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XmAb5871

Phase 2

Systemic Lupus Erythematosus | Monoclonal antibody | Immunology |Xencor, Inc.|Last Updated: Aug 20, 2019

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment105
FDA Designations
No designations recorded
Clinical trial landscape

XmAb5871 · 3 trials · 3 indications

Phase 2 2Phase 1 1
NCT02725476Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD)IgG4-RD
COMPLETED20 Analytics
NCT02725515A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus ErythematosusSystemic Lupus Erythematosus
COMPLETED105 Analytics
PHASE2COMPLETED
Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD)
IgG4-RD
NCT0272547620
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PHASE2COMPLETED
A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
NCT02725515105
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Study Endpoints
Primary Endpoints
Proportion of Patients With an Improvement in IgG4-RD Activity
Baseline Day 1 to Day 169

Improvement of disease activity as defined by a decrease of IgG4-RD responder index \>= 2 points from Day 1 pre-dose disease activity score. The IgG4-RD Responder Index Total Activity Score ranges from 0 to a maximum of 162. Higher scores represent greater (i.e. worse) disease activity. A score of 0 represents no disease activity other than residual fibrosis.

Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225
Day 225

Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 225

Cmax, Maximum observed serum concentration
Date of enrollment to Day 57
Tmax, Time of maximum observed serum concentration
Date of enrollment to Day 57
AUC, Area under the plasma concentration versus time curve
Date of enrollment to Day 57
CL, Clearance of drug from the body
Date of enrollment to Day 57
Vz, Volume of distribution
Date of enrollment to Day 57
F, bioavailability of a SC dose relative to an IV dose
Date of enrollment to Day 57
Number of participants with adverse events that are related to treatment
Date of enrollment to Day 57
Number of participants with severe adverse events that are related to treatment
Date of enrollment to Day 57
Number of participants with abnormal laboratory values related to treatment
Date of enrollment to Day 57
Number of participants with abnormal ECGs related to treatment
Date of enrollment to Day 57
Secondary Endpoints
Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3
Baseline Day 1 to Day 197
Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169
Day 169
Time to Loss of Systemic Lupus Erythematosus Disease Activity Improvement Achieved by a Short Period of IM Steroid Therapy in SLE Patients
From the date of randomization until the date of loss of Systemic Lupus Erythematosus Disease Activity Improvement, or the date of the final efficacy assessment, up to 239 days.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
XmAb5871EXPERIMENTALXmAb5871 administered by IV infusion for up to a total of 12 infusions
PlaceboPLACEBO_COMPARATORPlacebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions
Cohort 1EXPERIMENTALDose Level 1 XmAb5871 given SC Q14days X 3
Cohort 2EXPERIMENTALDose Level 2 XmAb5871 given SC Q14days X 3
Cohort 3EXPERIMENTALDose Level 3 XmAb5871 given SC Q14days X 3
Cohort 4EXPERIMENTALDose Level 4 XmAb5871 given IV Q14days X 3
Cohort 5EXPERIMENTALDose Level 5 XmAb5871 given SC Q7days X 3
Interventions
NameTypeDescription
XmAb5871BIOLOGICAL -
Placebo to match XmAb5871BIOLOGICAL -
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Eligibility Criteria
Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Active IgG4-RD * Compatible pattern of organ involvement consistent with IgG4-RD that cannot be attributed to other causes * Histopathologically-proven diagnosis of IgG4-RD * Peripheral blood plasmablast count \>900 cells/mL and/or elevated IgG4-RD levels during screening * Ab...

Countries:United States
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Competitive Landscape -Systemic Lupus Erythematosus 94 trials

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