Trial · NCT02725515
A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus
NCT02725515, Phase 2, Completed, Xencor, Inc.; results first posted 2019-08-09
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus. Trials, record NCT02725515. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02725515
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus
- NCT number
- NCT02725515
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 105 participants, actual
- Lead sponsor
- Xencor, Inc.
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- XmAb5871, Placebo to match XmAb5871
- First posted
- 2016-04-01
- Last updated
- 2019-08-20
- Results first posted
- 2019-08-09
- Limitations and caveats
Prior to database lock, an evaluation of early discontinuation rates indicated that the efficacy-evaluable population might be insufficient to power the primary analysis. An additional 15 patients were enrolled beyond the originally planned 90.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 |
| Secondary | Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169 | Day 169 | Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 169 |
| Secondary | 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. | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225 | Day 225 | 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) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169 | Day 169 | 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) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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. | 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) | days | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225 | XmAb5871 | 21 | Participants | ||
| Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225 | Placebo | 12 | Participants | ||
| Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169 | XmAb5871 | 29 | Participants | ||
| Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169 | Placebo | 17 | Participants | ||
| Time to Loss of Systemic Lupus Erythematosus Disease Activity Improvement Achieved by a Short Period of IM Steroid Therapy in SLE Patients | XmAb5871 | 230 | 95% Confidence Interval 197.0 to 239.0 | days | |
| Time to Loss of Systemic Lupus Erythematosus Disease Activity Improvement Achieved by a Short Period of IM Steroid Therapy in SLE Patients | Placebo | 131 | 95% Confidence Interval 85.0 to 225.0 | days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | XmAb5871 | 53 | |
| Overall Study | STARTED | Placebo | 52 | |
| Overall Study | COMPLETED | XmAb5871 | 28 | |
| Overall Study | COMPLETED | Placebo | 17 | |
| Overall Study | NOT COMPLETED | XmAb5871 | 25 | |
| Overall Study | NOT COMPLETED | Placebo | 35 |
Source ClinicalTrials.gov
Adverse events82
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | XmAb5871 | 20 | 52 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 9 | 52 | |
| other | Headache | Nervous system disorders | XmAb5871 | 12 | 52 | |
| other | Headache | Nervous system disorders | Placebo | 1 | 52 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | XmAb5871 | 5 | 52 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Placebo | 6 | 52 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | XmAb5871 | 8 | 52 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 2 | 52 | |
| other | Upper respiratory tract infection | Infections and infestations | XmAb5871 | 4 | 52 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 6 | 52 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | XmAb5871 | 0 | 52 |
| Total, all-cause mortality | Placebo | 0 | 52 |
| Total, other adverse events | XmAb5871 | 41 | 52 |
| Total, other adverse events | Placebo | 28 | 52 |
| Total, serious adverse events | XmAb5871 | 7 | 52 |
| Total, serious adverse events | Placebo | 4 | 52 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| XmAb5871 vs Placebo: Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225 | Trial comparisons |
| XmAb5871 vs Placebo: Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169 | Trial comparisons |
| XmAb5871 vs Placebo: deaths from any cause | Trial comparisons |
| XmAb5871 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02725515
GET https://conductscience.org/api/trials/v1/NCT02725515/events?page=2