Systemic Lupus ErythematosusPhase 2NCT02725515

A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus

A Phase 2 study testing XmAb5871 in people with Systemic Lupus Erythematosus, run by Xencor, Inc. at 23 sites in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus Erythematosus (SLE) disease activity improvement achieved by a brief course of disease-suppressing steroid therapy Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Systemic Lupus Erythematosus
What is being tested?: XmAb5871
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 105 participants
Where: 23 sitesUnited States
Study dates: 16 Feb 2016to 17 Jul 2018
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with a diagnosis of SLE as defined by the ACR criteria
Patients have a history of a (+) ANA, (+) ENA or a (+) anti-dsDNA serology documented within one year prior to randomization
Investigator has assessed the patient and in their judgment, the SLE disease activity is not organ threatening
Both investigator and patient agree that it is acceptable to discontinue their current immunosuppressant SLE medications and receive a brief course of IM steroid therapy
If patients are on oral steroids, they must be on the equivalent of ≤15 mg/day of prednisone to enter screening, and must be able to taper to ≤10 mg/day by randomization

Who cannot join

History or evidence of a clinically unstable/uncontrolled disorder, condition or disease, other than SLE that, in the opinion of the investigator would pose a risk to patient safety or interfere with the study evaluation, procedures or completion
Patients who have organ threatening manifestations of SLE including active Class 3 or 4 lupus nephritis requiring induction or maintenance therapy or any other disorder for which stopping SLE therapy is contraindicated
Active CNS lupus such as seizures or psychosis that in the opinion of the investigator would preclude participation
Unstable hemolytic anemia or thrombocytopenia
Patient is pregnant or breast feeding, or planning to become pregnant while participating in the study
Use of any biologic therapy (including belimumab) within 6 months of randomization, or prior exposure to a monoclonal antibody directed to CD20 (such as rituximab) within 12 months of randomization

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Piedmont Atlanta Rheumatology
Atlanta, Georgia, 30309
Emory University School of Medicine
Atlanta, Georgia, 30322
Suny Downstate Medical Center
Brooklyn, New York, 11203
CTRC University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27517
DJL Clinical Research
Charlotte, North Carolina, 28210
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Paramount Medical Research and Consulting LLC
Cleveland, Ohio, 44130
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Center For Rheumatology
Fort Lauderdale, Florida, 33309
UC San Diego
La Jolla, California, 92037
Joshua P June, DO
Lansing, Michigan, 48910
Loma Linda University
Loma Linda, California, 92354
Feinstein Institute for Medical Research
Manhasset, New York, 11030
Yale University School of Medicine
New Haven, Connecticut, 06250
NYU Langone Medical Center
New York, New York, 10016
Hospital for Special Surgery
New York, New York, 10021
Arthritis & Rheumatology Center of Oklahoma, PLLC
Oklahoma City, Oklahoma, 73103
East Bay Rheumatology Medical Group
San Leandro, California, 94578
Washington University
St Louis, Missouri, 63110
Columbia University Medical Center
The Bronx, New York, 10461
Oklahoma Center for Arthritis Therapy & Research
Tulsa, Oklahoma, 74104
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: A Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease Activity

Conditions: Systemic Lupus Erythematosus
Being tested: XmAb5871, Placebo to match XmAb5871
Medical subject headings: Lupus Erythematosus, Systemic

What participants receive

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

XmAb5871Biological
Placebo to match XmAb5871Biological

Study groups in NCT02725515
Study group	Role	What they receive
XmAb5871	Experimental	XmAb5871 administered by IV infusion for up to a total of 16 infusions Receives: Biological: XmAb5871
Placebo	Placebo comparator	Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions Receives: Biological: Placebo to match XmAb5871

What is being measured

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

Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225
Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 225
Measured: Day 225

Secondary outcomes (2)

Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169
Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 169
Measured: Day 169
Time to Loss of Systemic Lupus Erythematosus Disease Activity Improvement Achieved by a Short Period of IM Steroid Therapy in SLE Patients
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.
Measured: 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.

Timeline

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

16 Feb 201617 Jul 2018

First posted1 Apr 2016 (estimated)
Study start16 Feb 2016
Primary completion17 Jul 2018
Study completion17 Jul 2018

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 (3)Papers the sponsor has linked to this study.
Other trials for Systemic Lupus ErythematosusStudies 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: Randomised
Intervention model: Parallel groups
Model description: Randomized (1:1, no stratification), Double-Blinded, Placebo-Controlled
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02725515
Sponsor's protocol ID: XmAb5871-04
Status last verified: Aug 2019
First submitted: 8 Jan 2016
Last updated: 20 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum. 1992 Jun;35(6):630-40. doi: 10.1002/art.1780350606.
PubMed 1599520
Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.
PubMed 11838846
Merrill JT, Guthridge J, Smith M, June J, Koumpouras F, Machua W, Askanase A, Khosroshahi A, Sheikh SZ, Rathi G, Burington B, Foster P, Matijevic M, Arora S, Wang X, Gao M, Wax S, James JA, Zack DJ. Obexelimab in Systemic Lupus Erythematosus With Exploration of Response Based on Gene Pathway Co-Expression Patterns: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial. Arthritis Rheumatol. 2023 Dec;75(12):2185-2194. doi: 10.1002/art.42652.
PubMed 37459248

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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An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
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RecruitingObservational study
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Systemic Lupus Erythematosus
RecruitingObservational study
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All Systemic Lupus Erythematosus trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease Activity
ClinicalTrials.gov ID: NCT02725515
Acronym / sponsor ID: XmAb5871-04
Conditions: Systemic Lupus Erythematosus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Xencor, Inc.Industry (pharma, biotech, devices)
Collaborators: PPD Development, LP, ICON plc
Study start: 16 Feb 2016 (actual)
Primary completion: 17 Jul 2018 (actual)
Study completion: 17 Jul 2018 (actual)
First posted: 1 Apr 2016 (estimated)
Results: Posted 9 Aug 2019

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized (1:1, no stratification), Double-Blinded, Placebo-Controlled

Arm	Type	Receives
XmAb5871	Experimental	Biological: XmAb5871XmAb5871 administered by IV infusion for up to a total of 16 infusions
Placebo	Placebo comparator	Biological: Placebo to match XmAb5871Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients with a diagnosis of SLE as defined by the ACR criteria
Patients have a history of a (+) ANA, (+) ENA or a (+) anti-dsDNA serology documented within one year prior to randomization
Investigator has assessed the patient and in their judgment, the SLE disease activity is not organ threatening
Both investigator and patient agree that it is acceptable to discontinue their current immunosuppressant SLE medications and receive a brief course of IM steroid therapy
If patients are on oral steroids, they must be on the equivalent of ≤15 mg/day of prednisone to enter screening, and must be able to taper to ≤10 mg/day by randomization

Key exclusion criteria (6 listed)

History or evidence of a clinically unstable/uncontrolled disorder, condition or disease, other than SLE that, in the opinion of the investigator would pose a risk to patient safety or interfere with the study evaluation, procedures or completion
Patients who have organ threatening manifestations of SLE including active Class 3 or 4 lupus nephritis requiring induction or maintenance therapy or any other disorder for which stopping SLE therapy is contraindicated
Active CNS lupus such as seizures or psychosis that in the opinion of the investigator would preclude participation
Unstable hemolytic anemia or thrombocytopenia
Patient is pregnant or breast feeding, or planning to become pregnant while participating in the study

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
Placebo to match XmAb5871	Biological	Placebo

Primary outcome

Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225
Time frame: Day 225
Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 225

2 secondary outcomes

Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169
Time frame: Day 169
Time to Loss of Systemic Lupus Erythematosus Disease Activity Improvement Achieved by a Short Period of IM Steroid Therapy in SLE Patients
Time frame: 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.

Results and safety

Results posted to the registry on 9 Aug 2019, 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	53	28
Placebo	52	17

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

Time frame: Day 225. Count of participants. Unit: Participants

Measure	XmAb5871 n = 50	Placebo n = 42
Value	21	12

XmAb5871 vs Placebo: Risk Difference (RD): 13.4 (95% CI -6.6 to 32.6), p = 0.1830, Barnard's Unconditional Exact Test P-val

Population analysed: 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)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event summaries include events reported between randomization and the end of study visit (Day 253). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
XmAb5871	7 of 52 (13.5%)	41 of 52 (78.8%)	0 of 52
Placebo	4 of 52 (7.7%)	28 of 52 (53.8%)	0 of 52

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 1599520Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum. 1992 Jun;35(6):630-40. doi: 10.1002/art.1780350606.
Background: PubMed 11838846Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.
Derived from this study: PubMed 37459248Merrill JT, Guthridge J, Smith M, June J, Koumpouras F, Machua W, Askanase A, Khosroshahi A, Sheikh SZ, Rathi G, Burington B, Foster P, Matijevic M, Arora S, Wang X, Gao M, Wax S, James JA, Zack DJ. Obexelimab in Systemic Lupus Erythematosus With Exploration of Response Based on Gene Pathway Co-Expression Patterns: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial. Arthritis Rheumatol. 2023 Dec;75(12):2185-2194. doi: 10.1002/art.42652.
Individual participant dataSharing planned: No

Related trials for Systemic Lupus Erythematosus

Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
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RecruitingObservational study
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Systemic Lupus Erythematosus
RecruitingObservational study
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RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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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.

The record lists no contact. Use the official record to reach the sponsor.

23 sites 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 Systemic Lupus Erythematosus, run by Xencor, Inc. at 23 sites 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 5 inclusion and 6 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites 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. Some participants in this study may receive a placebo. 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 9 Aug 2019). 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?

Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225 (time frame: Day 225). 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 NCT02725515, which also lists 3 linked publications.

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 20 Aug 2019.