IgG4-RDPhase 2NCT02725476

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

A Phase 2 study testing XmAb5871 in people with IgG4-RD, run by Xencor, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this Phase 2 study is to investigate the effect of XmAb5871 on IgG4-Related Disease (RD) activity Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: IgG4-RD
What is being tested?: XmAb5871
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Mar 2016to Dec 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
Able and willing to complete the entire study according to the study schedule
Able and willing to provide written informed consent

Who cannot join

History or evidence of a clinically unstable/uncontrolled disorder, condition or disease other than IgG4-RD that, in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation, procedures or completion
Malignancy within 5 years (except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin, or prostate cancer with no recurrence ≥3 years following prostatectomy)
Presence of recurrent or chronic infections, defined as ≥3 infections requiring antimicrobials over the past 6 months prior to screening
Active infection requiring hospitalization or treatment with parenteral antimicrobials within the 60 days prior to randomization or oral antimicrobials within the 21 days prior to enrollment
Patient is taking >40 mg of prednisone QD
Prior use of rituximab (or other B cell depleting agents) within 6 months of enrollment. Prior use of any B cell depleting agent greater than 6 months from enrollment is allowed if the CD19+ B cell count is within the normal reference range during screening

Show all 11Show fewer

Use of any investigational agent within 5 half-lives of the agent (or 6 months if the half-life is unknown) prior to enrollment
Immunosuppressive agent use within the three months prior to enrollment
Has received live vaccines within 2 months of enrollment
Patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to end-of-study visit
Unable or unwilling to partake in the follow-up assessments or required protocol procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: An Open-label, Single-arm, Pilot Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease

The purpose of this Phase 2 study is to investigate the effect of XmAb5871 on IgG4-Related Disease (RD) activity

Conditions: IgG4-RD
Being tested: XmAb5871
Medical subject headings: Immunoglobulin G4-Related Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

XmAb5871Biological

Study groups in NCT02725476
Study group	Role	What they receive
XmAb5871	Experimental	XmAb5871 administered by IV infusion for up to a total of 12 infusions Receives: Biological: XmAb5871

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Patients With an Improvement in IgG4-RD Activity
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.
Measured: Baseline Day 1 to Day 169

Secondary outcomes (1)

Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3
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.
Measured: Baseline Day 1 to Day 197

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Dec 2017

First posted1 Apr 2016 (estimated)
Study startMar 2016
Primary completionDec 2017
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for IgG4-RDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02725476
Sponsor's protocol ID: XmAb5871-03
Status last verified: Dec 2018
First submitted: 4 Mar 2016
Last updated: 7 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Perugino CA, Wallace ZS, Zack DJ, Quinn SM, Poma A, Fernandes AD, Foster P, DeMattos S, Burington B, Liu H, Allard-Chamard H, Smith N, Kai X, Xing K, Pillai S, Stone JH. Evaluation of the safety, efficacy, and mechanism of action of obexelimab for the treatment of patients with IgG4-related disease: an open-label, single-arm, single centre, phase 2 pilot trial. Lancet Rheumatol. 2023 Aug;5(8):e442-e450. doi: 10.1016/S2665-9913(23)00157-1. Epub 2023 Jul 24.
PubMed 38251576

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All IgG4-RD trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-arm, Pilot Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease
ClinicalTrials.gov ID: NCT02725476
Acronym / sponsor ID: XmAb5871-03
Conditions: IgG4-RD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Xencor, Inc.Industry (pharma, biotech, devices)
Collaborators: Massachusetts General Hospital
Study start: Mar 2016 (actual)
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 1 Apr 2016 (estimated)
Results: Posted 7 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this Phase 2 study is to investigate the effect of XmAb5871 on IgG4-Related Disease (RD) activity

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
XmAb5871	Experimental	Biological: XmAb5871XmAb5871 administered by IV infusion for up to a total of 12 infusions

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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
Able and willing to complete the entire study according to the study schedule

Key exclusion criteria (11 listed)

History or evidence of a clinically unstable/uncontrolled disorder, condition or disease other than IgG4-RD that, in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation, procedures or completion
Malignancy within 5 years (except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin, or prostate cancer with no recurrence ≥3 years following prostatectomy)
Presence of recurrent or chronic infections, defined as ≥3 infections requiring antimicrobials over the past 6 months prior to screening
Active infection requiring hospitalization or treatment with parenteral antimicrobials within the 60 days prior to randomization or oral antimicrobials within the 21 days prior to enrollment
Patient is taking >40 mg of prednisone QD

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
XmAb5871	Biological	XmAb5871

Primary outcome

Proportion of Patients With an Improvement in IgG4-RD Activity
Time frame: 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.

1 secondary outcome

Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3
Time frame: Baseline Day 1 to Day 197

Results and safety

Results posted to the registry on 7 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
XmAb5871 5 mg/kg	15	12
XmAb5871 Fixed Dose	5	4

Primary outcome: Proportion of Patients With an Improvement in IgG4-RD Activity

Time frame: Baseline Day 1 to Day 169. Count of participants. Unit: Participants

Measure	XmAb5871 5 mg/kg n = 15	XmAb5871 Fixed Dose n = 5
Responder at Day 169 visit	12	4
Non-Responder at Day 169 visit	2	0
Not Assessed at Day 169 visit	1	1

Population analysed: Intent to Treat (ITT) Population: All patients who have received at least a partial dose of XmAb5871.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day 1 (First Dose) through Day 197. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
XmAb5871 5 mg/kg	1 of 15 (6.7%)	7 of 15 (46.7%)	0 of 15
XmAb5871 Fixed Dose	1 of 5 (20%)	3 of 5 (60%)	0 of 5

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38251576Perugino CA, Wallace ZS, Zack DJ, Quinn SM, Poma A, Fernandes AD, Foster P, DeMattos S, Burington B, Liu H, Allard-Chamard H, Smith N, Kai X, Xing K, Pillai S, Stone JH. Evaluation of the safety, efficacy, and mechanism of action of obexelimab for the treatment of patients with IgG4-related disease: an open-label, single-arm, single centre, phase 2 pilot trial. Lancet Rheumatol. 2023 Aug;5(8):e442-e450. doi: 10.1016/S2665-9913(23)00157-1. Epub 2023 Jul 24.
Individual participant dataSharing planned: No

Related trials for IgG4-RD

Active, not recruitingObservational study
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A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Stone, M.D., M.P.H. principal investigator

Rheumatology Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing XmAb5871 in people with IgG4-RD, run by Xencor, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients With an Improvement in IgG4-RD Activity (time frame: Baseline Day 1 to Day 169). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02725476, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2018.