupus Erythematosus, Systemic
- Nephritis
- Lupus Nephritis
- Vasculitis
- Lupus Vasculitis, Central Nervous System
- Lupus Erythematosus, Cutaneous
- Lupus Erythematosus, Discoid
- Vasculitis, Central Nervous System
Other Study ID Numbers
- IMMU-115-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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