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Lupus Erythematosus, CutaneousPhase 1NCT01845740

Phase Ib Study of SC Milatuzumab in SLE

A Phase 1 study testing milatuzumab in people with Lupus Erythematosus, Cutaneous and Lupus Erythematosus, Discoid, run by Gilead Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
milatuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
1 siteUnited States
Study dates
Jan 2007to Jun 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cedars Sinai Medical Center-Wallace Rheumatic Study Center

    West Hollywood, California, 90048

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
milatuzumab, Placebo
Keywords
systemic lupus erythematoses, lupus, SLE
Medical subject headings
Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic, Lupus Vasculitis, Central Nervous System, Lupus Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • milatuzumabDrug

    Also called Milatuzumab is a Cd74 targeted humanized monoclonal antibody.

    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.

  • PlaceboDrug

    Placebo will be administered subcutaneously once weekly for 4 weeks.

Study groups in NCT01845740
Study groupRoleWhat they receive
Milatuzumab SC 250 mgExperimentalMilatuzumab 250 mg will be administered subcutaneously once weekly for 4 weeks.
Receives: Drug: milatuzumab
Milatuzumab 150 mg SCExperimentalMilatuzumab 150 mg will be administered subcutaneously once weekly for 4 weeks.
Receives: Drug: milatuzumab
Placebo SCPlacebo comparatorPlacebo will be administered subcutaneously once weekly for 4 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability

    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.

    Measured: up to 2 years

  2. Obtain preliminary evidence of efficacy for patients with active disease.

    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.

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2013 (estimated)
  2. Study startJan 2007
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01845740
Sponsor's protocol ID
IMMU-115-04
Status last verified
Feb 2021
First submitted
17 Apr 2013
Last updated
19 Aug 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22404985

  • 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.

    PubMed 22271448

  • 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.

    PubMed 22042694

  • 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.

    PubMed 1417823

  • 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.

    PubMed 21228331

  • 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.

    PubMed 20574049

  • 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.

    PubMed 19968579

  • 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.

    PubMed 19351768

  • 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.

    PubMed 19053886

  • 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.

    PubMed 17875789

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing milatuzumab in people with Lupus Erythematosus, Cutaneous and Lupus Erythematosus, Discoid, run by Gilead Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01845740, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.

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