Trial record 9 of 16 for:    lupus | Open Studies | United States, Kansas | United States, Michigan | United States, Minnesota

A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Xencor, Inc.
Sponsor:
Collaborators:
PPD
ICON plc
Information provided by (Responsible Party):
Xencor, Inc.
ClinicalTrials.gov Identifier:
NCT02725515
First received: January 8, 2016
Last updated: July 15, 2016
Last verified: July 2016
  Purpose
The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus Erythematosus (SLE) disease activity improvement achieved by a brief course of disease-suppressing steroid therapy

Condition Intervention Phase
Systemic Lupus Erythematosus
Biological: XmAb5871
Biological: Placebo to match XmAb5871
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease Activity

Resource links provided by NLM:


Further study details as provided by Xencor, Inc.:

Primary Outcome Measures:
  • Percentage of patients without loss of systemic lupus erythematosus disease activity improvement on Day 169 [ Time Frame: Day 169 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to loss of systemic lupus erythematosus disease activity improvement achieved by a short intramuscular injection steroid therapy [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
  • Number of participants who experience Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) as assessed by CTCAE v4.3 [ Time Frame: Day 197 ] [ Designated as safety issue: Yes ]
  • Percentage of participants who experience Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) as assessed by CTCAE v4.3 [ Time Frame: Day 197 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: February 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XmAb5871
XmAb5871 administered by IV infusion for up to a total of 12 infusions
Biological: XmAb5871
Placebo Comparator: Placebo
Placebo to match XmA5871 administered by IV infusion for up to a total of 12 infusions
Biological: Placebo to match XmAb5871

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of SLE as defined by the ACR criteria
  • Patients have a history of a (+) ANA, (+) ENA or a (+) anti-dsDNA serology documented within one year prior to randomization
  • Investigator has assessed the patient and in their judgment, the SLE disease activity is not organ threatening
  • Both investigator and patient agree that it is acceptable to discontinue their current immunosuppressant SLE medications and receive a brief course of IM steroid therapy
  • If patients are on oral steroids, they must be on the equivalent of ≤15 mg/day of prednisone to enter screening, and must be able to taper to ≤10 mg/day by randomization

Exclusion Criteria:

  • History or evidence of a clinically unstable/uncontrolled disorder, condition or disease, other than SLE that, in the opinion of the investigator would pose a risk to patient safety or interfere with the study evaluation, procedures or completion
  • Patients who have organ threatening manifestations of SLE including active Class 3 or 4 lupus nephritis requiring induction or maintenance therapy or any other disorder for which stopping SLE therapy is contraindicated
  • Active CNS lupus such as seizures or psychosis that in the opinion of the investigator would preclude participation
  • Unstable hemolytic anemia or thrombocytopenia
  • Patient is pregnant or breast feeding, or planning to become pregnant while participating in the study
  • Use of any biologic therapy (including belimumab) within 6 months of randomization, or prior exposure to a monoclonal antibody directed to CD20 (such as rituximab) within 12 months of randomization
  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: NCT02725515

Contacts
Contact: Debra Zack, MD 858-480-3893 dzack@xencor.com
Contact: Steve DeMattos, BS 858-480-3892 sdemattos@xencor.com

Locations
United States, California
UC San Diego Recruiting
La Jolla, California, United States, 92037
East Bay Rheumatology Medical Group Recruiting
San Leandro, California, United States, 94578
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Center For Rheumatology Recruiting
Fort Lauderdale, Florida, United States, 33309
United States, Georgia
Piedmont Atlanta Rheumatology Recruiting
Atlanta, Georgia, United States, 30309
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Michigan
Fiechtner Research Inc. Recruiting
Lansing, Michigan, United States, 48910
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
United States, New York
Suny Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Feinstein Institute for Medical Research Recruiting
Manhasset, New York, United States, 11030
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
United States, North Carolina
CTRC University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27517
DJL Clinical Research Recruiting
Charlotte, North Carolina, United States, 28210
United States, Ohio
Paramount Medical Research and Consulting LLC Recruiting
Cleveland, Ohio, United States, 44130
United States, Oklahoma
Arthritis & Rheumatology Center of Oklahoma, PLLC Recruiting
Oklahoma City, Oklahoma, United States, 73103
Oklahoma Center for Arthritis Therapy & Research Recruiting
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Altoona Center for Clinical Research Recruiting
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
Xencor, Inc.
PPD
ICON plc
  More Information

Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT02725515     History of Changes
Other Study ID Numbers: XmAb5871-04 
Study First Received: January 8, 2016
Last Updated: July 15, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2016