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Monoclonal Antibodies
XmAb5871 for Related Disease
Phase 2
Waitlist Available
Led By John Stone, M.D., M.P.H.
Research Sponsored by Xencor, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline day 1 to day 197
Awards & highlights
No Placebo-Only Group
Summary
The purpose of this Phase 2 study is to investigate the effect of XmAb5871 on IgG4-Related Disease (RD) activity
Eligible Conditions
- Related Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline day 1 to day 197
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline day 1 to day 197
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of Patients With an Improvement in IgG4-RD Activity
Secondary study objectives
Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3
Side effects data
From 2018 Phase 2 trial • 105 Patients • NCT0272551538%
Nausea
23%
Headache
17%
Vomiting
15%
Dizziness
15%
Back pain
13%
Flushing
12%
Pain in extremity
10%
Abdominal pain
10%
Urinary tract infection
10%
Muscle spasms
8%
Fatigue
8%
Hot flush
8%
Non-cardiac chest pain
8%
Upper respiratory tract infection
8%
Diarrhoea
8%
Cough
8%
Nasopharyngitis
6%
Peripheral swelling
6%
Infusion related reaction
6%
Migraine
6%
Anxiety
6%
Oropharyngeal pain
6%
Abdominal pain upper
6%
Acute sinusitis
6%
Sinus congestion
6%
Tachycardia
4%
Arthralgia
4%
Bronchitis
2%
Rash
2%
Atrial fibrillation
2%
Hypertension
2%
Iron deficiency anaemia
2%
Pyrexia
2%
Pneumonia
2%
Systemic lupus erythematosus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
XmAb5871
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: XmAb5871Experimental Treatment1 Intervention
XmAb5871 administered by IV infusion for up to a total of 12 infusions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obexelimab
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Xencor, Inc.Lead Sponsor
30 Previous Clinical Trials
2,632 Total Patients Enrolled
Massachusetts General HospitalOTHER
3,013 Previous Clinical Trials
13,309,291 Total Patients Enrolled
John Stone, M.D., M.P.H.Principal InvestigatorRheumatology Clinic
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