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Trial record 9 of 19 for:    lupus | Open Studies | United States, Kansas | United States, Michigan | United States, Minnesota

Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Seattle Genetics, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc. Identifier:
First received: July 9, 2015
Last updated: September 28, 2016
Last verified: September 2016
The purpose of this study is to evaluate the safety and tolerability of brentuximab vedotin in adults with active systemic lupus erythematosus (SLE).

Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: Brentuximab vedotin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blinded, Placebo-controlled, Multiple-ascending-dose Study of Brentuximab Vedotin in Adults With Active Systemic Lupus Erythematosus

Resource links provided by NLM:

Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Number and percentage of subjects having an Adverse Event [ Time Frame: 127 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of subjects achieving a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) clinical response defined by a ≥ 4 point improvement from baseline [ Time Frame: 85 days ] [ Designated as safety issue: No ]
  • Maximum observed concentration (Cmax) of Brentuximab vedotin and metabolites total antibody (TAb), and monomethyl auristatin E (MMAE) [ Time Frame: Days 1 (pre- and post-dose), 2, 3, 8, 15, 22 (pre- and post-dose), 43 (pre- and post-dose), 64 (pre- and post-dose), 85, 106 and 127 of the study ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve (AUC) of Brentuximab vedotin and metabolites Tab, MMAE [ Time Frame: days 1 (pre- and post-dose), 2, 3, 8, 15, 22 (pre- and post-dose), 43 (pre- and post-dose), 64 (pre- and post-dose), 85, 106 and 127 of the study ] [ Designated as safety issue: No ]
  • Clearance (CL) of Brentuximab vedotin and metabolites Tab, MMAE [ Time Frame: Days 1 (pre- and post-dose), 2, 3, 8, 15, 22 (pre- and post-dose), 43 (pre- and post-dose), 64 (pre- and post-dose), 85, 106 and 127 of the study ] [ Designated as safety issue: No ]
  • Half-life (t1/2); of Brentuximab vedotin and metabolites Tab, MMAE [ Time Frame: Days 1 (pre- and post-dose), 2, 3, 8, 15, 22 (pre- and post-dose), 43 (pre- and post-dose), 64 (pre- and post-dose), 85, 106 and 127 of the study ] [ Designated as safety issue: No ]
  • Incidence of anti-therapeutic antibodies (ATA) [ Time Frame: Days 1, 22, 43, 64, 85, 106 and 107 of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brentuximab vedotin
4 dose groups
Drug: Brentuximab vedotin
Other Name: ADCETRIS (brentuximab vedotin)
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo

Detailed Description:
Systemic lupus erythematosus (SLE) is a chronic, multisystem, disabling autoimmune condition, which predominantly affects women of childbearing years. Treatment options for SLE remain relatively limited. Regardless of the specific therapy chosen, the majority of patients continue to require long term immunomodulatory or cytotoxic therapy, resulting in long-term morbidity and mortality. Brentuximab vedotin is an antibody-drug conjugate (ADC) consisting of: 1) the chimeric immunoglobulin (Ig) G1 antibody cAC10, specific for human CD30, 2) the microtubule disrupting agent monomethyl auristatin E (MMAE), and 3) a protease-cleavable linker that covalently attaches MMAE to cAC10. Since CD30 and/or CD30-expressing immune cells may play significant key roles in the pathogenesis of SLE, brentuximab vedotin may be an efficacious therapy. This study intends to explore the potential for brentuximab vedotin as a therapy for SLE.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults ≥ 18 years
  • Diagnosis of SLE for at least 6 months prior to screening
  • Active SLE as indicated by SLE Disease Activity Index (SLEDAI) ≥ 4 at screening
  • Must have failed a treatment for SLE after a trial of at least 3 months

Exclusion Criteria:

  • The subject has any serious health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study
  • Subject has had recent serious or ongoing infection, or risk for serious infection
  • Subject has a history of new or recurrent malignancy within the past 5 years
  • The subject is pregnant and/or breastfeeding
  • The subject fulfills diagnostic criteria for another rheumatic (overlap) disease that may confound clinical assessments in the study
  • The subject has urgent, severe SLE disease activity, which, in the opinion of the Investigator, warrants immediate immunosuppressive therapy and would not be appropriate 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 identifier: NCT02533570

Contact: Terri Lowe 866-333-7436

United States, Alabama
University of Alabama at Birmingham - (UAB) Recruiting
Birmingham, Alabama, United States, 35294
Contact: Walter Chatham, MD    205-934-4212   
Contact: Cheryl Hardin, RN    205-934-2981   
Principal Investigator: Walter Chatham, MD         
United States, California
Medvin Clinical Research Withdrawn
Covina, California, United States, 91723
TriWest Research Associates, LLC Recruiting
El Cajon, California, United States, 92020-4124
Contact: Arthur Mabaquiao, MD    619-334-4735   
Contact: Diana Banales    619-334-4764 ext 201   
Principal Investigator: Arthur Mabaquiao, MD         
Advanced Medical Research, LLC Recruiting
La Palma, California, United States, 90623
Contact: Gerald Ho, MD    562-867-8195   
Contact: Karim Tasadduq   
Principal Investigator: Gerald Ho, MD         
United States, Colorado
University of Colorado Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Christopher Striebich, MD    303-724-7607   
Contact: Ruth Grosskreuz, MD    303-724-7518   
Principal Investigator: Christopher Striebich, MD         
United States, Florida
Clinical Research of West Florida - Corporate Recruiting
Clearwater, Florida, United States, 33765
Contact: Robert Levin, MD    727-466-0078   
Contact: Margaret Gray, ARNP    727-466-0078 ext 230   
Principal Investigator: Robert Levin, MD         
Lakes Research, LLC Recruiting
Miami Lakes, Florida, United States, 33014
Contact: Benedicto Fernandez, MD    786-362-5763   
Contact: Yamile Sanchez    786-362-5763   
Principal Investigator: Benedicto Fernandez, MD         
Arthritis Associates Recruiting
Orlando, Florida, United States, 32804
Contact: Jeffrey Poiley, MD    407-271-8030   
Contact: Danielle Cortese    407-271-8030   
Principal Investigator: Jeffrey Poiley, MD         
McIlwain Medical Group Recruiting
Tampa, Florida, United States, 33613
Contact: Harris McIlwain, MD    813-345-2380   
Contact: Gretchen Pifer    813-345-2391   
Principal Investigator: Harris McIlwain, MD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Kathleen Maksimowicz-McKinnon, MD    313-916-2631   
Contact: Jenna Hudy    313-916-9328   
Principal Investigator: Kathleen Maksimowicz-McKinnon, MD         
United States, Missouri
Clayton Medical Associates, P.C. Recruiting
St. Louis, Missouri, United States, 63117
Contact: John Budd, MD    314-646-0688   
Contact: Laci Hueffmeier, MA, CCRC    314-646-0688   
Principal Investigator: John Budd, MD         
United States, New York
Weill Cornell Physicians at Brooklyn Heights Not yet recruiting
Brooklyn, New York, United States, 11201
Contact: David Goddard, MD    646-962-4650   
Contact: Debra London    646-962-4681   
Principal Investigator: David Goddard, MD         
United States, North Carolina
DJL Clinical Research, PLLC Recruiting
Charlotte, North Carolina, United States, 28210
Contact: Emily Jane Box, MD    704-247-9179   
Contact: Joe Howe, CRC    704-247-9179 ext 201   
Principal Investigator: Emily Jane Box, MD         
United States, Oklahoma
Arthritis & Rheumatology Center of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73103
Contact: Mohammad Khan, MD    405-606-8730   
Contact: Cheyenne Collins    405-606-8730   
Principal Investigator: Mohammad Khan, MD         
United States, Texas
Tekton Research, Inc. Recruiting
Austin, Texas, United States, 78745
Contact: Paul Pickrell, MD    512-388-5717   
Contact: Marianna Alesi    512-388-5717   
Principal Investigator: Paul Pickrell, MD         
Accurate Clinical Research Recruiting
Houston, Texas, United States, 77034
Contact: Philip Waller, MD    281-481-8557   
Contact: Jeremy Longoria    281-481-8557   
Principal Investigator: Philip Waller, MD         
United States, Virginia
Arthritis Clinic of Northern Virginia, PC Recruiting
Arlington, Virginia, United States, 22205-3606
Contact: Phillip Kempf, MD    703-525-3069   
Contact: Charlene Henderson, RN, BSN    703-300-5483   
Principal Investigator: Phillip Kempf, MD         
Sponsors and Collaborators
Seattle Genetics, Inc.
Study Director: Naomi Hunder, MD Seattle Genetics Medical Monitor
  More Information

Responsible Party: Seattle Genetics, Inc. Identifier: NCT02533570     History of Changes
Other Study ID Numbers: SGN35-022 
Study First Received: July 9, 2015
Last Updated: September 28, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on October 20, 2016