Trial · NCT02725476

Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD)

NCT02725476, Phase 2, Completed, Xencor, Inc.; results first posted 2018-12-07

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD). Trials, record NCT02725476. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02725476

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD)
NCT number: NCT02725476
Status: Completed
Phases: Phase 2
Enrollment: 20 participants, actual
Lead sponsor: Xencor, Inc.
Conditions: IgG4-RD
Interventions: XmAb5871
First posted: 2016-04-01
Last updated: 2018-12-07
Results first posted: 2018-12-07
Limitations and caveats: The fixed-dose group was added by amendment to collect information on fixed IV doses with bioequivalence to subcutaneous doses planned for future studies. This group is not intended for efficacy or safety comparisons to the initial 15 participants.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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.
Secondary	Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3	Baseline Day 1 to Day 197	The number of patients experiencing a treatment-emergent adverse event as assessed by CTCAE v4.3 will be tabulated according to MedDRA system-organ class and preferred term, intensity and causality.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Patients With an Improvement in IgG4-RD Activity	Baseline Day 1 to Day 169	Intent to Treat (ITT) Population: All patients who have received at least a partial dose of XmAb5871.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3	Baseline Day 1 to Day 197	Safety Population: All patients who receive at least a partial dose of XmAb5871.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Proportion of Patients With an Improvement in IgG4-RD Activity	XmAb5871 5 mg/kg	Responder at Day 169 visit	12	Participants
Proportion of Patients With an Improvement in IgG4-RD Activity	XmAb5871 Fixed Dose	Responder at Day 169 visit	4	Participants
Proportion of Patients With an Improvement in IgG4-RD Activity	XmAb5871 5 mg/kg	Non-Responder at Day 169 visit	2	Participants
Proportion of Patients With an Improvement in IgG4-RD Activity	XmAb5871 Fixed Dose	Non-Responder at Day 169 visit	0	Participants
Proportion of Patients With an Improvement in IgG4-RD Activity	XmAb5871 5 mg/kg	Not Assessed at Day 169 visit	1	Participants
Proportion of Patients With an Improvement in IgG4-RD Activity	XmAb5871 Fixed Dose	Not Assessed at Day 169 visit	1	Participants
Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3	XmAb5871 5 mg/kg		13	Participants
Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3	XmAb5871 Fixed Dose		5	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	XmAb5871 5 mg/kg	15
Overall Study	STARTED	XmAb5871 Fixed Dose	5
Overall Study	COMPLETED	XmAb5871 5 mg/kg	12
Overall Study	COMPLETED	XmAb5871 Fixed Dose	4
Overall Study	NOT COMPLETED	XmAb5871 5 mg/kg	3
Overall Study	NOT COMPLETED	XmAb5871 Fixed Dose	1

Source ClinicalTrials.gov

Adverse events22

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	Abdominal pain	Gastrointestinal disorders	XmAb5871 5 mg/kg	3	15	5
other	Abdominal pain	Gastrointestinal disorders	XmAb5871 Fixed Dose	1	5	1
other	Nausea	Gastrointestinal disorders	XmAb5871 5 mg/kg	2	15	2
other	Nausea	Gastrointestinal disorders	XmAb5871 Fixed Dose	2	5	2
other	Vomiting	Gastrointestinal disorders	XmAb5871 5 mg/kg	1	15	1
other	Vomiting	Gastrointestinal disorders	XmAb5871 Fixed Dose	2	5	2
other	Diarrhoea	Gastrointestinal disorders	XmAb5871 5 mg/kg	2	15	2
other	Diarrhoea	Gastrointestinal disorders	XmAb5871 Fixed Dose	0	5	0
other	Chills	General disorders	XmAb5871 5 mg/kg	2	15	2
other	Chills	General disorders	XmAb5871 Fixed Dose	0	5	0

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	XmAb5871 5 mg/kg	0	15
Total, all-cause mortality	XmAb5871 Fixed Dose	0	5
Total, other adverse events	XmAb5871 5 mg/kg	7	15
Total, other adverse events	XmAb5871 Fixed Dose	3	5
Total, serious adverse events	XmAb5871 5 mg/kg	1	15
Total, serious adverse events	XmAb5871 Fixed Dose	1	5

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38251576	DERIVED

Source PubMed

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 comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
XmAb5871 5 mg/kg vs XmAb5871 Fixed Dose: Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3	Trial comparisons
XmAb5871 5 mg/kg vs XmAb5871 Fixed Dose: deaths from any cause	Trial comparisons
XmAb5871 5 mg/kg vs XmAb5871 Fixed Dose: 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/NCT02725476

GET https://conductscience.org/api/trials/v1/NCT02725476/events?page=2

API reference For AI assistants