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Monoclonal Antibodies

IgPro20 for POTS

Phase 3

Waitlist Available

Research Sponsored by CSL Behring

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Positive confirmatory standardized standing test at the Screening visit

Be older than 18 years old

Must not have

Treatment with Immunoglobulin G (IgG) or plasmapheresis within 12 weeks before Screening

Presence of active infections including human immunodeficiency virus infection, hepatitis B, hepatitis C, active SARS-CoV-2 infection, or any uncontrolled systemic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and at week 25

Awards & highlights

Summary

This trial is testing the effectiveness, safety, and how the body processes IgPro20 in people with post-COVID-19 POTS.

Who is the study for?

This trial is for individuals who have developed Postural Orthostatic Tachycardia Syndrome (POTS) following a SARS-CoV-2 infection. Participants should be experiencing symptoms like rapid heartbeat when standing up.

What is being tested?

The study is testing the effectiveness and safety of IgPro20, an immunoglobulin therapy, compared to a placebo in treating post-COVID-19 POTS. Patients are randomly assigned to receive either IgPro20 or a placebo without knowing which one they get.

What are the potential side effects?

Possible side effects of IgPro20 may include headache, nausea, reactions at the injection site, fever, fatigue, or allergic responses. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I passed a specific physical test at my screening appointment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had IgG or plasmapheresis in the last 12 weeks.

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I do not have any active infections like HIV, hepatitis B/C, COVID-19, or other uncontrolled infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and at week 25

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and at week 25

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and at week 25 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change from baseline in COMPASS-31 total score

Change from baseline in orthostatic intolerance score of COMPASS-31

Side effects data

From 2018 Phase 4 trial • 49 Patients • NCT03033745

14%

Upper respiratory tract infection

Rash

Injection site pain

Leukopenia

Nasopharyngitis

Hypotension

Injection site swelling

Injection site bruising

Fatigue

Hepatic enzyme increased

Trigeminal neuralgia

Vitamin D deficiency

Tooth abscess

100%

80%

60%

40%

20%

Study treatment Arm

IgPro20 (Manual Push Flow Rate) 120 mL/h

IgPro20 (Pump-assisted Volume) 25 mL

IgPro20 (Pump-assisted Volume) 40 mL

IgPro20 (Pump-assisted Volume) 50 mL

IgPro20 (Pump-assisted Flow Rate) 25 mL/h

IgPro20 (Pump-assisted Flow Rate) 50 mL/h

IgPro20 (Pump-assisted Flow Rate) 75 mL/h

IgPro20 (Pump-assisted Flow Rate) 100 mL/h

IgPro20 (Manual Push Flow Rate) 30 mL/h

IgPro20 (Manual Push Flow Rate) 60 mL/h

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IgPro20Experimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IgPro20

2008

Completed Phase 4

~220

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

CSL BehringLead Sponsor

197 Previous Clinical Trials

1,211,189 Total Patients Enrolled

Study DirectorStudy DirectorCSL Behring

1,252 Previous Clinical Trials

504,202 Total Patients Enrolled

~118 spots leftby Feb 2027

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