Trial Outcomes & Findings for A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus (NCT NCT02725515)

NCT ID: NCT02725515

Last Updated: 2019-08-20

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

105 participants

Primary outcome timeframe

Day 225

Results posted on

2019-08-20

Participant Flow

First informed consent date: 16FEB2016 First randomization date: 07MAR2016 Last informed consent date: 09NOV2017 Last randomization date: 07DEC2017

After obtaining informed consent, IM depomedrol was administered and screening studies were performed over the 2-4 week screening period. Immunosuppressive therapy must have been stopped or tapered off by randomization on Day 1. Patients who did not meet the disease activity improvement criteria during the screening period were not randomized.

Participant milestones

Participant milestones
Measure	XmAb5871 XmAb5871 administered by IV infusion for up to a total of 16 infusions	Placebo Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions
Overall Study STARTED	53	52
Overall Study COMPLETED	28	17
Overall Study NOT COMPLETED	25	35

Reasons for withdrawal

Reasons for withdrawal
Measure	XmAb5871 XmAb5871 administered by IV infusion for up to a total of 16 infusions	Placebo Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions
Overall Study Refused infusion (no study treatment)	1	0
Overall Study Loss of Improvement per Protocol	14	25
Overall Study Withdrawal by Subject	2	1
Overall Study Non-Compliance With Study Drug	0	3
Overall Study Lost to Follow-up	1	1
Overall Study Adverse Event	7	2
Overall Study No Documented Disease Improvement	0	1
Overall Study Completed Study Under Original Protocol	0	1
Overall Study Lack of Response	0	1

Baseline Characteristics

Efficacy Evaluable Population: All patients who: * Complete study through Day 225 assessments * Discontinue due to reaching the protocol specified LOI endpoint (and have not missed 2 or more consecutive doses prior to the LOI visit) * Discontinue due to drug-related adverse event (nonresponder)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	XmAb5871 n=52 Participants XmAb5871 administered by IV infusion for up to a total of 16 infusions	Placebo n=52 Participants Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions	Total n=104 Participants Total of all reporting groups
Age, Continuous	45.5 years n=52 Participants	43.5 years n=52 Participants	45.0 years n=104 Participants
Sex: Female, Male Female	50 Participants n=52 Participants	49 Participants n=52 Participants	99 Participants n=104 Participants
Sex: Female, Male Male	2 Participants n=52 Participants	3 Participants n=52 Participants	5 Participants n=104 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=52 Participants	4 Participants n=52 Participants	10 Participants n=104 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=52 Participants	48 Participants n=52 Participants	94 Participants n=104 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=52 Participants	0 Participants n=52 Participants	0 Participants n=104 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=52 Participants	1 Participants n=52 Participants	3 Participants n=104 Participants
Race (NIH/OMB) Asian	2 Participants n=52 Participants	1 Participants n=52 Participants	3 Participants n=104 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=52 Participants	0 Participants n=52 Participants	0 Participants n=104 Participants
Race (NIH/OMB) Black or African American	26 Participants n=52 Participants	25 Participants n=52 Participants	51 Participants n=104 Participants
Race (NIH/OMB) White	19 Participants n=52 Participants	25 Participants n=52 Participants	44 Participants n=104 Participants
Race (NIH/OMB) More than one race	0 Participants n=52 Participants	0 Participants n=52 Participants	0 Participants n=104 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=52 Participants	0 Participants n=52 Participants	3 Participants n=104 Participants
Region of Enrollment United States	52 participants n=52 Participants	52 participants n=52 Participants	104 participants n=104 Participants
SLEDAI Total Score at Screening--Efficacy Evaluable Population	8.0 units on a scale n=50 Participants • Efficacy Evaluable Population: All patients who: * Complete study through Day 225 assessments * Discontinue due to reaching the protocol specified LOI endpoint (and have not missed 2 or more consecutive doses prior to the LOI visit) * Discontinue due to drug-related adverse event (nonresponder)	10.0 units on a scale n=42 Participants • Efficacy Evaluable Population: All patients who: * Complete study through Day 225 assessments * Discontinue due to reaching the protocol specified LOI endpoint (and have not missed 2 or more consecutive doses prior to the LOI visit) * Discontinue due to drug-related adverse event (nonresponder)	10.0 units on a scale n=92 Participants • Efficacy Evaluable Population: All patients who: * Complete study through Day 225 assessments * Discontinue due to reaching the protocol specified LOI endpoint (and have not missed 2 or more consecutive doses prior to the LOI visit) * Discontinue due to drug-related adverse event (nonresponder)

PRIMARY outcome

Timeframe: Day 225

Population: Efficacy Evaluable Population: All patients who: * Complete study through Day 225 assessments * Discontinue due to reaching the protocol specified LOI endpoint (and have not missed 2 or more consecutive doses prior to the LOI visit) * Discontinue due to drug-related adverse event (nonresponder)

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

Outcome measures

Outcome measures
Measure	XmAb5871 n=50 Participants XmAb5871 administered by IV infusion for up to a total of 16 infusions	Placebo n=42 Participants Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions
Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225	21 Participants	12 Participants

SECONDARY outcome

Timeframe: Day 169

Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 169

Outcome measures

Outcome measures
Measure	XmAb5871 n=50 Participants XmAb5871 administered by IV infusion for up to a total of 16 infusions	Placebo n=42 Participants Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions
Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169	29 Participants	17 Participants

SECONDARY outcome

Timeframe: 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.

Loss of improvement was defined as worsening of disease activity that in the opinion of the principal investigator requires a change in treatment (exclusive of a decrease in oral steroids) AND one of: 1. SELENA- SLEDAI increase of \>=4 points from maximal improvement OR 2. Worsening of at least 1 BILAG A or B score OR 3. New BILAG A or B score.

Outcome measures

Outcome measures
Measure	XmAb5871 n=50 Participants XmAb5871 administered by IV infusion for up to a total of 16 infusions	Placebo n=42 Participants Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions
Time to Loss of Systemic Lupus Erythematosus Disease Activity Improvement Achieved by a Short Period of IM Steroid Therapy in SLE Patients	230 days Interval 197.0 to 239.0	131 days Interval 85.0 to 225.0

Adverse Events

XmAb5871

Serious events: 7 serious events

Other events: 41 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	XmAb5871 n=52 participants at risk XmAb5871 administered by IV infusion for up to a total of 16 infusions	Placebo n=52 participants at risk Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions
Blood and lymphatic system disorders Iron deficiency anaemia	1.9% 1/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.	0.00% 0/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.
Blood and lymphatic system disorders Anaemia	0.00% 0/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.	1.9% 1/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.
Cardiac disorders Atrial fibrillation	1.9% 1/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.	0.00% 0/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.
Gastrointestinal disorders Enteritis	0.00% 0/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.	1.9% 1/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.
General disorders Pyrexia	1.9% 1/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.	0.00% 0/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.
Infections and infestations Pneumonia	1.9% 1/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.	0.00% 0/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.
Injury, poisoning and procedural complications Infusion related reaction	1.9% 1/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.	0.00% 0/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	1.9% 1/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.	1.9% 1/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.
Nervous system disorders Migraine	0.00% 0/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.	1.9% 1/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.
Nervous system disorders Dizziness	1.9% 1/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.	0.00% 0/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.	1.9% 1/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.
Vascular disorders Hypertension	1.9% 1/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.	0.00% 0/52 • Adverse event summaries include events reported between randomization and the end of study visit (Day 253) Adverse events were reported by study center investigators using an electronic data capture system. Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.

Other adverse events

Additional Information

Vice President, Biometrics

Xencor, Inc.

Phone: 858-480-3414

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place